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

NCT03552068 | Completed Phase 2

• 2 other identifiers: 69HCL18_01352019-000165-20
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Parkinson's Disease; Mpulse Control Disorders

Keywords

Parkinson's disease; Impulse control disorder; Clonidine; Noradrenergic system

Outcome Measures

Primary Outcomes (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.

  at 8 weeks

Secondary Outcomes (7)

• MDS-UPDRS

  at 4 and 8 weeks

• STAI

  at 4 and 8 weeks

• BDI II

  at 4 and 8 weeks

• ECMP scores

  at 4 and 8 weeks

• QUIP-RS sub-scores

  at 4 weeks

Study Arms (2)

Patients under placebo

PLACEBO COMPARATOR

Treatment 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.

Drug: placebo

Patient under clonidine

ACTIVE COMPARATOR

Treatment 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.

Drug: Clonidine

Interventions

placebo DRUG

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).

Patients under placebo

Clonidine DRUG

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).

Patient under clonidine

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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
• 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);
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, France

Location

Related Publications (1)

• 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.

  PMID: 37338615 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• LAURENCIN Chloé, Dr

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 17, 2018
• First Posted: June 11, 2018
• Study Start: May 15, 2019
• Primary Completion: July 15, 2021
• Study Completion: December 3, 2021
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)