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Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders

TerminatedPhase 3

Sponsor: Centre Hospitalier Universitaire, Amiens

Conditions: Impulse Control Disorder, Parkinson

Interventions: Variation of behaviors of Parkinson's disease

Countries: France

Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Parkinson's disease according to UKPDSBB criteria
* Subject aged 18 to 80
* Presence of a mild to moderate impulse control disorder defined by an ECD hyperdopaminergic sub-score (part IV) between 3 and 22 associated with the investigator's assessment
* MMSE ≥ 24
* Ongoing treatment with dopaminergic agonist and / or levodopa
* No change in antiparkinsonian and / or psychotropic treatment in the month preceding inclusion
* Expected stability of antiparkinsonian and / or psychotropic treatment during the study period
* Informed patient consent
* Patient supported by social security
* Presence of a caregiver

Exclusion Criteria:

* Severe TCI defined by a hyperdopaminergic sub-score at ECMP (part IV) greater than 23 associated with the investigator's assessment
* Patient with TCI suspected of having serious legal and / or relationship problems during the study period
* Adaptation of the anti-parkinsonian and / or psychotropic treatment (cf section 6.2) probably necessary during the duration of the study
* Patient treated with naltrexone, amantadine, antipsychotic in the 6 weeks prior to inclusion
* Patient under tutorship or curatorship
* History of hypersensitivity to any of the components or to any of the excipients
* Fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency
* Gastrointestinal duodenal ulcer in progress
* Pregnancy, breastfeeding
* Patients with contra-indicated treatments in association with NAC
* Patient with phenylketonuria
* Patients with proven difficulty in expectorating
* Patients with an asthmatic risk that can lead to bronchospasm
* Patients with intolerance to histamine

Locations (1)

Amiens, Picardie, France