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Parkinson's DiseasePhase 2ID-CLONCT03552068

Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:

A Phase 2 study testing Clonidine in people with Parkinson's Disease and Mpulse Control Disorders, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease, Mpulse Control Disorders
What is being tested?
Clonidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteFrance
Study dates
15 May 2019to 3 Dec 2021
Phase
Phase 2
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with PD according to MDS (movement disorders society) criteria for at least one year
  • Patients with ICD with a QUIP-RS score ≥10 and/or at least one of the sub-scores in the following range: Pathological gambling between >6 and 12; Pathological gambling between >8 and 12; Hypersexuality between > 8 and 12; Eating between > 7 and 12. The use of "lower" margins will guarantee that patients will present behavioral disturbances severe enough to justify clonidine treatment. On the other hand, the use of "upper" margins will guarantee that the patients included in the trial will not suffer from ICD too severe to ethically participate to a placebo controlled study.
  • Weight between 40 and 95kg
  • Stable antiparkinsonian medication since at least 2 months before randomization and medication supposed to remain stable during the study
  • ICD onset after Parkinson's disease onset and after initiation of dopaminergic drugs
  • No signs of dementia (Montreal Cognitive Assessment, MOCA >20);
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  • No lactose intolerance which may compromise the tolerance of the placebo;
  • Patients with health insurance
  • Patients without judicial protection measure except directly linked to ICD
  • For women of childbearing potential, an effective contraception method for at least 2 months before randomization (as implants or oral oestro-progestative contraceptives), condom use for men during the study. βHCG dosage in urine should be negative at randomization for women.

Who cannot join

  • Patients with major depression (BDI >19);
  • Patients with another parkinsonian syndrome (Parkinson "plus" or vascular Parkinsonism)
  • Orthostatic hypotension
  • Patients with swallowing disorders that may prevent oral medication,
  • Contraindication to clonidine: Hypersensibility; Severe bradyarythmia due to a cardiac disease
  • Patients receiving a treatment potentially interacting with clonidine
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  • Patients with Raynaud's disease or obliterating thromboangiitis
  • Patients With Heart failure or severe coronary artery disease
  • Patients with a drug treatment having a potential interaction with clonidine (see list, appendix 2);
  • Presence of renal failure (Cockcroft-Gault at inclusion visit<30 ml/min/1,73m2);
  • Patients with a present or past history of addiction (apart ICD) or with a substance abuse (except Tabaco)
  • Pregnant or lactating women
  • Already participating in another biomedical research project

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospices Civils de Lyon

    Bron

Other trials in France

About this study

Official title: Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial

Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial.

Being tested
placebo, Clonidine
Keywords
Parkinson's disease, Impulse control disorder, Clonidine, Noradrenergic system
Medical subject headings
Parkinson Disease, 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.

  • placeboDrug

    Treatment (placebo) will be taken during 8 weeks with one visit at 2, 4 and 8 weeks.

    Medication: placebo twice a day (in the morning and evening).

  • ClonidineDrug

    Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. Medication: 75 μg of clonidine twice a day (in the morning and evening).

Study groups in NCT03552068
Study groupRoleWhat they receive
Patients under placeboPlacebo comparatorTreatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. The usual antiparkinsonian treatment of the patient should remain stable throughout the 8 weeks.
Receives: Drug: placebo
Patient under clonidineActive comparatorTreatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. The usual antiparkinsonian treatment of the patient should remain stable throughout the 8 weeks.
Receives: Drug: Clonidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale)

    Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.

    Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.

    Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.

    Measured: at 8 weeks

Secondary outcomes (7)

  1. MDS-UPDRS

    The Movement Disorder Society Unified Parkinson Disease Rating

    Measured: at 4 and 8 weeks

  2. STAI

    State-Trait Anxiety Index

    Measured: at 4 and 8 weeks

  3. BDI II

    Beck Depression Inventory II It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression.

    Measured: at 4 and 8 weeks

  4. ECMP scores

    Behavior evaluation of Parkinson's patients It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression.

    Measured: at 4 and 8 weeks

  5. QUIP-RS sub-scores

    Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the fourth weeks under clonidine.

    It is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder. The sub score are standardized between 0 and 16.

    Measured: at 4 weeks

  6. QUIP-RS total score

    Evolution of QUIP-RS total score and sub-scores Diminution of impulse control disorder severity on total score of the QUIP-RS between the first visit, the fourth and the eighth weeks under clonidine.

    It is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder.

    Measured: at 4 and 8 weeks

  7. PDQ 39 scale (Parkinson Disease Quotation)

    It is a self-administered questionnaire comprised of 39 questions, each of them using a five-point ordinal scoring system, from which a single summary index can be calculated. For the summary index the scores were standardized from 0 to 100, so that higher scores indicate poorer quality of life.

    Measured: at 4 and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start15 May 2019
  3. Primary completion15 Jul 2021
  4. Study completion3 Dec 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552068
Sponsor's protocol ID
69HCL18_0135
Other IDs
2019-000165-20, 2019
Acronym
ID-CLO
Status last verified
Aug 2025
First submitted
17 May 2018
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laurencin C, Timestit N, Marques A, Duchez DD, Giordana C, Meoni S, Huddlestone M, Danaila T, Anheim M, Klinger H, Vidal T, Fatisson M, Caire C, Nourredine M, Boulinguez P, Dhelens C, Ballanger B, Prange S, Bin S, Thobois S. Efficacy and safety of clonidine for the treatment of impulse control disorder in Parkinson's disease: a multicenter, parallel, randomised, double-blind, Phase 2b Clinical trial. J Neurol. 2023 Oct;270(10):4851-4859. doi: 10.1007/s00415-023-11814-y. Epub 2023 Jun 20.

    PubMed 37338615

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clonidine in people with Parkinson's Disease and Mpulse Control Disorders, run by Hospices Civils de Lyon 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 13 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: finished, as of the sponsor's last update on 3 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale) (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552068, which also lists 1 linked publication.

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 3 Sep 2025.

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