Trial Outcomes & Findings for A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients (NCT NCT02337725)
NCT ID: NCT02337725
Last Updated: 2022-03-02
Results Overview
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
From Baseline to Week 26 (LOCF)
Results posted on
2022-03-02
Participant Flow
Participants took part in the study at 68 investigative sites in Japan, from 07-Feb-2015 to 15-Sep-2016.
Participants with diagnosis of Parkinson's disease were enrolled and received one tablet of placebo orally, once daily in a run-in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and Week 0 were randomized in 1:1 to TVP-1012 1 mg or Placebo at Week 0.
Participant milestones
| Measure |
Placebo
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
118
|
|
Overall Study
COMPLETED
|
100
|
110
|
|
Overall Study
NOT COMPLETED
|
26
|
8
|
Reasons for withdrawal
| Measure |
Placebo
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Overall Study
Pretreatment Event/AE before Treatment
|
0
|
1
|
|
Overall Study
Pretreatment Event/AE in Treatment
|
8
|
3
|
|
Overall Study
Major Protocol Deviation
|
0
|
1
|
|
Overall Study
Voluntary Withdrawal
|
14
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
Baseline Characteristics
The number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=118 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 8.81 • n=126 Participants
|
67.4 years
STANDARD_DEVIATION 8.96 • n=118 Participants
|
66.4 years
STANDARD_DEVIATION 8.92 • n=244 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=126 Participants
|
65 Participants
n=118 Participants
|
137 Participants
n=244 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=126 Participants
|
53 Participants
n=118 Participants
|
107 Participants
n=244 Participants
|
|
Region of Enrollment
Japan
|
126 Participants
n=126 Participants
|
118 Participants
n=118 Participants
|
244 Participants
n=244 Participants
|
|
Height
|
159.3 cm
STANDARD_DEVIATION 9.24 • n=126 Participants
|
158.8 cm
STANDARD_DEVIATION 8.86 • n=118 Participants
|
159.0 cm
STANDARD_DEVIATION 9.04 • n=244 Participants
|
|
Weight
|
56.97 kg
STANDARD_DEVIATION 10.218 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
57.91 kg
STANDARD_DEVIATION 11.803 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
57.42 kg
STANDARD_DEVIATION 10.997 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
22.35 kg/m^2
STANDARD_DEVIATION 2.752 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
22.78 kg/m^2
STANDARD_DEVIATION 3.303 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
22.56 kg/m^2
STANDARD_DEVIATION 3.031 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Smoking Classification
Never Smoked
|
75 Participants
n=126 Participants
|
64 Participants
n=118 Participants
|
139 Participants
n=244 Participants
|
|
Smoking Classification
Current Smoker
|
8 Participants
n=126 Participants
|
5 Participants
n=118 Participants
|
13 Participants
n=244 Participants
|
|
Smoking Classification
Ex-Smoker
|
43 Participants
n=126 Participants
|
49 Participants
n=118 Participants
|
92 Participants
n=244 Participants
|
|
Timing of Study Drug Dose
Before Breakfast
|
60 Participants
n=126 Participants
|
59 Participants
n=118 Participants
|
119 Participants
n=244 Participants
|
|
Timing of Study Drug Dose
After Breakfast
|
66 Participants
n=126 Participants
|
59 Participants
n=118 Participants
|
125 Participants
n=244 Participants
|
|
Duration of Parkinson's Disease
|
1.56 years
STANDARD_DEVIATION 1.237 • n=126 Participants
|
1.97 years
STANDARD_DEVIATION 1.972 • n=118 Participants
|
1.76 years
STANDARD_DEVIATION 1.644 • n=244 Participants
|
|
Modified Hoehn & Yahr Stage
|
2.15 Units on a scale
STANDARD_DEVIATION 0.615 • n=126 Participants
|
2.18 Units on a scale
STANDARD_DEVIATION 0.626 • n=118 Participants
|
2.17 Units on a scale
STANDARD_DEVIATION 0.619 • n=244 Participants
|
|
MDS-UPDRS Part II+III Total Score
|
33.8 Scores on a scale
STANDARD_DEVIATION 14.43 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
34.4 Scores on a scale
STANDARD_DEVIATION 16.95 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
34.1 Scores on a scale
STANDARD_DEVIATION 15.66 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
MDS-UPDRS Part I Total Score
|
5.7 Scores on a scale
STANDARD_DEVIATION 3.58 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
5.5 Scores on a scale
STANDARD_DEVIATION 3.83 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
5.6 Scores on a scale
STANDARD_DEVIATION 3.70 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
MDS-UPDRS Part II Total Score
|
7.0 Scores on a scale
STANDARD_DEVIATION 4.64 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
7.2 Scores on a scale
STANDARD_DEVIATION 5.47 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
7.1 Scores on a scale
STANDARD_DEVIATION 5.05 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
MDS-UPDRS Part III Total Score
|
26.8 Scores on a scale
STANDARD_DEVIATION 11.59 • n=126 Participants • The number analyzed is the number of participants with data available for analysis.
|
27.2 Scores on a scale
STANDARD_DEVIATION 13.80 • n=117 Participants • The number analyzed is the number of participants with data available for analysis.
|
27.0 Scores on a scale
STANDARD_DEVIATION 12.68 • n=243 Participants • The number analyzed is the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: From Baseline to Week 26 (LOCF)Population: Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=125 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=115 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
|
1.87 Units on a scale
Standard Error 0.752
|
-4.52 Units on a scale
Standard Error 0.784
|
SECONDARY outcome
Timeframe: Baseline and Week 26 (LOCF)Population: Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
For MDS-UPDRS Part I (non-motor experiences of daily living) scores, the scale range for Part I Total Score was 0-52, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=125 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=116 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
|
0.98 Units on a scale
Standard Error 0.247
|
0.18 Units on a scale
Standard Error 0.257
|
SECONDARY outcome
Timeframe: Baseline and Week 26 (LOCF)Population: Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=116 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part II Total Score
|
2.32 Units on a scale
Standard Error 0.335
|
0.13 Units on a scale
Standard Error 0.350
|
SECONDARY outcome
Timeframe: Baseline and Week 26 (LOCF)Population: Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.
Outcome measures
| Measure |
Placebo
n=125 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=115 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
|
-0.48 Units on a scale
Standard Error 0.639
|
-4.47 Units on a scale
Standard Error 0.666
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
66 Participants
|
73 Participants
|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature (<35.6 °C)
|
20 Participants
|
17 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature (>37.7 °C)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Systolic Blood Pressure (<90 mmHg)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure (<50 mmHg)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure (>100 mmHg)
|
6 Participants
|
9 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Pulse (<45 bpm)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Number of Participants With TEAE Related to Body Weight
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Extrasystoles
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Myocardial infarction
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Electrocardiogram QT prolonged
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=126 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 Participants
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood creatine phosphokinase increased
|
3 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Gamma-glutamyltransferase increased
|
2 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Glycosylated haemoglobin increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Hepatic enzyme increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Liver function test abnormal
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 24 other events
Deaths: 0 deaths
TVP-1012 1mg
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=126 participants at risk
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 participants at risk
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.00%
0/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
1/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
1/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
1/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
1/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic dissection
|
0.79%
1/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=126 participants at risk
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
|
TVP-1012 1mg
n=117 participants at risk
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
7/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
6/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
15.1%
19/126 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.4%
18/117 • Baseline up to Week 26
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER