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NCT07294144 · ClinicalTrials.gov registry record · Phase 2
Tofersen in Non-SOD1 ALS
A Phase 2 study of ALS (Amyotrophic Lateral Sclerosis), sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07294144: Recruiting Phase 2 study of ALS (Amyotrophic Lateral Sclerosis), sponsored by Washington University School of Medicine.
NCT07294144 is a Phase 2 study of ALS (Amyotrophic Lateral Sclerosis) that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 30 participants, below the 363-participant average among 6 other ALS (Amyotrophic Lateral Sclerosis) trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07294144, a Phase 2 study of ALS (Amyotrophic Lateral Sclerosis), is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate whether tofersen is safe and effective in adults with non-SOD1 ALS. Tofersen is currently approved by the U.S. Food and Drug Administration to treat SOD1-ALS. The main questions it aims to answer are: * Does tofersen lower the levels of neurofilament light chain (NfL) in the blood and CSF of adult participants with non-SOD1 ALS? * Is tofersen safe and tolerable for adult participants with non-SOD1 ALS? * Does tofersen affect other measurements such as clinical outcomes and quality-of-life measures in participants with non-SOD1 ALS? Participants will : * Receive 100mg tofersen via lumbar puncture for 24 weeks. The doses are at the following time points: Weeks 0, 2, 4, 8, 12, 16, 20, and 24. * Complete 2 follow-up visits following the end of the dosing period at Weeks 28 and 32. * Complete a variety of questionnaires and outcome measurements such as strength and breathing testing.
Conditions Studied
Interventions
- DRUG Tofersen
Study Locations (1)
Missouri
- Washington University ALS Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-12-29 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT07294144 shows while recruiting
NCT07294144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 363-participant average among 6 other ALS (Amyotrophic Lateral Sclerosis) trials with a reported enrollment target (92% lower).
The record links to 1 condition, with ALS (Amyotrophic Lateral Sclerosis) appearing as the primary indexed condition, and to 1 intervention - of which Tofersen is the first listed.
NCT07294144 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT07294144 about?
NCT07294144 is a clinical study titled "Tofersen in Non-SOD1 ALS". The goal of this clinical trial is to evaluate whether tofersen is safe and effective in adults with non-SOD1 ALS. Tofersen is currently approved by the U.S. Food and Drug Administration to treat SOD1-ALS. The main questions it aims to answer are: * Does tofersen lower the levels of neurofilament l...
What is the current status of trial NCT07294144?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-12-29. Estimated completion is 2028-05.
What conditions does trial NCT07294144 study?
This clinical trial studies the following conditions: ALS (Amyotrophic Lateral Sclerosis).
What interventions are being tested in trial NCT07294144?
The interventions under investigation include: Tofersen (DRUG).
Who is sponsoring clinical trial NCT07294144?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07294144 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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