NCT02934919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 14, 2016

Last Update Submit

October 14, 2016

Conditions

Impulse Control DisordersParkinson Disease

Keywords

NalmefeneImpulse control disordersParkinson's diseaseToleranceEfficacy

Outcome Measures

Primary Outcomes (2)

  • Tolerance of Nalmefene measured by the dropout rate secondary to adverse effects

    at + 3months

  • Efficacy of Nalmefene measured by the change from baseline of the QUIP-RS

    at + 3months

Secondary Outcomes (4)

  • Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale

    at +3 months

  • Change from baseline of the depression assessed by the Hamilton scale

    at +3 months

  • Change from baseline of the motor severity assessed by the Unified Parkinson Disease Rating Scale at +3 months

    at +3 months

  • Change from baseline of hepatic and renal function evaluated with blood samples at +3 months

    at +3 months

Study Arms (1)

nalmefene

EXPERIMENTAL
Drug: Nalmefene

Interventions

NalmefeneDRUG

30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months

nalmefene

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct DisordersParkinson Disease

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Mental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Franck DURIF

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

FR(1)