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Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease (CUREPARK)

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ClinicalTrials.gov Identifier: NCT03899324
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
B&A Therapeutics

Study Description
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Brief Summary:

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Bumetanide

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]
  4. 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 ]

Other Outcome Measures:
  1. Unified dyskinesia rating scale at D1 (V2), D30 (V3), D60 (V4) and D120 (V5). [ Time Frame: Day 1, Day 30, Day 60, Day 120 ]
  2. 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) ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic Parkinson's disease fulfilling the UK Parkinson's Disease Brain Bank (UKPDSBB) criteria (cf. Appendix VII)
  2. 40 < Age < 80 years old
  3. Hoehn & Yahr 1.5-4 (OFF stage)
  4. Walking and balance or freezing ≥ 1in the MDS-UPDRS II
  5. Motor fluctuation defined by a score ≥ 1 on the item "time spent in the OFF state" of the MDS-UPDRS IV
  6. Dose of L-DOPA ≥ 150 mg/d (concomitant treatment)
  7. PD medications regimen stable for at least 3 months
  8. Patients expected to remain on stable doses of PD medications during all the study
  9. Covered by Health Insurance System
  10. Able to understand and to sign the informed consent prior to selection
  11. Negative pregnancy test at screening
  12. Blood Pressure (BP) and Heart Rate (HR) considered Non Clinicaly Significant (NCS) by investigators
  13. Electrocardiogram (ECG) recording on a 12-lead ECG considered NCS by investigators
  14. 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:

  1. Atypical parkinsonism or drug-induced parkinsonism
  2. Cognitive impairment (MMSE ≤ 24)
  3. 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)
  4. Treatment by Deep Brain Stimulation or continuous infusion of apomorphin/dopa gel
  5. Renal or hepatic insufficiency
  6. Electrolyte disturbances
  7. A corrected QT (QTcF) interval >450ms for male or >470ms for female on the electrocardiogram
  8. Any medical condition that might interfere with the protocol except those defined in Section 5.3
  9. Contraindications to bumetanide : persistent anuria, hepatic encephalopathy included coma
  10. 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
  11. Patient unable to attend scheduled visits or to comply to the protocol
  12. Patient under legal guardianship or judicial protection
  13. Patient in the exclusion period of another protocol
  14. No possibility of contact in case of emergency
  15. Known allergic reactions induced by Burinex (Bumetanide)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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France
Chu Nantes Recruiting
Nantes, France, 44093
Contact: LE DILY Séverine    02 40 16 52 86      
Principal Investigator: Philippe DAMIER, Pr         
Sponsors and Collaborators
B&A Therapeutics
More Information
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Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Bumetanide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action