4494256
Last Update Posted: 2024-09-19
Recruiting has ended
All Genders accepted | 18 Years + |
99 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
The ALSpire Study is a clinical trial evaluating the investigational drug BIIB105 in adults living with amyotrophic lateral sclerosis (ALS).
The ALSpire Study consists of two parts:
- Part 1: 6-month placebo-controlled study. During Part 1, participants are randomly assigned to receive either BIIB105 or placebo in a 3:1 or 2:1 ratio (depending on the participant's assigned Cohort).
- Part 2: up to 3-year long-term open-label extension. During Part 2, all participants receive BIIB105.
The objectives of the study are to evaluate:
- The safety and tolerability of BIIB105 in people with ALS
- What the body does to BIIB105 (also called "pharmacokinetics")
- What BIIB105 does to the body (also called "pharmacodynamics")
- Whether BIIB105 can slow the worsening of clinical function
About BIIB105:
- BIIB105 is an investigational drug designed to reduce the levels of a protein called ATXN2. It is administered intrathecally (via a procedure called lumbar puncture).
Eligibility
Relevant conditions:
Amyotrophic Lateral Sclerosis
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Data sourced from ClinicalTrials.gov