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Terminated NCT03146130

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

Conditions: Impulse Control Disorder, Parkinson

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 14
Sponsor: Centre Hospitalier Universitaire, Amiens

Location: CHU Amiens Picardie Amiens Picardie

Summary

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 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03146130). StuddyBuddy aggregates publicly available trial information.