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

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ClinicalTrials.gov Identifier: NCT03146130
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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).

Condition or disease Intervention/treatment Phase
Impulse Control Disorder Parkinson Biological: Variation of behaviors of Parkinson's disease Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluate the variation of the scale of the behavioral evaluation [ Time Frame: 11 weeks ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146130


Contacts
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Contact: Melissa TIR, Dr +33322667987 tir.melissa@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Melissa TIR, Dr    +33322667987    tir.melissa@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Melissa TIR, Dr CHU AMIENS-PICARDIE

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03146130     History of Changes
Other Study ID Numbers: PI2016_843_0002
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes