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NCT04295642 · ClinicalTrials.gov registry record · Phase 1
A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
A Phase 1 study, sponsored by Cerevel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04295642 is a Phase 1 study that has completed, run by Cerevel Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT04295642, a Phase 1 study, has completed, sponsored by Cerevel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a 15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part 1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours post-Day 1 dose).
Interventions
- DRUG CVL-751
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04295642
The ClinicalTrials.gov registry entry for NCT04295642 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cerevel Therapeutics, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CVL-751 is the first listed.
NCT04295642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04295642 about?
NCT04295642 is a clinical study titled "A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease". This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In case of intolerable ...
What is the current status of trial NCT04295642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-01-08. Estimated completion is 2021-07-23.
What interventions are being tested in trial NCT04295642?
The interventions under investigation include: CVL-751 (DRUG).
Who is sponsoring clinical trial NCT04295642?
This trial is sponsored by Cerevel Therapeutics, which has 21 total clinical trials registered on ClinicalTrials.gov.
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