Back to resultsStudy of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: (ID-CLO)
Primary Purpose
Parkinson's Disease, Mpulse Control Disorders
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
placebo
Clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Impulse control disorder, Clonidine, Noradrenergic system
Eligibility 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 >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);
- 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
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Patients under placebo
Patient under clonidine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
MDS-UPDRS
The Movement Disorder Society Unified Parkinson Disease Rating
STAI
State-Trait Anxiety Index
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03552068
Brief Title
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:
Acronym
ID-CLO
Official Title
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mpulse Control Disorders
Keywords
Parkinson's disease, Impulse control disorder, Clonidine, Noradrenergic system
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients under placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Patient under clonidine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
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 Measure Information:
Title
QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale)
Description
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.
Time Frame
at 8 weeks
Secondary Outcome Measure Information:
Title
MDS-UPDRS
Description
The Movement Disorder Society Unified Parkinson Disease Rating
Time Frame
at 4 and 8 weeks
Title
STAI
Description
State-Trait Anxiety Index
Time Frame
at 4 and 8 weeks
Title
BDI II
Description
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.
Time Frame
at 4 and 8 weeks
Title
ECMP scores
Description
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.
Time Frame
at 4 and 8 weeks
Title
QUIP-RS sub-scores
Description
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.
Time Frame
at 4 weeks
Title
QUIP-RS total score
Description
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.
Time Frame
at 4 and 8 weeks
Title
PDQ 39 scale (Parkinson Disease Quotation)
Description
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.
Time Frame
at 4 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 >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);
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURENCIN Chloé, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:
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