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

Parkinson Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Impulse Control Disorders
• Parkinson Disease

• NCT number: NCT02934919
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin@chu-clermontferrand.fr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2016
• Completion date: May 2018