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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02934919
• Date of registration: 14/10/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study Nalmefene TCI
• Scientific title: Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study
• Date of first enrolment: December 2016
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02934919
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Patrick LACARIN

• Name: Patrick LACARIN

• Name: Franck DURIF
• Affiliation: University Hospital, Clermont-Ferrand

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Impulse Control Disorders

Parkinson Disease

Intervention(s)

Drug: Nalmefene

Primary Outcome(s)

Tolerance of Nalmefene measured by the dropout rate secondary to adverse effects [Time Frame: at + 3months]

Efficacy of Nalmefene measured by the change from baseline of the QUIP-RS [Time Frame: at + 3months]

Secondary Outcome(s)

Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale [Time Frame: at +3 months]

Change from baseline of the motor severity assessed by the Unified Parkinson Disease Rating Scale at +3 months [Time Frame: at +3 months]

Change from baseline of hepatic and renal function evaluated with blood samples at +3 months [Time Frame: at +3 months]

Change from baseline of the depression assessed by the Hamilton scale [Time Frame: at +3 months]

Secondary ID(s)

2016-002805-21

CHU-0286

Source(s) of Monetary Support

Please refer to primary and secondary sponsors