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PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
NCT06961565 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. This study will have two parts, Part A and Part B. The main goal of Part A of this study is to learn more about how participants tolerate different doses of PAS-004, and what side effects PAS-004 might have. What we learn from Part A of the study will help decide what doses of the study drug (PAS-004) should be used in Part B of the study, and if it is safe. In Part B, two different doses from Part A will be tested. The main goal of this part of the study is to keep studying any side effects of PAS-004 at those two dose levels, and to learn more about if the doses picked for this part of the study might have an effect on plexiform neurofibromas. Participants in Part A of the study who were taking doses selected for Part B may be able to continue on to Part B and keep taking the same dose of PAS-004 for 6 more months. Study participants in both parts will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety, including blood draws and MRIs. Everyone participating in the study will take PAS-004 by mouth once a day during the study, in 28-day cycles. Participants will be asked to keep a diary to record their daily dose of study drug. Participants will continue on daily PAS-004 for up to 6 months, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsor selects a dose level to study further in the next part of the study, or * The sponsor stops the study.
Conditions Studied
Interventions
- DRUG PAS-004 Tablets
Study Locations (5)
Other
- Asan Medical Center — Seoul
- Severance Hospital, Yonsei University Health System — Sinchŏn-dong
Alabama
- University of Alabama at Birmingham — Birmingham
New South Wales
- Royal North Shore Hospital — St Leonards
Victoria
- Peter MacCallum Cancer Centre — Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06961565
The ClinicalTrials.gov registry entry for NCT06961565 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pasithea Therapeutics, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Neurofibroma, Plexiform appearing as the primary indexed condition, and to 1 intervention — of which PAS-004 Tablets 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: NCT06961565 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Other, Alabama, New South Wales. 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 NCT06961565 about?
NCT06961565 is a clinical study titled "PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas". The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PA...
What is the current status of trial NCT06961565?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2025-05-30. Estimated completion is 2027-12.
What conditions does trial NCT06961565 study?
This clinical trial studies the following conditions: Neurofibroma, Plexiform, NF1 Mutation, Neurofibromatosis Type 1 (NF1), Neurofibroma Plexiform, Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06961565?
The interventions under investigation include: PAS-004 Tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06961565?
This trial is sponsored by Pasithea Therapeutics, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06961565 being conducted?
This trial has 5 study locations across Alabama, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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