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A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT05039099 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AL-S Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05039099 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Other, Ontario, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05039099?
The interventions under investigation include: Placebo (DRUG), AP-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05039099?
This trial is sponsored by AL-S Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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