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GABA receptor modulator
Darigabat for Panic Disorder
Phase 2
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 13, and week 14
Awards & highlights
Study Summary
This trial will test if an experimental drug is safe and effective for people with panic disorder.
Who is the study for?
This trial is for adults with a primary diagnosis of panic disorder, having had at least 8 panic attacks in the past month and no week without panic attacks. They must have a certain body weight and BMI, and not be undergoing any new psychotherapy or have significant psychiatric comorbidities or serious health issues.Check my eligibility
What is being tested?
The study tests the effectiveness, safety, and tolerability of darigabat (25 mg twice daily) against a placebo in individuals with panic disorder. Participants will randomly receive either darigabat or placebo to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such trials monitor for adverse reactions like nausea, headaches, dizziness, potential mood changes or other physical symptoms that could arise from taking medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 13, and week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 13, and week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily Diary During Maintenance Treatment Period
Secondary outcome measures
Change from Baseline at all Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Change from Baseline at all Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Change from Baseline at all Time Points up to Week 14 in the PDSS Total Score and Subscores
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DarigabatExperimental Treatment1 Intervention
Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for two weeks in the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks in the Maintenance Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive darigabat matching placebo, orally, BID for 2 weeks during the Titration period and thereafter for 12 weeks during the Maintenance Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darigabat
2023
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,469 Total Patients Enrolled
1 Trials studying Panic Disorder
56 Patients Enrolled for Panic Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major heart, lung, stomach, kidney, liver, blood, immune system, or brain diseases.I have recently started a recognized therapy like CBT.I will undergo therapy based on my exposure levels during the trial.I have been diagnosed with panic disorder.My BMI is between 17.5 and 40, and I weigh more than 48 kg.My BMI is between 17.5 and 40, and I weigh more than 48 kg.In the month before the screening visit, you have had at least 8 panic attacks and no week without a panic attack. In the 2 weeks before the baseline visit, you must have had at least 4 panic attacks and no week without a panic attack.I have been diagnosed with panic disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Darigabat
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widely dispersed is this clinical study within the United States?
"This trial is recruiting from 3 locations in the United States: Phoenix, Arizona; Bryant, Arkansas; and Lafayette California. Additionally, there are 22 other sites participating as well."
Answered by AI
Do I qualify for the requirements of this experiment?
"To be eligible for this research project, individuals should experience panic disorder and must be between 18 to 65 years of age. A total of 228 participants are needed in order for the study to progress."
Answered by AI
Is Darigabat a safe option for patients seeking relief?
"Darigabat's safety was assessed as a 2 on the 1-3 scale, due to limited evidence from Phase 2 trials demonstrating its protective effects."
Answered by AI
Are individuals of at least twenty years age eligible to join this research?
"Eligibility for this clinical trial necessitates that participants must be between eighteen to sixty-five years of age."
Answered by AI
Are individuals still able to register for the experiment?
"Clinicaltrials.gov shows that this medical trial, initially listed on July 1st 2023 and edited lastly on the 10th of the same month, is no longer seeking out patients. Nevertheless, 33 other clinical trials are currently opening its enrolment to participants."
Answered by AI
Who else is applying?
What site did they apply to?
Bryant, Arkansas
Rochester, New York
Other
Torrance, California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried several medications and none of them gave me the results I’m seeking to help with my depression and anxiety.
PatientReceived no prior treatments
I have tried more than 5 medications and nothing has had lasting effectiveness. I am also concerned about building tolerance to current treatments with benzodiazepines.
PatientReceived 1 prior treatment
I am hoping to get some help with my panic disorders. I’ve been dealing with this for a long time medication does not seem to work, and I would like to feel normal and see what it’s like. Thank you.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Will I need to stay in the area for the duration of the trial or is travel back and forth to home possible?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Rochester, New York: < 48 hours
Average response time
- < 2 Days
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