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

Primary Purpose

Impulse Control Disorder, Parkinson

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Variation of behaviors of Parkinson's disease
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulse Control Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patient treated with N-acetylcysteine

Patient treated with placebo

Arm Description

Patients randomise in the drug group

Patients randomise in the placebo group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2017
Last Updated
August 3, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03146130
Brief Title
Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulse Control Disorder, Parkinson

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient treated with N-acetylcysteine
Arm Type
Active Comparator
Arm Description
Patients randomise in the drug group
Arm Title
Patient treated with placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomise in the placebo group
Intervention Type
Biological
Intervention Name(s)
Variation of behaviors of Parkinson's disease
Intervention Description
Variation of hyper dopaminergic behaviors of Parkinson's disease
Primary Outcome Measure Information:
Title
Evaluate the variation of the scale of the behavioral evaluation
Description
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.
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa TIR, Dr
Phone
+33322667987
Email
tir.melissa@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa TIR, Dr
Organizational Affiliation
CHU AMIENS-PICARDIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa TIR, Dr
Phone
+33322667987
Email
tir.melissa@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

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

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