Title
Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease
A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease
Phase
Phase 2Lead Sponsor
B&A TherapeuticsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Parkinson DiseaseIntervention/Treatment
Bumetanide white, oblong, scored tablet ...Study Participants
40This 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.
Bumetanide with a titration period
placebo intake identically to group 1
bumetanide with a titration period
placebo intake identically to group 1
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)
