Trial Outcomes & Findings for Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations (NCT NCT01634360)
NCT ID: NCT01634360
Last Updated: 2014-07-09
Results Overview
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156
Results posted on
2014-07-09
Participant Flow
Participant milestones
| Measure |
Perampanel (Placebo During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
136
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
49
|
136
|
Reasons for withdrawal
| Measure |
Perampanel (Placebo During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
34
|
|
Overall Study
subject withdrew consent
|
13
|
23
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
14
|
|
Overall Study
Other
|
3
|
20
|
|
Overall Study
Study termination by sponsor
|
18
|
44
|
Baseline Characteristics
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
Baseline characteristics by cohort
| Measure |
Perampanel (Placebo During Core Study)
n=48 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=134 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
27 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
21 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
48 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156Population: Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=45 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=125 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 0
|
-0.51 Hours
Standard Deviation 2.811
|
-0.68 Hours
Standard Deviation 2.479
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 12
|
-0.91 Hours
Standard Deviation 2.913
|
-1.08 Hours
Standard Deviation 2.907
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 24
|
-1.05 Hours
Standard Deviation 2.760
|
-1.15 Hours
Standard Deviation 2.754
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 36
|
-0.76 Hours
Standard Deviation 2.638
|
-1.16 Hours
Standard Deviation 2.959
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 52
|
-0.47 Hours
Standard Deviation 3.443
|
-1.34 Hours
Standard Deviation 2.881
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 78
|
-1.31 Hours
Standard Deviation 2.547
|
-1.54 Hours
Standard Deviation 3.106
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 104
|
-1.14 Hours
Standard Deviation 3.121
|
-1.81 Hours
Standard Deviation 3.149
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 130
|
-0.65 Hours
Standard Deviation 3.710
|
-1.62 Hours
Standard Deviation 2.953
|
|
Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Week 156
|
-1.00 Hours
Standard Deviation 2.953
|
-1.16 Hours
Standard Deviation 2.672
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156Population: Efficacy Population
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=45 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=125 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 156
|
-0.73 Hours
Standard Deviation 4.105
|
1.76 Hours
Standard Deviation 4.974
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 0
|
0.85 Hours
Standard Deviation 2.856
|
1.17 Hours
Standard Deviation 3.562
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 12
|
1.47 Hours
Standard Deviation 3.200
|
1.32 Hours
Standard Deviation 3.758
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 24
|
1.89 Hours
Standard Deviation 3.712
|
0.86 Hours
Standard Deviation 3.632
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 36
|
1.40 Hours
Standard Deviation 3.895
|
1.52 Hours
Standard Deviation 4.153
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 52
|
0.81 Hours
Standard Deviation 4.101
|
1.79 Hours
Standard Deviation 4.238
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 78
|
1.39 Hours
Standard Deviation 4.450
|
2.52 Hours
Standard Deviation 4.625
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 104
|
0.21 Hours
Standard Deviation 4.541
|
3.30 Hours
Standard Deviation 4.617
|
|
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Week 130
|
-0.98 Hours
Standard Deviation 4.276
|
1.42 Hours
Standard Deviation 4.013
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156Population: Efficacy Population
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
Outcome measures
| Measure |
Perampanel (Placebo During Core Study)
n=45 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=125 Participants
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 0
|
2.30 Scores on scale
Standard Deviation 6.360
|
1.46 Scores on scale
Standard Deviation 7.501
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 12
|
2.45 Scores on scale
Standard Deviation 6.926
|
0.36 Scores on scale
Standard Deviation 7.137
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 24
|
2.43 Scores on scale
Standard Deviation 7.247
|
1.80 Scores on scale
Standard Deviation 7.912
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 36
|
2.69 Scores on scale
Standard Deviation 8.177
|
2.78 Scores on scale
Standard Deviation 9.602
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 52
|
2.76 Scores on scale
Standard Deviation 6.947
|
3.83 Scores on scale
Standard Deviation 9.084
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 78
|
3.64 Scores on scale
Standard Deviation 7.279
|
3.43 Scores on scale
Standard Deviation 9.344
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 104
|
6.25 Scores on scale
Standard Deviation 9.345
|
4.11 Scores on scale
Standard Deviation 10.999
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 130
|
6.05 Scores on scale
Standard Deviation 9.610
|
2.77 Scores on scale
Standard Deviation 9.680
|
|
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Week 156
|
5.72 Scores on scale
Standard Deviation 8.115
|
4.20 Scores on scale
Standard Deviation 9.034
|
Adverse Events
Perampanel (Placebo During Core Study)
Serious events: 13 serious events
Other events: 3 other events
Deaths: 0 deaths
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
Serious events: 39 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perampanel (Placebo During Core Study)
n=48 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=134 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
2.2%
3/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
On and off phenomenon
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Dementia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Dystonia
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Freezing phenomenon
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Paraparesis
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Psycomotor hyperactivity
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Transient ischemic attack
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
6.2%
3/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
4.2%
2/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Hallucination
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
2.2%
3/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Hallucination, visual
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Delusion
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Dissociation
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Humerous fracture
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumor
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
General disorders
Gait disturbance
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
General disorders
Hernia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
General disorders
Sudden death
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Investigations
Blood pressure decrease
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Investigations
Heamatocrit decreased
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Investigations
Investigation
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
1.5%
2/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Social circumstances
Social stay hospitalisation
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.1%
1/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.75%
1/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
Other adverse events
| Measure |
Perampanel (Placebo During Core Study)
n=48 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)
n=134 participants at risk
Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
6.2%
3/48 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
0.00%
0/134 • Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.
|
Additional Information
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Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place