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

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

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).

Study Overview

• Status: Unknown
• Conditions: Parkinson; Impulse Control Disorder
• Intervention / Treatment: Biological: Variation of behaviors of Parkinson's disease

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Melissa TIR, Dr, CHU Amiens-Picardie

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): December 20, 2019

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders
• Other Study ID Numbers: PI2016_843_0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No