NCT03899324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Apr 2019

Typical duration for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

March 29, 2019

Last Update Submit

July 22, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (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.

    Between Day 1 and Day 120

Secondary Outcomes (4)

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

    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).

    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

Other Outcomes (3)

  • 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)

  • 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

Study Arms (2)

Group 1: Experimental Bumetanide

EXPERIMENTAL

bumetanide with a titration period

Drug: Bumetanide white, oblong, scored tablet

Group 2: Placebo comparator

PLACEBO COMPARATOR

placebo intake identically to group 1

Drug: Placebo white, oblong, scored tablet

Interventions

Bumetanide white, oblong, scored tabletDRUG

Bumetanide with a titration period

Group 1: Experimental Bumetanide
Placebo white, oblong, scored tabletDRUG

placebo intake identically to group 1

Group 2: Placebo comparator

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease fulfilling the UK Parkinson's Disease Brain Bank (UKPDSBB) criteria (cf. Appendix VII)
  • \< 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

You may not qualify if:

  • Atypical parkinsonism or drug-induced parkinsonism
  • Cognitive impairment (MMSE ≤ 24)
  • 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
  • No possibility of contact in case of emergency
  • Known allergic reactions induced by Burinex (Bumetanide)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nantes

Nantes, 44093, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26757306BACKGROUND

  • 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.

    PMID: 29651049BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Denis Ravel, PhD

CONTACT

04 38 37 27 40denis.ravel@initial-rd.fr

Fanny Kayser

CONTACT

04 38 37 27 40OP1050@eurofins.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

April 26, 2019

Primary Completion

September 1, 2020

Study Completion

August 1, 2021

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

FR(1)