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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: Completed Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by AL-S Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. SAE is defined as any untowa
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 |
What the finished NCT05039099 record still lists
NCT05039099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower).
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 lists 13 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05039099's enrollment target sits among peer trials
73 49th of 102 higher than 54 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis 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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