Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT03552068
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03552068
Study Brief:
Protocol Section:
NCT03552068