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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 January 2022 |
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Main ID: |
NCT03552068 |
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Date of registration:
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17/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial |
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Date of first enrolment:
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May 15, 2019 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03552068 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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LAURENCIN Chloé, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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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. ßHCG 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
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Mpulse Control Disorders
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Intervention(s)
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Drug: Clonidine
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Drug: placebo
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Primary Outcome(s)
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QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale)
[Time Frame: at 8 weeks]
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Secondary Outcome(s)
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MDS-UPDRS
[Time Frame: at 4 and 8 weeks]
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PDQ 39 scale (Parkinson Disease Quotation)
[Time Frame: at 4 and 8 weeks]
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QUIP-RS total score
[Time Frame: at 4 and 8 weeks]
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BDI II
[Time Frame: at 4 and 8 weeks]
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QUIP-RS sub-scores
[Time Frame: at 4 weeks]
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ECMP scores
[Time Frame: at 4 and 8 weeks]
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STAI
[Time Frame: at 4 and 8 weeks]
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Secondary ID(s)
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2019-000165-20
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69HCL18_0135
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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