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NCT04714359 · ClinicalTrials.gov registry record · Phase 3
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
A Phase 3 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT04714359: Completed Phase 3 study, sponsored by Resilient Pharmaceuticals.
NCT04714359 is a Phase 3 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04714359, a Phase 3 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.
Interventions
- DRUG Midomafetamine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04714359
The ClinicalTrials.gov registry entry for NCT04714359 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Midomafetamine HCl is the first listed.
NCT04714359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04714359 about?
NCT04714359 is a clinical study titled "A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible d...
What is the current status of trial NCT04714359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2021-03-08. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT04714359?
The interventions under investigation include: Midomafetamine HCl (DRUG).
Who is sponsoring clinical trial NCT04714359?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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