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Study of Naltrexone for Impulse Control Disorders in Parkinson’s Disease

Official Study Title: Randomized, double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. placebo-controlled study of naltrexone for impulse control disorders in Parkinson’s disease
Sponsor: Funded by the Michael J. Fox Foundation for Parkinson’s Research
Clinicaltrials.gov ID: NCT01052831
Study ID: 810624

Summary

Impulse control disorders (ICDs), including compulsive gambling, sexual behavior, buying, and eating, are increasingly recognized as a significant clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. problem in Parkinson’s disease (PD), occurring in up to 15 percent of people with PD.  Dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonist (DA) treatment is thought to be the primary risk factor for the development of ICDs in PD.  ICDs often lead to significant impairments in psychosocial functioning, interpersonal relationships, and quality of life.  The management of ICDs in the context of PD can be complex.  People with PDs may be reluctant to discontinue DA treatment due to the motor benefits derived from treatment, so they often have chronic symptoms.  Thus, additional treatment approaches are needed.

A medication shown to be efficacious for the treatment of ICDs with minimal impact on parkinsonism would allow many ICD people with PD to continue on full-dose DA treatment.  Naltrexone, a long-acting opioid receptor antagonist, helps in the treatment of alcohol and opioid dependence.  In addition, placebo-controlled studies have demonstrated that it helps in the treatment of pathological gambling in the general population.  Opioids regulate dopamine pathways in areas of the brain linked with impulse control disorders, and opioid antagonists block opioid receptors in these regions.  In this study, 48 PD participants with an ICD will be treated either with naltrexone (50-100 mg/day) or placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. for a period of eight weeks.  The study will assess if naltrexone improves ICD symptoms in PD and is well tolerated.  To the researchers’ knowledge, the proposed study is the first controlled trial of an agent to treat ICDs in PD. 

Study Phase

Phase 4
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Impulse Control Disorders

Time Commitment

  • Less than six months
  • All participants will be enrolled in this study for a period of 8 weeks. Participants will be seen for in-person visits at baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. and weeks 2, 4, and 8. To minimize participant burden, all will complete the week 6 visit by telephone. Additionally, research personnel will briefly check in with participants by telephone on a weekly basis, in between the in-person visits.

Eligibility

  • Minimum Age: 40
  • Maximum Age: 75
  • Gender(s) Accepted: Either
  • Minimum Years Since Diagnosis: 1

Inclusion Criteria

  • Diagnosis of possible or probable idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD.
  • Ages 40-75 years.
  • Impulse control disorder behaviors, such as compulsive gambling, buying, sex behaviors, or eating, that began after PD onset and in context of dopamine agonist  Dopamine AgonistA chemical or drug that mimics the role of dopamine in the brain. [e.g. Mirapex (pramipexole), Requip (ropinirole) treatment].
  • Current stable dopamine agonist use.  Participants must be on a dopamine agonist for 6 months and on a stable dose for a minimum of 2 months prior to enrolling the in the study.        
  • Able to provide informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.                                                     
  • Willingness to maintain existing PD pharmacotherapy regimen for the duration of the study.

Exclusion Criteria

  • Active suicidal thoughts.
  • Anticipated need to initiate antidepressant therapy  TherapyAnother word for “treatment”. during the course of the study (participants must be on a dose in the therapeutic range for at least 2 months.  If the participant does need to start antidepressant or change antidepressant dose during the course of the study, he/she will be allowed to continue study participation).
  • Impulse control disorder behaviors so severe that modification of dopamine agonist treatment is clinically warranted, as judged by principal investigator  Principal InvestigatorPerson responsible for management of a clinical trial, ensuring it is conducted in compliance with the study protocol. .
  • Deep Brain Stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. surgery in the past year.
  • Evidence for significant liver disease or liver failure by chart review or medical history (e.g., cirrhosis, chronic hepatitis, liver transplant, or liver cancer).
  • Use of opioids (for example:  Vicodin®, Percocet®, Tylenlol III®) for pain management.
  • Women that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study.  Women of child bearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.

Enrollment

Expected Enrollment: 48 (US)
Date Enrollment Began: Dec 2009
Date Enrollment Ends: Jun 2012
Last Updated Date: Mar 17 2010
Trial Post Date: Mar 11 2010
Website: http://clinicaltrials.gov/ct2/show/NCT01052831

Primary Contacts and Locations

Pennsylvania