Naltrexone for Impulse Control Disorders in Parkinson's Disease
Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease
1 other identifier
interventional
50
1 country
1
Brief Summary
This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in Parkinson's disease patients taking a dopamine agonist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
June 22, 2015
CompletedAugust 6, 2015
July 1, 2015
3.1 years
January 15, 2010
March 10, 2015
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale
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.
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).
Secondary Outcomes (1)
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).
Study Arms (2)
Naltrexone
ACTIVE COMPARATORFor 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
PLACEBO COMPARATORParticipants received the placebo treatment which looked identical to active study medication.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of possible or probable idiopathic Parkinson's disease (PD).
- Ages 18-85 years.
- Diagnosis of compulsive gambling, buying, sex behavior, or eating of \>2 months duration.
- Impulse control disorder (ICD) behaviors that began after PD onset and in context of dopamine agonist (DA) treatment.
- Current stable DA use. Participants must be on a DA for 6 months and on a stable dose (no changes) for 1 month prior to enrolling the in the study.
- Subjects are capable of giving informed consent, supported by not having significant cognitive impairment based on Montreal Cognitive Assessment score ≥24.
- Willingness to maintain existing PD pharmacotherapy regimen for the duration of the study.
You may not qualify if:
- Active suicide ideation.
- Anticipated need to initiate antidepressant therapy during the course of the study (must be on a dose in the therapeutic range for at least 2 months. If patient does end up needing to start antidepressant or change antidepressant dose during the course of the study, he/she will be allowed to continue study participation).
- ICD behaviors so severe that modification of DA treatment is clinically warranted, as judged by PI.
- Deep brain stimulation surgery in the past year.
- Evidence for significant liver disease by chart review or patient history (e.g., cirrhosis, chronic hepatitis, liver transplant, or liver cancer).
- Meeting diagnostic criteria for alcohol or opiate dependence.
- Meeting diagnostic criteria for Dopamine Dysregulation Syndrome.
- Use of opioids for pain management.
- Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of child bearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Papay K, Xie SX, Stern M, Hurtig H, Siderowf A, Duda JE, Minger J, Weintraub D. Naltrexone for impulse control disorders in Parkinson disease: a placebo-controlled study. Neurology. 2014 Aug 26;83(9):826-33. doi: 10.1212/WNL.0000000000000729. Epub 2014 Jul 18.
PMID: 25037206RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Weintraub
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Weintraub, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 15, 2010
First Posted
January 20, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 6, 2015
Results First Posted
June 22, 2015
Record last verified: 2015-07