Parkinson DiseasePhase 2CUREPARKNCT03899324
Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease
A Phase 2 study testing Bumetanide white, oblong, scored tablet in people with Parkinson Disease, run by B&A Therapeutics at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Bumetanide white, oblong, scored tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Nantes
Nantes, 44093
LE DILY Séverine, 02 40 16 52 86
Philippe DAMIER, Pr
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Bumetanide white, oblong, scored tablet, Placebo white, oblong, scored tablet
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bumetanide white, oblong, scored tabletDrug
Bumetanide with a titration period
Placebo white, oblong, scored tabletDrug
placebo intake identically to group 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Experimental Bumetanide | Experimental | bumetanide with a titration period Receives: Drug: Bumetanide white, oblong, scored tablet |
| Group 2: Placebo comparator | Placebo comparator | placebo intake identically to group 1 Receives: Drug: Placebo white, oblong, scored tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Movement Disorder Society Unified Parkinson's Disease Rating Scale
Measured: 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).
Movement Disorder Society Unified Parkinson's Disease Rating Scale
Measured: Day 1, Day 30, Day 60, Day 120
Stand-Walk-Sit test at D1 (V2), D30 (V3), D60 (V4) and D120 (V5).
Measured: Day 1, Day 30, Day 60, Day 120
Number of adverse events collected at each visit and phone calls.
Measured: Throughout the completion of the study, from Day 1 to Day 135
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start26 Apr 2019
- Primary completionSep 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B&A Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899324
- Sponsor's protocol ID
- CUREPARK/OP105018.BAT
- Acronym
- CUREPARK
- Status last verified
- Jul 2019
- First submitted
- 29 Mar 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26757306Lozovaya 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.
PubMed 29651049
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03899324
- Acronym / sponsor ID
- CUREPARK / CUREPARK/OP105018.BAT
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- B&A TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Experimental Bumetanide | Experimental | Drug: Bumetanide white, oblong, scored tabletbumetanide with a titration period |
| Group 2: Placebo comparator | Placebo comparator | Drug: Placebo white, oblong, scored tabletplacebo intake identically to group 1 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bumetanide white, oblong, scored tabletBumetanide with a titration period | Drug | Group 1: Experimental Bumetanide |
| Placebo white, oblong, scored tabletplacebo intake identically to group 1 | Drug | Group 2: Placebo comparator |
Primary outcome
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
4 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 26757306Damier 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.
- Background: PubMed 29651049Lozovaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bumetanide white, oblong, scored tablet in people with Parkinson Disease, run by B&A Therapeutics at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Ravel, PhD (04 38 37 27 40, denis.ravel@initial-rd.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.