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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

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 weeks
Treatment ~ Varies
Follow Up ~baseline, week 13, and week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 13, and week 14 for reporting.

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 more

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Panic Disorder treatments often target neurotransmitter systems to alleviate symptoms. Darigabat, like other GABA-A receptor modulators, enhances the inhibitory effects of GABA, the brain's primary inhibitory neurotransmitter, which helps reduce neuronal excitability and anxiety. This mechanism is crucial for Panic Disorder patients as it can help prevent the sudden onset of panic attacks. Additionally, SSRIs and SNRIs, which are commonly used, increase serotonin and norepinephrine levels, respectively, to improve mood and reduce anxiety. Understanding these mechanisms helps in selecting appropriate treatments tailored to individual patient needs, potentially improving outcomes and quality of life.

Find a Location

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
36 Previous Clinical Trials
5,466 Total Patients Enrolled
1 Trials studying Panic Disorder
56 Patients Enrolled for Panic Disorder

Media Library

Darigabat (GABA receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05941442 — Phase 2
Panic Disorder Research Study Groups: Darigabat, Placebo
Panic Disorder Clinical Trial 2023: Darigabat Highlights & Side Effects. Trial Name: NCT05941442 — Phase 2
Darigabat (GABA receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05941442 — Phase 2
~91 spots leftby Mar 2025