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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01052831 |
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Date of registration:
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15/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Naltrexone for Impulse Control Disorders in Parkinson's Disease
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Scientific title:
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Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01052831 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Weintraub, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Diagnosis of possible or probable idiopathic Parkinson's disease (PD).
2. Ages 18-85 years.
3. Diagnosis of compulsive gambling, buying, sex behavior, or eating of >2 months
duration.
4. Impulse control disorder (ICD) behaviors that began after PD onset and in context of
dopamine agonist (DA) treatment.
5. 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.
6. Subjects are capable of giving informed consent, supported by not having significant
cognitive impairment based on Montreal Cognitive Assessment score =24.
7. Willingness to maintain existing PD pharmacotherapy regimen for the duration of the
study.
Exclusion Criteria
1. Active suicide ideation.
2. 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).
3. ICD behaviors so severe that modification of DA treatment is clinically warranted, as
judged by PI.
4. Deep brain stimulation surgery in the past year.
5. Evidence for significant liver disease by chart review or patient history (e.g.,
cirrhosis, chronic hepatitis, liver transplant, or liver cancer).
6. Meeting diagnostic criteria for alcohol or opiate dependence.
7. Meeting diagnostic criteria for Dopamine Dysregulation Syndrome.
8. Use of opioids for pain management.
9. 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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Impulse Control Disorder
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Parkinson Disease
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Intervention(s)
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Drug: Naltrexone
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Drug: Placebo
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Primary Outcome(s)
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Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale
[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).]
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Secondary Outcome(s)
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Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
[Time Frame: The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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