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Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study (Nalmefene TCI)

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ClinicalTrials.gov Identifier: NCT02934919
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive shopping …) are an increasingly recognized psychiatric complications in Parkinson's disease (PD). Therapeutic management of these disorders is important since they have an impact on patient quality of life. Dopamine agonists play a key role in the emergence of ICD.

Animal models and imaging underline the implication of opioid system in the genesis of ICD.

An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al 2014 have found that patients treated by naltrexone showed an interesting decrease of their ICDs measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the severity of pathological gambling in patients treated with nalmefene.

The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment of ICDs in PD.


Condition or disease Intervention/treatment Phase
Impulse Control Disorders Parkinson Disease Drug: Nalmefene Phase 2

Detailed Description:

In this open study, 30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months.

Patients will be evaluated 2 times: at inclusion visit (J0) and 3 months after (at the end of the study, +3months).

At each time, patients will have :

  • a clinical and neurological evaluation
  • neuropsychological tests for cognitive, depression and TCI evaluations.
  • blood sample to test hepatic and renal functions
  • tolerance evaluation with a list of adverse events/effects

Patients will be contacted 3 times by phone: 2 weeks after inclusion, 1 month after inclusion and 2 months after inclusion, to note the presence of adverse events.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study
Study Start Date : December 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nalmefene Drug: Nalmefene
30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months




Primary Outcome Measures :
  1. Tolerance of Nalmefene measured by the dropout rate secondary to adverse effects [ Time Frame: at + 3months ]
  2. Efficacy of Nalmefene measured by the change from baseline of the QUIP-RS [ Time Frame: at + 3months ]

Secondary Outcome Measures :
  1. Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale [ Time Frame: at +3 months ]
  2. Change from baseline of the depression assessed by the Hamilton scale [ Time Frame: at +3 months ]
  3. Change from baseline of the motor severity assessed by the Unified Parkinson Disease Rating Scale at +3 months [ Time Frame: at +3 months ]
  4. Change from baseline of hepatic and renal function evaluated with blood samples at +3 months [ Time Frame: at +3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient suffering of Parkinson's disease
  • Male or Female aged from 18 to 80 years old
  • Diagnosis of ICDs with the Ardouin Scale of Behavior in Parkinson's Disease (ASBPD) with a score of at least 2 on one of the Item of hyperdopaminergic symptoms
  • No modification of the treatments for PD since 3 months
  • No modification of parameters of deep brain stimulation since 6 months
  • Patients who understood and signed the consent form
  • Patients having a social security

Exclusion Criteria:

  • Contraindication to nalmefene (Patients receiving opioid antalgics, antecedent of opioid dependence, dopamine agonist withdrawal syndrome, opioid consumption, patient receiving methadone or buprenorphine, severe hepatic failure, severe renal failure, antecedent of alcohol withdrawal, galactose intolerance, lactose deficit or glucose malabsorption, pregnant women)
  • Cognitive impairment with Mini Mental Score < 26
  • Psychiatric comorbidities (bipolar disease, schizophrenia)
  • Patient participating in another therapeutic study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934919


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Not yet recruiting
Clermont-ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Franck DURIF         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Franck DURIF University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02934919     History of Changes
Other Study ID Numbers: CHU-0286
2016-002805-21 ( Other Identifier: 2016-002805-21 )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Nalmefene
Impulse control disorders
Parkinson's disease
Tolerance
Efficacy
Additional relevant MeSH terms:
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Peripheral Nervous System Agents
Parkinson Disease
Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
Naltrexone
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Alcohol Deterrents