Research Studies
Study Title
Novartis ASTRALS Trial (A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS))
Enrollment Status
Upcoming
Principal Investigators
Novartis (sponsor). Academic Lead: Nathan Carberry, MD and Michael Benatar, MD, PhD.
Study Type
Drug Trial
Goals
To assess the safety, efficacy, and tolerability of VHB937 versus placebo in patients with ALS.
Enrolling
ALS Patients
Eligibility
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- 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 Involvement
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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
Primary Funding Source
Novartis
Related Publications
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Related Presentations & Lectures
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