Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002805-21 | Other Identifier | 2016-002805-21 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 :
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nalmefene | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene | Drug | 30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Nalmefene measured by the dropout rate secondary to adverse effects | at + 3months | |
| Efficacy of Nalmefene measured by the change from baseline of the QUIP-RS | at + 3months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the cognitive state assessed by the Montreal Cognitive Assessment scale | at +3 months | |
| Change from baseline of the depression assessed by the Hamilton scale | at +3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Franck DURIF | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
Not provided
| ID | Term |
|---|---|
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C038981 | nalmefene |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from baseline of the motor severity assessed by the Unified Parkinson Disease Rating Scale at +3 months | at +3 months |
| Change from baseline of hepatic and renal function evaluated with blood samples at +3 months | at +3 months |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |