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This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Experimental Bumetanide | Experimental | bumetanide with a titration period |
|
| Group 2: Placebo comparator | Placebo Comparator | placebo intake identically to group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bumetanide white, oblong, scored tablet | Drug | Bumetanide with a titration period |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study is the change from baseline (V2) to endpoint (V5) in the MDS-UPDRS III motor score, evaluated 1 hour after the intake of the study treatment (Bumetanide or placebo) in patients in the OFF state. | Between Day 1 and Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from V2 to V5 of the MDS-UPDRS part III and part I measured in a patient in the ON state. | Movement Disorder Society Unified Parkinson's Disease Rating Scale | Between Day 1 and Day 120 |
| Change of scores of the MDS-UPDRS part II, III and IV during the trial, at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). |
| Measure | Description | Time Frame |
|---|---|---|
| Unified dyskinesia rating scale at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). | Day 1, Day 30, Day 60, Day 120 | |
| Awaken time spent in the OFF state, in the ON state with and without dyskinesia. | Between Day 0 (Screening) and Day 1 (V2), then between Day 60 (V4) and Day 120 (V5) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis Ravel, PhD | Contact | 04 38 37 27 40 | denis.ravel@initial-rd.fr | |
| Fanny Kayser | Contact | 04 38 37 27 40 | OP1050@eurofins.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Nantes | Recruiting | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26757306 | Background | Damier P, Hammond C, Ben-Ari Y. Bumetanide to Treat Parkinson Disease: A Report of 4 Cases. Clin Neuropharmacol. 2016 Jan-Feb;39(1):57-9. doi: 10.1097/WNF.0000000000000114. | |
| 29651049 | Background | Lozovaya N, Eftekhari S, Cloarec R, Gouty-Colomer LA, Dufour A, Riffault B, Billon-Grand M, Pons-Bennaceur A, Oumar N, Burnashev N, Ben-Ari Y, Hammond C. GABAergic inhibition in dual-transmission cholinergic and GABAergic striatal interneurons is abolished in Parkinson disease. Nat Commun. 2018 Apr 12;9(1):1422. doi: 10.1038/s41467-018-03802-y. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo white, oblong, scored tablet | Drug | placebo intake identically to group 1 |
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale |
| Day 1, Day 30, Day 60, Day 120 |
| Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). | Day 1, Day 30, Day 60, Day 120 |
| Number of adverse events collected at each visit and phone calls. | Throughout the completion of the study, from Day 1 to Day 135 |
| Patient's Clinical Global Impression (CGI) score at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). | Day 1, Day 30, Day 60, Day 120 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |