Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study (Nalmefene TCI)
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|ClinicalTrials.gov Identifier: NCT02934919|
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was: Not yet recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Impulse Control Disorders Parkinson Disease||Drug: Nalmefene||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||May 2018|
30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months
- 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 ]
- Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale [ Time Frame: at +3 months ]
- Change from baseline of the depression assessed by the Hamilton 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934919
|Contact: Patrick LACARIN||04 73 75 11 email@example.com|
|CHU Clermont-Ferrand||Not yet recruiting|
|Clermont-ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 firstname.lastname@example.org|
|Principal Investigator: Franck DURIF|
|Principal Investigator:||Franck DURIF||University Hospital, Clermont-Ferrand|