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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 : Unknown
Verified August 2018 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : May 9, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 9, 2017
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
To evaluate the variation of the scale of the Behavioral Evaluation of the Parkinson's Disease of Ardouin (ECMP IV) [ Time Frame: 11 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders
Official Title  ICMJE Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Impulse Control Disorder
  • Parkinson
Intervention  ICMJE Biological: Variation of behaviors of Parkinson's disease
Variation of hyper dopaminergic behaviors of Parkinson's disease
Study Arms  ICMJE
  • Active Comparator: Patient treated with N-acetylcysteine
    Patients randomise in the drug group
    Intervention: Biological: Variation of behaviors of Parkinson's disease
  • Placebo Comparator: Patient treated with placebo
    Patients randomise in the placebo group
    Intervention: Biological: Variation of behaviors of Parkinson's disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2019
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03146130
Other Study ID Numbers  ICMJE PI2016_843_0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire, Amiens
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa TIR, Dr CHU AMIENS-PICARDIE
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP