A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene
A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska
Trial Phone: 321.841.1324 ; 321-841-4717
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IRB No: W23.027.02
Protocol Abbrev: BIIB105
Principal Investigator: Vahid Tohidi, MD, PhD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: 275AS101
Treatment: BIIB105
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04494256
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Objective
To evaluate the safety and tolerability of BIIB105 in participants with ALS or polyQ-ALS.
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Key Eligibility
Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene
