Trial Outcomes & Findings for Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment (NCT NCT00489255)
NCT ID: NCT00489255
Last Updated: 2019-01-30
Results Overview
COMPLETED
PHASE4
117 participants
Day 1 (Period 1, Visit 2)
2019-01-30
Participant Flow
Patients were recruited at 24 investigational sites in the United States (US).
Number of participants "STARTED" does not match "Enrollment, Actual" (in protocol section) due to re-randomization design of the study \& phased withdrawal of subjects from Tigan to placebo. Some subjects were included on one treatment in one period and re-randomized to a different treatment in a later period.
Participant milestones
| Measure |
Trimethobenzamide (Tigan®)
Tigan® : Oral capsule, 300mg three times daily.
|
Tigan:Placebo
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Screening and Initial Randomization
STARTED
|
145
|
49
|
|
Screening and Initial Randomization
COMPLETED
|
136
|
46
|
|
Screening and Initial Randomization
NOT COMPLETED
|
9
|
3
|
|
Period 1: Days 1 to 28
STARTED
|
136
|
46
|
|
Period 1: Days 1 to 28
Completed and Follow Period 2
|
94
|
29
|
|
Period 1: Days 1 to 28
Completed But Discontinued Study
|
13
|
5
|
|
Period 1: Days 1 to 28
COMPLETED
|
107
|
34
|
|
Period 1: Days 1 to 28
NOT COMPLETED
|
29
|
12
|
|
Period 2: Days 29 to 56
STARTED
|
64
|
59
|
|
Period 2: Days 29 to 56
Completed and Follow Period 3
|
58
|
52
|
|
Period 2: Days 29 to 56
Completed But Discontinued Study
|
3
|
3
|
|
Period 2: Days 29 to 56
COMPLETED
|
61
|
55
|
|
Period 2: Days 29 to 56
NOT COMPLETED
|
3
|
4
|
|
Period 3: Days 57 to 84
STARTED
|
28
|
82
|
|
Period 3: Days 57 to 84
COMPLETED
|
24
|
78
|
|
Period 3: Days 57 to 84
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Trimethobenzamide (Tigan®)
Tigan® : Oral capsule, 300mg three times daily.
|
Tigan:Placebo
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Screening and Initial Randomization
Discontinued prior to taking study drug
|
9
|
3
|
|
Period 1: Days 1 to 28
Adverse Event
|
21
|
8
|
|
Period 1: Days 1 to 28
Withdrawal by Subject
|
5
|
0
|
|
Period 1: Days 1 to 28
Physician Decision
|
1
|
4
|
|
Period 1: Days 1 to 28
Noncompliance
|
2
|
0
|
|
Period 2: Days 29 to 56
Adverse Event
|
3
|
1
|
|
Period 2: Days 29 to 56
Withdrawal by Subject
|
0
|
3
|
|
Period 3: Days 57 to 84
Adverse Event
|
3
|
3
|
|
Period 3: Days 57 to 84
Withdrawal by Subject
|
1
|
0
|
|
Period 3: Days 57 to 84
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Baseline characteristics by cohort
| Measure |
Trimethobenzamide (Tigan®)
n=134 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=46 Participants
Placebo : Oral capsule, three times daily.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
n=99 Participants
|
63.0 years
n=107 Participants
|
64.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) total score for Period 1
|
49.2 Score on a scale
STANDARD_DEVIATION 21.26 • n=99 Participants
|
47.8 Score on a scale
STANDARD_DEVIATION 17.83 • n=107 Participants
|
48.8 Score on a scale
STANDARD_DEVIATION 20.40 • n=206 Participants
|
|
UPDRS motor score for Period 1
|
25.7 Score on a scale
STANDARD_DEVIATION 15.07 • n=99 Participants
|
25.2 Score on a scale
STANDARD_DEVIATION 12.25 • n=107 Participants
|
25.6 Score on a scale
STANDARD_DEVIATION 14.37 • n=206 Participants
|
|
UPDRS total score for Period 2
|
46.7 Score on a scale
STANDARD_DEVIATION 21.32 • n=99 Participants
|
47.6 Score on a scale
STANDARD_DEVIATION 18.83 • n=107 Participants
|
47.1 Score on a scale
STANDARD_DEVIATION 20.09 • n=206 Participants
|
|
UPDRS motor score for Period 2
|
24.3 Score on a scale
STANDARD_DEVIATION 15.50 • n=99 Participants
|
25.5 Score on a scale
STANDARD_DEVIATION 12.60 • n=107 Participants
|
24.9 Score on a scale
STANDARD_DEVIATION 14.14 • n=206 Participants
|
|
UPDRS total score for Period 3
|
48.1 Score on a scale
STANDARD_DEVIATION 17.84 • n=99 Participants
|
47.5 Score on a scale
STANDARD_DEVIATION 20.87 • n=107 Participants
|
47.6 Score on a scale
STANDARD_DEVIATION 20.06 • n=206 Participants
|
|
UPDRS motor score for Period 3
|
25.5 Score on a scale
STANDARD_DEVIATION 13.58 • n=99 Participants
|
25.1 Score on a scale
STANDARD_DEVIATION 14.69 • n=107 Participants
|
25.2 Score on a scale
STANDARD_DEVIATION 14.35 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Period 1, Visit 2)Population: Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=130 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=44 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Subjects who experienced nausea &/or vomiting[Yes]
|
21 participants
Interval 0.17 to 1.11
|
10 participants
Interval 0.17 to 1.11
|
|
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Subjects who experienced nausea &/or vomiting [No]
|
109 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Days 1-28Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=130 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=44 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Incidence of Nausea and/or Vomiting for Period 1
