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History of Changes for Study: NCT03146130
Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease (NoISE-PD)
Latest version (submitted August 3, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2017 None (earliest Version on record)
2 August 3, 2018 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Outcome Measures, Study Description, Oversight and Study Identification
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Study NCT03146130
Submitted Date:  May 4, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: PI2016_843_0002
Brief Title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease (NoISE-PD)
Official Title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Not yet recruiting
Study Start: September 20, 2017
Primary Completion: December 20, 2019 [Anticipated]
Study Completion: December 20, 2019 [Anticipated]
First Submitted: May 3, 2017
First Submitted that
Met QC Criteria:
May 4, 2017
First Posted: May 9, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
May 4, 2017
Last Update Posted: May 9, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Hospitalier Universitaire, Amiens
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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). 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.

Detailed Description:
Open or close this module Conditions
Conditions: Impulse Control Disorder
Parkinson
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 70 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Patient treated with N-acetylcysteine Biological: Variation of hyper dopaminergic behaviors of Parkinson's disease
Variation of hyper dopaminergic behaviors of Parkinson's disease
Placebo Comparator: Patient treated with placebo Biological: Variation of hyper dopaminergic behaviors of Parkinson's disease
Variation of hyper dopaminergic behaviors of Parkinson's disease
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To evaluate the variation of the scale of the Behavioral Evaluation of the Parkinson's Disease of Ardouin (ECMP IV)
[ Time Frame: 11 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Melissa TIR, Dr
Telephone: +33322667987
Email: tir.melissa@chu-amiens.fr
Locations: France, Picardie
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Contact:Contact: Melissa TIR, Dr +33322667987 tir.melissa@chu-amiens.fr
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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