Help us determine the safety and efficacy of multiple experimental drugs in a single trial (one drug per participant)
Active - Not Recruiting
Study Name
Healey ALS Platform Trial
PI
Volkan Granit, MD, MSc and Michael Benatar, MD, PhD
Study Type
Interventional (Platform Clinical Trial). Randomized. Placebo-controlled.
Eligible Population
Individuals affected with ALS, onset of weakness in the past 36 months, and breathing function (vital capacity) at least 50% of normal. (Other, study drug-specific, eligibility criteria may also apply.)
Study Purpose/Goals
To evaluate the safety and efficacy of multiple experimental agents compared to shared placebo, under the auspice of a single platform trial
- Previous agents evaluated include:
- Regimen A: Zilucoplan
- Regimen B: Verdiperstat
- Regimen C: Bioenergetic nanocatalysis (CNM-Au8-nanocrystaline gold)
- Regimen D: pridopidine
- Regimen E: Trehalose (SLS-005)
- Regimen F: ABBV-CLS-7262
- Regimen G: DNL343
- Current agents evaluated include:
Procedures/Participation
Participation:
- 28 weeks of participation
-
- Screening: up to 4 weeks
- Double-blind treatment: 24 weeks
- Option to continue open label or re-randomize to receive a new experimental agent
Procedures:
- Medical history and medication review
- Drug dosing with compliance tracking
- Breathing tests
- Neuropsychological testing
- Questionnaires/surveys
- Physical exam
- Neurological exam
- Electrocardiogram
- Blood and urine collection
- Optional DNA and CSF collection
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Contact
Join our family - together, we can change the course of this disease.
Join our family
Together, we can change the course of this disease.
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