Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04494256
Brief Summary:
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
Detailed Description:
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).
Study:
NCT04494256
Study Brief:
Protocol Section:
NCT04494256