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NCT06100276 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by UniQure Biopharma B.V..
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 12
- Study locations
NCT06100276 is a Phase 1 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by UniQure Biopharma B.V.. The registered enrollment target is 20 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT06100276, a Phase 1 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by UniQure Biopharma B.V..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is the study of AMT-162 in Participants with SOD1-ALS and is designed to evaluate the safety, tolerability, and exploratory efficacy of intrathecally administered gene therapy AMT-162. AMT-162-001 is a Phase 1/2, multi-center, single ascending dose study.
Conditions Studied
Interventions
- DRUG AMT-162
Study Locations (12)
California
- University of California Irvine - Irvine
- California Pacific Medical Center - San Francisco
Arizona
- Barrow Neurological Institute - Phoenix
Florida
- Mayo Clinic Florida - Jacksonville
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Kansas
- University of Kansas Medical Center - Fairway
Massachusetts
- Massachusetts General Hospital, Sean M. Healey and AMG Center for ALS Research - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06100276
The ClinicalTrials.gov registry entry for NCT06100276 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is UniQure Biopharma B.V., which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which AMT-162 is the first listed.
NCT06100276 reports 12 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06100276 about?
NCT06100276 is a clinical study titled "Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)". This is the study of AMT-162 in Participants with SOD1-ALS and is designed to evaluate the safety, tolerability, and exploratory efficacy of intrathecally administered gene therapy AMT-162. AMT-162-001 is a Phase 1/2, multi-center, single ascending dose study.
What is the current status of trial NCT06100276?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-08-01. Estimated completion is 2031-06-30.
What conditions does trial NCT06100276 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT06100276?
The interventions under investigation include: AMT-162 (DRUG).
Who is sponsoring clinical trial NCT06100276?
This trial is sponsored by UniQure Biopharma B.V., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100276 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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