Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amyotrophic Lateral Sclerosis
- Motor Neuron Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open-label, single-arm study without placeboMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
The study will consist of a 4-week lead-in period to obtain a stable baseline measurement of clinical markers of disease and oxidative stress. After the lead-in phase, participants will receive trimetazidine for 12 weeks. Participants will visit the clinic at 6-week intervals, during which we will o...
The study will consist of a 4-week lead-in period to obtain a stable baseline measurement of clinical markers of disease and oxidative stress. After the lead-in phase, participants will receive trimetazidine for 12 weeks. Participants will visit the clinic at 6-week intervals, during which we will obtain a blood sample to measure the pharmacodynamic response. We will also collect information regarding the rate of disease progression (i.e. ALSFRS-R and SVC). At weeks 3 and 9 of treatment, participants will conduct a teleconference visit, during which we will collect data on ALSFRS-R. Adverse events will be collected and recorded throughout the entire trial duration. At the end of the on-treatment period, a close-out visit will occur after four weeks. The total study period per participant will be 20 weeks.
Tracking Information
- NCT #
- NCT04788745
- Collaborators
- FightMND
- UMC Utrecht
- King's College London
- Julius Clinical, The Netherlands
- Investigators
- Principal Investigator: Shyuan Ngo, PhD The University of Queensland Principal Investigator: Robert Henderson, MBBS, PhD Royal Brisbane & Women's Hospital Principal Investigator: Leonard van den Berg, MD, PhD UMC Utrecht Principal Investigator: Ammar Al-Chalabi, MB ChB, PhD King's College London Principal Investigator: Frederik Steyn, PhD The University of Queensland Principal Investigator: Ruben van Eijk, MD, PhD UMC Utrecht
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