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

Parkinson Disease Clinical Trial

— Nalmefene TCI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934919
• Other study ID #: CHU-0286
• Secondary ID: 2016-002805-21
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 14, 2016
• Last updated: October 14, 2016
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of Nalmefene measured by the dropout rate secondary to adverse effects		at + 3months	No
Primary	Efficacy of Nalmefene measured by the change from baseline of the QUIP-RS		at + 3months	No
Secondary	Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale		at +3 months	No
Secondary	Change from baseline of the depression assessed by the Hamilton scale		at +3 months	No
Secondary	Change from baseline of the motor severity assessed by the Unified Parkinson Disease Rating Scale at +3 months		at +3 months	No
Secondary	Change from baseline of hepatic and renal function evaluated with blood samples at +3 months		at +3 months	No