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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2019-12-20

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).

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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.

Conditions

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Impulse Control Disorder Parkinson

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Patient treated with N-acetylcysteine

Patients randomise in the drug group

Group Type ACTIVE_COMPARATOR

Variation of behaviors of Parkinson's disease

Intervention Type BIOLOGICAL

Variation of hyper dopaminergic behaviors of Parkinson's disease

Patient treated with placebo

Patients randomise in the placebo group

Group Type PLACEBO_COMPARATOR

Variation of behaviors of Parkinson's disease

Intervention Type BIOLOGICAL

Variation of hyper dopaminergic behaviors of Parkinson's disease

Interventions

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Variation of behaviors of Parkinson's disease

Variation of hyper dopaminergic behaviors of Parkinson's disease

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No