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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000165-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS | The Movement Disorder Society Unified Parkinson Disease Rating | at 4 and 8 weeks |
| STAI | State-Trait Anxiety Index | at 4 and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patients with major depression (BDI >19);
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| Name | Affiliation | Role |
|---|---|---|
| LAURENCIN Chloé, Dr | Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37338615 | Result | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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). |
|
| 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. | at 4 and 8 weeks |
| 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. | at 4 and 8 weeks |
| 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. | at 4 weeks |
| 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. | at 4 and 8 weeks |
| 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. | at 4 and 8 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |