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NCT04494256 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT04494256: Clinical Trial Phase 1 study, sponsored by Biogen.
NCT04494256 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04494256, a Phase 1 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study 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
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a conge
Interventions
- DRUG Placebo
- DRUG BIIB105
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2024-08-13 |
| Phase | Phase 1 |
Why NCT04494256 stopped before completion
NCT04494256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04494256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04494256 about?
NCT04494256 is a clinical study titled "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 BIIB...
What is the current status of trial NCT04494256?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2020-09-28. Estimated completion is 2024-08-13.
What interventions are being tested in trial NCT04494256?
The interventions under investigation include: Placebo (DRUG), BIIB105 (DRUG).
Who is sponsoring clinical trial NCT04494256?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04494256's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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