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Molecular Hydrogen in Parkinson's Disease
NCT03971617Phase 3
Key facts
- Status
- Terminated
- Start
- May 2019
- Primary completion
- Apr 2021
- Countries
- 1
- Sponsor
- Stony Brook University
- Modality
- Inhalation Devices, Small Molecules
- Drugs
- Molecular hydrogen
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 3, randomised, double-blind trial in Parkinson's disease (PD) comparing Hydrogen tablets with Placebo tablets (2 arms). Primary endpoint: Number of Treatment-emergent Adverse Events at 56 weeks. Started May 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydrogen tablets
Hydrogen-enriched water (80 mg magnesium/tablet, ~1.6 ppm H2)
Placebo tablets
Placebo water (80 mg magnesium/tablet, no H2)
03
Who it enrols
Patients with early-stage Parkinson's Disease (diagnosis < 3 years, Hoehn & Yahr < III) willing to go off medication for assessments.
04
Endpoints
Primary
Number of Treatment-emergent Adverse Events
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
Parkinson's Disease Quality of Life Questionnaire
Montreal Cognitive Assessment
Combined Part I, Part II, Part III, and Part IV Subscales of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale
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