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Trial record 2 of 9 for:    "Impulse Control Disorder" | "Peripheral Nervous System Agents"

Naltrexone for Impulse Control Disorders in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01052831
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : June 22, 2015
Last Update Posted : August 6, 2015
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Daniel Weintraub, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Impulse Control Disorder
Parkinson Disease
Interventions Drug: Naltrexone
Drug: Placebo
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description 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. Participants received the placebo treatment which looked identical to active study medication.
Period Title: Overall Study
Started 26 24
Completed 22 23
Not Completed 4 1
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description

Participants will receive Naltrexone

Naltrexone: 50-100 mg qd for 8 weeks

Participants will receive placebo treatment

Placebo: 50-100 mg qd for 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
61.3  (9.0) 61.0  (8.2) 61.2  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
10
  38.5%
18
  75.0%
28
  56.0%
Male
16
  61.5%
6
  25.0%
22
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Hispanic or Latino
0
   0.0%
1
   4.2%
1
   2.0%
Not Hispanic or Latino
26
 100.0%
23
  95.8%
49
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale
Hide Description

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.

Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
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.
Participants received the placebo treatment which looked identical to active study medication.
Overall Number of Participants Analyzed 26 24
Measure Type: Number
Unit of Measure: percentage of responders
54.4 33.1
2.Secondary Outcome
Title Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
Hide Description 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.
Time Frame The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
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.
Participants received the placebo treatment which looked identical to active study medication.
Overall Number of Participants Analyzed 26 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Change in points on a scale (QUIP-RS)
14.92
(9.89 to 19.96)
7.55
(2.45 to 12.66)
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 48 patients provided adverse event data.
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description 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. Participants received the placebo treatment which looked identical to active study medication.
All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/24 (75.00%)      14/24 (58.33%)    
Gastrointestinal disorders     
Nausea   7/24 (29.17%)  7 0/24 (0.00%)  0
General disorders     
Dizziness   4/24 (16.67%)  4 1/24 (4.17%)  1
Blood Pressure Change   6/24 (25.00%)  6 10/24 (41.67%)  10
Nervous system disorders     
Headache   5/24 (20.83%)  5 4/24 (16.67%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Weintraub
Organization: University of Pennsylvania
Phone: 12153498389
EMail: Daniel.Weintraub@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Daniel Weintraub, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01052831     History of Changes
Other Study ID Numbers: 810624
First Submitted: January 15, 2010
First Posted: January 20, 2010
Results First Submitted: March 10, 2015
Results First Posted: June 22, 2015
Last Update Posted: August 6, 2015