Help us determine the safety and efficacy of VHB937
Upcoming
Study Name
Novartis ASTRALS Trial
PI
Novartis (sponsor). Academic Lead: Nathan Carberry, MD and Michael Benatar, MD, PhD.
Study Type
Interventional (double-blind and open-label phases)
Eligible Population
- Age 18+
- Confirmed diagnosis of ALS
- ALS onset ≤ 24 months
- ALSFRS-R score ≥ 30
- Breathing function (vital capacity) ≥ 60% of normal
- Not currently receiving any other investigational drug treatments
Study Purpose/Goals
To assess the safety, efficacy, and tolerability of VHB937 versus placebo in patients with ALS.
Procedures/Participation
Participation:
- Screening: up to 4 weeks
- Double-blind treatment: 40 weeks
- Option to continue open label
Procedures:
- Drug dosing via infusion every 4 weeks
- Medical history and medication review
- Physical & neurological exam
- Vital signs
- Blood and urine collection
- Lumbar puncture
- Breathing tests
- Neuropsychological testing
- Questionnaires/surveys
- Hand grip strength assessment
- Electrocardiogram
Contact