Yes
|
48 participants
|
24 participants
|
|
Incidence of Nausea and/or Vomiting for Period 1
No
|
82 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Days 29-56Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=63 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=30 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Incidence of Nausea and/or Vomiting for Period 2
Yes
|
15 participants
|
14 participants
|
|
Incidence of Nausea and/or Vomiting for Period 2
No
|
48 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Days 57-84Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=27 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=30 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Incidence of Nausea and/or Vomiting for Period 3
Yes
|
9 participants
|
10 participants
|
|
Incidence of Nausea and/or Vomiting for Period 3
No
|
18 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Days 1-28Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=130 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=44 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
|
0.51 score on a scale
Standard Deviation 1.504
|
0.80 score on a scale
Standard Deviation 1.755
|
SECONDARY outcome
Timeframe: Days 29-56Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=63 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=30 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
|
0.19 score on a scale
Standard Deviation 0.491
|
1.27 score on a scale
Standard Deviation 2.568
|
SECONDARY outcome
Timeframe: Days 57-84Population: Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=27 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=30 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
|
0.27 score on a scale
Standard Deviation 0.684
|
0.21 score on a scale
Standard Deviation 0.392
|
SECONDARY outcome
Timeframe: Day 28 (Visit 3)Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=107 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=34 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Subject Global Evaluation of Randomized Study Medication for Period 1
Excellent
|
61 participants
|
20 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 1
Very good
|
23 participants
|
5 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 1
Good
|
10 participants
|
3 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 1
Fair
|
6 participants
|
3 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 1
Poor
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 56 (Visit 4)Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=61 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=29 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Subject Global Evaluation of Randomized Study Medication for Period 2
Excellent
|
38 participants
|
15 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 2
Very good
|
16 participants
|
4 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 2
Good
|
2 participants
|
2 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 2
Fair
|
3 participants
|
2 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 2
Poor
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 84 (Visit 5)Population: This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=26 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=29 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Subject Global Evaluation of Randomized Study Medication for Period 3
Excellent
|
17 participants
|
24 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 3
Very good
|
4 participants
|
2 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 3
Good
|
3 participants
|
0 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 3
Fair
|
0 participants
|
0 participants
|
|
Subject Global Evaluation of Randomized Study Medication for Period 3
Poor
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 (Visit 2)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=130 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=44 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Median Time to 'on' for Visit 2/Period 1 Injection 1
|
25.0 minutes
Interval 16.0 to 31.0
|
20.0 minutes
Interval 14.0 to 34.0
|
SECONDARY outcome
Timeframe: Day 1 (Visit 2)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=47 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=10 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Median Time to 'on' for Visit 2/Period 1 Injection 2
|
20.0 minutes
Interval 15.0 to 36.0
|
16.5 minutes
Interval 6.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 28Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=94 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=31 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Median Time to 'on' for Visit 3/End of Period 1 Injection
|
12.0 minutes
Interval 10.0 to 15.0
|
10.0 minutes
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: Day 56 (Visit 4)Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=59 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=27 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Median Time to 'on' for Visit 4/End of Period 2 Injection
|
10.0 minutes
Interval 10.0 to 13.0
|
12.0 minutes
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: Day 84 (Visit 5)Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=24 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=27 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Median Time to 'on' for Visit 5/End of Period 3 Injection
|
10.0 minutes
Interval 9.0 to 15.0
|
10.0 minutes
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: Day 1 (Visit 2)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=130 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=44 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
|
35.5 score on a scale
Standard Deviation 13.72
|
35.3 score on a scale
Standard Deviation 13.31
|
SECONDARY outcome
Timeframe: Day 28Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=106 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=33 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
|
34.0 score on a scale
Standard Deviation 14.27
|
34.2 score on a scale
Standard Deviation 13.08
|
SECONDARY outcome
Timeframe: Day 28Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=94 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=30 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
|
20.8 score on a scale
Standard Deviation 13.21
|
21.1 score on a scale
Standard Deviation 12.94
|
SECONDARY outcome
Timeframe: Day 56 (Visit 4)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=60 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=27 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
|
37.1 score on a scale
Standard Deviation 15.07
|
33.3 score on a scale
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: Day 56 (Visit 4)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=59 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=27 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
|
20.9 score on a scale
Standard Deviation 12.86
|
19.0 score on a scale
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: Day 84 (Visit 5)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=26 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=28 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
|
37.7 score on a scale
Standard Deviation 13.42
|
34.3 score on a scale
Standard Deviation 14.95
|
SECONDARY outcome
Timeframe: Day 56 (Visit 4)Population: This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Outcome measures
| Measure |
Trimethobenzamide (Tigan®)
n=24 Participants
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=27 Participants
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
|
22.6 score on a scale
Standard Deviation 13.52
|
21.4 score on a scale
Standard Deviation 14.87
|
Adverse Events
Trimethobenzamide (Tigan®)
Placebo
Serious adverse events
| Measure |
Trimethobenzamide (Tigan®)
n=134 participants at risk
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=106 participants at risk
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.75%
1/134
|
0.00%
0/106
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.75%
1/134
|
0.00%
0/106
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/134
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/134
|
0.00%
0/106
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/134
|
0.94%
1/106
|
|
General disorders
Chest pain
|
0.00%
0/134
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/134
|
0.94%
1/106
|
|
Nervous system disorders
Syncope
|
0.00%
0/134
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.75%
1/134
|
0.00%
0/106
|
|
Vascular disorders
Aortic stenosis
|
0.75%
1/134
|
0.00%
0/106
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/134
|
0.94%
1/106
|
Other adverse events
| Measure |
Trimethobenzamide (Tigan®)
n=134 participants at risk
Tigan® : Oral capsule, 300mg three times daily.
|
Placebo
n=106 participants at risk
Placebo : Oral capsule, three times daily.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
19.4%
26/134
|
13.2%
14/106
|
|
Nervous system disorders
Dizziness
|
14.2%
19/134
|
10.4%
11/106
|
|
Nervous system disorders
Dyskinesia
|
10.4%
14/134
|
7.5%
8/106
|
|
Nervous system disorders
Headache
|
8.2%
11/134
|
1.9%
2/106
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
14.2%
19/134
|
7.5%
8/106
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
6/134
|
6.6%
7/106
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
10/134
|
0.94%
1/106
|
|
General disorders
Fatigue
|
4.5%
6/134
|
2.8%
3/106
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
4.5%
6/134
|
3.8%
4/106
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place