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

Primary Purpose

Impulse Control Disorders, Parkinson Disease

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Nalmefene

About this trial

This is an interventional treatment trial for Impulse Control Disorders focused on measuring Nalmefene, Impulse control disorders, Parkinson's disease, Tolerance, Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nalmefene

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Change from baseline of the depression assessed by the Hamilton scale

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

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

Full Information

NCT ID

NCT02934919

First Posted

October 14, 2016

Last Updated

October 14, 2016

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT02934919

Brief Title

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

Acronym

Nalmefene TCI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impulse Control Disorders, Parkinson Disease

Keywords

Nalmefene, Impulse control disorders, Parkinson's disease, Tolerance, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nalmefene

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nalmefene

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

at + 3months

Title

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

Time Frame

at + 3months

Secondary Outcome Measure Information:

Title

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

Time Frame

at +3 months

Title

Change from baseline of the depression assessed by the Hamilton scale

Time Frame

at +3 months

Title

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

Time Frame

at +3 months

Title

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

Time Frame

at +3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franck DURIF

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-ferrand

ZIP/Postal Code

63003

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Franck DURIF

12. IPD Sharing Statement

Learn more about this trial

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

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