Impulse Control DisorderPhase 3NoISE-PDNCT03146130
Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders
A Phase 3 study testing Variation of behaviors of Parkinson's disease in people with Impulse Control Disorder and Parkinson, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impulse Control Disorder, Parkinson
- What is being tested?
- Variation of behaviors of Parkinson's disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2019to 20 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Expected stability of antiparkinsonian and / or psychotropic treatment during the study period
- Informed patient consent
- Patient supported by social security
- Presence of a caregiver
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease
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).
Read the 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.
- Conditions
- Impulse Control Disorder, Parkinson
- Being tested
- Variation of behaviors of Parkinson's disease
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variation of behaviors of Parkinson's diseaseBiological
Variation of hyper dopaminergic behaviors of Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with N-acetylcysteine | Active comparator | Patients randomise in the drug group Receives: Biological: Variation of behaviors of Parkinson's disease |
| Patient treated with placebo | Placebo comparator | Patients randomise in the placebo group Receives: Biological: Variation of behaviors of Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start23 Jan 2019
- Primary completion9 Feb 2024
- Study completion20 Jan 2026
Why it stopped: Zambon corparate has decided not to renew the production of the samples.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulse Control DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa TIR, Dr, Principal investigator, CHU AMIENS-PICARDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146130
- Sponsor's protocol ID
- PI2016_843_0002
- Acronym
- NoISE-PD
- Status last verified
- Jun 2026
- First submitted
- 3 May 2017
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03146130
- Acronym / sponsor ID
- NoISE-PD / PI2016_843_0002
- Conditions
- Impulse Control Disorder, Parkinson
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Zambon corparate has decided not to renew the production of the samples.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient treated with N-acetylcysteine | Active comparator | Biological: Variation of behaviors of Parkinson's diseasePatients randomise in the drug group |
| Patient treated with placebo | Placebo comparator | Biological: Variation of behaviors of Parkinson's diseasePatients randomise in the placebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variation of behaviors of Parkinson's diseaseVariation of hyper dopaminergic behaviors of Parkinson's disease | Biological | Patient treated with N-acetylcysteine, Patient treated with placebo |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Zambon corparate has decided not to renew the production of the samples.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa TIR, Dr principal investigator
CHU AMIENS-PICARDIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Variation of behaviors of Parkinson's disease in people with Impulse Control Disorder and Parkinson, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Zambon corparate has decided not to renew the production of the samples.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the variation of the scale of the behavioral evaluation (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.