Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease (CUREPARK)
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ClinicalTrials.gov Identifier: NCT03899324 |
Recruitment Status : Unknown
Verified July 2019 by B&A Therapeutics.
Recruitment status was: Recruiting
First Posted : April 2, 2019
Last Update Posted : July 23, 2019
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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:
- Group 1 (20 PD patients): bumetanide
- Group 2 (20 PD patients): placebo intake identically to group 1.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Bumetanide white, oblong, scored tablet Drug: Placebo white, oblong, scored tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease |
Actual Study Start Date : | April 26, 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1: Experimental Bumetanide
bumetanide with a titration period
|
Drug: Bumetanide white, oblong, scored tablet
Bumetanide with a titration period |
Placebo Comparator: Group 2: Placebo comparator
placebo intake identically to group 1
|
Drug: Placebo white, oblong, scored tablet
placebo intake identically to group 1 |
- 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. [ Time Frame: Between Day 1 and Day 120 ]
- Change from V2 to V5 of the MDS-UPDRS part III and part I measured in a patient in the ON state. [ Time Frame: Between Day 1 and Day 120 ]Movement Disorder Society Unified Parkinson's Disease Rating Scale
- 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). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]Movement Disorder Society Unified Parkinson's Disease Rating Scale
- Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]
- Number of adverse events collected at each visit and phone calls. [ Time Frame: Throughout the completion of the study, from Day 1 to Day 135 ]
- Unified dyskinesia rating scale at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]
- Awaken time spent in the OFF state, in the ON state with and without dyskinesia. [ Time Frame: Between Day 0 (Screening) and Day 1 (V2), then between Day 60 (V4) and Day 120 (V5) ]
- Patient's Clinical Global Impression (CGI) score at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic Parkinson's disease fulfilling the UK Parkinson's Disease Brain Bank (UKPDSBB) criteria (cf. Appendix VII)
- 40 < Age < 80 years old
- Hoehn & Yahr 1.5-4 (OFF stage)
- Walking and balance or freezing ≥ 1in the MDS-UPDRS II
- Motor fluctuation defined by a score ≥ 1 on the item "time spent in the OFF state" of the MDS-UPDRS IV
- Dose of L-DOPA ≥ 150 mg/d (concomitant treatment)
- PD medications regimen stable for at least 3 months
- Patients expected to remain on stable doses of PD medications during all the study
- Covered by Health Insurance System
- Able to understand and to sign the informed consent prior to selection
- Negative pregnancy test at screening
- Blood Pressure (BP) and Heart Rate (HR) considered Non Clinicaly Significant (NCS) by investigators
- Electrocardiogram (ECG) recording on a 12-lead ECG considered NCS by investigators
- Laboratory parameters within the normal range of the laboratory. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator
Exclusion Criteria:
- Atypical parkinsonism or drug-induced parkinsonism
- Cognitive impairment (MMSE ≤ 24)
- Active psychiatric disorder (mood disorders, hallucinations or delirium with strong functional impact and not controlled by medication or which happened during the last 3 months before inclusion)
- Treatment by Deep Brain Stimulation or continuous infusion of apomorphin/dopa gel
- Renal or hepatic insufficiency
- Electrolyte disturbances
- A corrected QT (QTcF) interval >450ms for male or >470ms for female on the electrocardiogram
- Any medical condition that might interfere with the protocol except those defined in Section 5.3
- Contraindications to bumetanide : persistent anuria, hepatic encephalopathy included coma
- Women pregnant, nursing or of childbearing age without effective contraception. Patients should not be enrolled if they plan to become pregnant during the time of study participation
- Patient unable to attend scheduled visits or to comply to the protocol
- Patient under legal guardianship or judicial protection
- Patient in the exclusion period of another protocol
- No possibility of contact in case of emergency
- Known allergic reactions induced by Burinex (Bumetanide)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899324
Contact: Denis Ravel, PhD | 04 38 37 27 40 | denis.ravel@initial-rd.fr | |
Contact: Fanny Kayser | 04 38 37 27 40 | OP1050@eurofins.com |
France | |
Chu Nantes | Recruiting |
Nantes, France, 44093 | |
Contact: LE DILY Séverine 02 40 16 52 86 | |
Principal Investigator: Philippe DAMIER, Pr |
Responsible Party: | B&A Therapeutics |
ClinicalTrials.gov Identifier: | NCT03899324 |
Other Study ID Numbers: |
CUREPARK/OP105018.BAT |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | July 23, 2019 |
Last Verified: | July 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Bumetanide Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |