Trial Outcomes & Findings for Naltrexone for Impulse Control Disorders in Parkinson's Disease (NCT NCT01052831)
NCT ID: NCT01052831
Last Updated: 2015-08-06
Results Overview
The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used.
COMPLETED
PHASE4
50 participants
The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).
2015-08-06
Participant Flow
Participant milestones
| Measure |
Naltrexone
For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
|
Placebo
Participants received the placebo treatment which looked identical to active study medication.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naltrexone for Impulse Control Disorders in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Naltrexone
n=26 Participants
Participants will receive Naltrexone
Naltrexone: 50-100 mg qd for 8 weeks
|
Placebo
n=24 Participants
Participants will receive placebo treatment
Placebo: 50-100 mg qd for 8 weeks
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used.
Outcome measures
| Measure |
Naltrexone
n=26 Participants
For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
|
Placebo
n=24 Participants
Participants received the placebo treatment which looked identical to active study medication.
|
|---|---|---|
|
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale
|
54.4 percentage of responders
|
33.1 percentage of responders
|
SECONDARY outcome
Timeframe: The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).Population: A linear mixed-effects model was used to estimate changes in QUIP-RS ICD scores from baseline to termination (visit 5, 8 weeks after baseline). Positive estimated change values represent a decrease in severity (frequency) of symptoms.
The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.
Outcome measures
| Measure |
Naltrexone
n=26 Participants
For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
|
Placebo
n=24 Participants
Participants received the placebo treatment which looked identical to active study medication.
|
|---|---|---|
|
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
|
14.92 Change in points on a scale (QUIP-RS)
Interval 9.89 to 19.96
|
7.55 Change in points on a scale (QUIP-RS)
Interval 2.45 to 12.66
|
Adverse Events
Naltrexone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=24 participants at risk
For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
|
Placebo
n=24 participants at risk
Participants received the placebo treatment which looked identical to active study medication.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Number of events 7
A total of 48 patients provided adverse event data.
|
0.00%
0/24
A total of 48 patients provided adverse event data.
|
|
General disorders
Dizziness
|
16.7%
4/24 • Number of events 4
A total of 48 patients provided adverse event data.
|
4.2%
1/24 • Number of events 1
A total of 48 patients provided adverse event data.
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Number of events 5
A total of 48 patients provided adverse event data.
|
16.7%
4/24 • Number of events 4
A total of 48 patients provided adverse event data.
|
|
General disorders
Blood Pressure Change
|
25.0%
6/24 • Number of events 6
A total of 48 patients provided adverse event data.
|
41.7%
10/24 • Number of events 10
A total of 48 patients provided adverse event data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place