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Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: (ID-CLO)

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ClinicalTrials.gov Identifier: NCT03552068
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mpulse Control Disorders Drug: placebo Drug: Clonidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Patients under placebo
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

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).


Active Comparator: Patient under clonidine
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
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).




Primary Outcome Measures :
  1. QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale) [ Time Frame: at 8 weeks ]

    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.



Secondary Outcome Measures :
  1. MDS-UPDRS [ Time Frame: at 4 and 8 weeks ]
    The Movement Disorder Society Unified Parkinson Disease Rating

  2. STAI [ Time Frame: at 4 and 8 weeks ]
    State-Trait Anxiety Index

  3. BDI II [ Time Frame: at 4 and 8 weeks ]
    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.

  4. ECMP scores [ Time Frame: at 4 and 8 weeks ]
    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.

  5. QUIP-RS sub-scores [ Time Frame: at 4 weeks ]

    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.


  6. QUIP-RS total score [ Time Frame: at 4 and 8 weeks ]

    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.


  7. PDQ 39 scale (Parkinson Disease Quotation) [ Time Frame: at 4 and 8 weeks ]
    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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Patients with major depression (BDI >27);

  • Patients with another parkinsonian syndrome (Parkinson "plus" or vascular Parkinsonism)
  • Orthostatic hypotension
  • Contraindication to clonidine: Hypersensibility; Severe bradyarythmia due to a cardiac disease
  • Patients receiving a treatment potentially interacting with clonidine
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552068


Contacts
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Contact: LAURENCIN Chloé, Dr +33 4 72 35 72 18 chloe.laurencin@chu-lyon.fr
Contact: CAIRE Catherine 33 4 72 35 72 18 catherine.caire@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Bron, France
Contact: LAURENCIN CHLOE, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: LAURENCIN Chloé, Dr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03552068     History of Changes
Other Study ID Numbers: 69HCL18_0135
2019-000165-20 ( EudraCT Number )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Parkinson's disease
Impulse control disorder
Clonidine
Noradrenergic system
Additional relevant MeSH terms:
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Parkinson Disease
Disease
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action