CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
CVL-865 High dose +3 moredrug
Likely dose
Alprazolam 1mg XRfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04592536
NCT04592536Phase 1Completed

A Randomized, Double-blind, Placebo- and Active Comparator-controlled, Crossover Trial to Examine the Effect of Multiple Doses of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subject

Cerevel Therapeutics, LLC·interventional·Posted Oct 19, 2020·Updated Jan 11, 2022

In Brief

A Phase 1 clinical trial evaluating CVL-865 High dose, Alprazolam 1mg XR, and 2 other interventions for Panic Disorder. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPanic Disorder
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartOct 6, 2020
Primary CompletionNov 14, 2021
Study CompletionDec 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

CVL-865 High dosedrug

High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)

Alprazolam 1mg XRdrug

Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)

Placebodrug

Placebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)

CVL-865 low dosedrug

Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)