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

Study Overview
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Brief Summary
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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).

Detailed Description
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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). They constitute a major public health issue due to their sometimes dramatic socio-occupational and judicial consequences. Most often the therapeutic strategy is to reduce or even stop AD, which can lead to withdrawal symptoms, apathy or aggravation of motor signs. N-acetylcysteine (NAC) may have an interest in the treatment of ICD. This molecule reduces craving in addictions by substance abuse, but also in behavioral addictions, with as a potential mechanism a reduction in levels of plasma alphasynuclein. The main objective of this randomized, double-blind, placebo-controlled, multicenter controlled trial is to demonstrate that a 10-week NAC add-on treatment, compared to placebo, improves the behavioral addictions of Moderate in the MP. The main endpoint will be the variation of the subdivision of the hyperdopaminergic behaviors of the Ardouin Parkinson's Disease Behavioral Assessment (ECMP) scale between the baseline and after 10 weeks of treatment.

Official Title
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Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease

Conditions
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Parkinson, Impulse Control Disorder

Intervention / Treatment
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* Biological: Variation of behaviors of Parkinson's disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient treated with N-acetylcysteine<br>Patients randomise in the drug group | Biological: Variation of behaviors of Parkinson's disease<br>* Variation of hyper dopaminergic behaviors of Parkinson's disease<br>|
| Placebo Comparator: Patient treated with placebo<br>Patients randomise in the placebo group | Biological: Variation of behaviors of Parkinson's disease<br>* Variation of hyper dopaminergic behaviors of Parkinson's disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the variation of the scale of the behavioral evaluation | show that a 10-week treatment with N-acetylcysteine compared to placebo improves the mild-to-moderate impulse control disorders induced by dopaminergic medications in Parkinson's disease. The primary endpoint is the change in score from Part IV of the Ardouin Parkinson's Behavioral Assessment of Parkinson's Disease (ECMP) (ECMP IV), which evaluates hyperdopaminergic behaviors between the baseline and after 10 weeks. treatment. | 11 weeks |