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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 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 99 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04494256
The ClinicalTrials.gov registry entry for NCT04494256 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04494256 reports 0 study locations.
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.
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