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

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Bumetanide white, oblong, scored tablet

Placebo white, oblong, scored tablet

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Chu NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Experimental Bumetanide

Group 2: Placebo comparator

Arm Description

bumetanide with a titration period

placebo intake identically to group 1

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

Movement Disorder Society Unified Parkinson's Disease Rating Scale

Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).

Number of adverse events collected at each visit and phone calls.

Full Information

NCT ID

NCT03899324

First Posted

March 29, 2019

Last Updated

July 22, 2019

Sponsor

B&A Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03899324

Brief Title

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

Acronym

CUREPARK

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2019 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

B&A Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Experimental Bumetanide

Arm Type

Experimental

Arm Description

bumetanide with a titration period

Arm Title

Group 2: Placebo comparator

Arm Type

Placebo Comparator

Arm Description

placebo intake identically to group 1

Intervention Type

Drug

Intervention Name(s)

Bumetanide white, oblong, scored tablet

Intervention Description

Bumetanide with a titration period

Intervention Type

Drug

Intervention Name(s)

Placebo white, oblong, scored tablet

Intervention Description

placebo intake identically to group 1

Primary Outcome Measure Information:

Title

Time Frame

Between Day 1 and Day 120

Secondary Outcome Measure Information:

Title

Change from V2 to V5 of the MDS-UPDRS part III and part I measured in a patient in the ON state.

Description

Movement Disorder Society Unified Parkinson's Disease Rating Scale

Time Frame

Between Day 1 and Day 120

Title

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).

Description

Movement Disorder Society Unified Parkinson's Disease Rating Scale

Time Frame

Day 1, Day 30, Day 60, Day 120

Title

Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).

Time Frame

Day 1, Day 30, Day 60, Day 120

Title

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 Pre-specified Outcome Measures:

Title

Unified dyskinesia rating scale at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).

Time Frame

Day 1, Day 30, Day 60, Day 120

Title

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)

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Denis Ravel, PhD

Phone

04 38 37 27 40

denis.ravel@initial-rd.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Fanny Kayser

Phone

04 38 37 27 40

OP1050@eurofins.com

Facility Information:

Facility Name

Chu Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LE DILY Séverine

Phone

02 40 16 52 86

First Name & Middle Initial & Last Name & Degree

Philippe DAMIER, Pr

12. IPD Sharing Statement

Citations:

PubMed Identifier

26757306

Citation

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.

Results Reference

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PubMed Identifier

29651049

Citation

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.

Results Reference

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

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