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NCT05039099 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by AL-S Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
- 13
- Study locations
NCT05039099 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by AL-S Pharma. The registered enrollment target is 73 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower). The trial reports 13 study locations across 10 states.
The verdict
NCT05039099, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by AL-S Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AP-101
Study Locations (13)
Other
- Department of Neurology, University Hospitals - Leuven
- Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE) - Bonn
- Norrlands universitetssjukhus/ University Hospital of Northern Sweden (NUS) - Umeå
Ontario
- London Health Sciences Centre - Victoria Hospital - London
- ALS Research Sunnybrook Health Sciences Centre - Toronto
California
- UC San Diego, ACTRI - La Jolla
Alberta
- ALS clinic at the Kaye Edmonton Clinic, University of Alberta - Edmonton
Quebec
- Montreal Neurological Institute and Hospital / Dr Genge - Montreal
Hanover
- Hannover Medical School - Hanover
State of Berlin
- Charité - Berlin
Ulm
- Ulm University Hospital - Ulm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2025-08-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05039099
The ClinicalTrials.gov registry entry for NCT05039099 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower). The listed sponsor is AL-S Pharma, which has 1 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 2 interventions - of which Placebo is the first listed.
NCT05039099 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Other, Ontario, California.
Frequently Asked Questions
What is clinical trial NCT05039099 about?
NCT05039099 is a clinical study titled "A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)". The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
What is the current status of trial NCT05039099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2021-09-02. Estimated completion is 2025-08-13.
What conditions does trial NCT05039099 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT05039099?
The interventions under investigation include: Placebo (DRUG), AP-101 (DRUG).
Who is sponsoring clinical trial NCT05039099?
This trial is sponsored by AL-S Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05039099 being conducted?
This trial has 13 study locations across California, Alberta, Ontario, Quebec, Hanover. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.