NCT03146130

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

May 3, 2017

Last Update Submit

August 3, 2018

Conditions

Impulse Control DisorderParkinson

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patient treated with N-acetylcysteine

ACTIVE COMPARATOR

Patients randomise in the drug group

Biological: Variation of behaviors of Parkinson's disease

Patient treated with placebo

PLACEBO COMPARATOR

Patients randomise in the placebo group

Biological: Variation of behaviors of Parkinson's disease

Interventions

Variation of behaviors of Parkinson's diseaseBIOLOGICAL

Variation of hyper dopaminergic behaviors of Parkinson's disease

Patient treated with N-acetylcysteinePatient treated with placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Expected stability of antiparkinsonian and / or psychotropic treatment during the study period
  • Informed patient consent
  • Patient supported by social security
  • Presence of a caregiver

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Melissa TIR, Dr

    CHU AMIENS-PICARDIE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa TIR, Dr

CONTACT

+33322667987tir.melissa@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 9, 2017

Study Start

July 5, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations

FR(1)