Frontlight ResearchEarly access
TerminatedPhase 2
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
Key facts
- Who runs it
- AbbVie
- Where
- Atlanta, Austin, Berlin, Boston, Brooklyn, Decatur, DeSoto, Draper, Elgin, Everett, Lafayette, Las Vegas, Los Angeles, Miami, Monroe, New York, North Miami Beach, Oceanside, Oklahoma City, Orange, Orlando, Overland Park, Phoenix, Riverside, Rochester, San Jose, Savannah, Staten Island, Torrance, and West Chester, United StatesSee the 30 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 80 people enrolled
- Started
- 31 Jul 2023
- Ended
- 31 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Darigabat
- Placebo
- Record updated
- 7 May 2026
- Why it stopped
- Sponsor terminated due to significant enrollment and study design challenges
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by the Standard Mini International Neuropsychiatric Interview (MINI)
- Participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the Screening Visit. In the 2 weeks prior to the Baseline Visit, the participant must have had at least 4 panic attacks and no week free of panic attacks
- Participants with a PDSS total score ≥12 at the Screening and Baseline Visits
- Body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total body weight >48 kg at Screening
Who cannot take part
- Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (CBT)
- Any exposure-based therapy is prohibited throughout the duration of the trial
- Participants who have a current significant psychiatric comorbidity
- Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease
- Participants who answer "Yes" on the following C-SSRS Suicidal Ideation Items (within the last 6 months); Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) OR; Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (within the last 2 years); Any of the Suicidal Behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) OR; Participants who, in the opinion of the investigator, present a serious risk of suicide; NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Where in United States
- Atlanta, GeorgiaAtlanta, United States
- Austin, TexasAustin, United States
- Berlin, New JerseyBerlin, United States
- Boston, MassachusettsBoston, United States
- Brooklyn, New YorkBrooklyn, United States
- Decatur, GeorgiaDecatur, United States
- DeSoto, TexasDeSoto, United States
- Draper, UtahDraper, United States
- Elgin, IllinoisElgin, United States
- Everett, WashingtonEverett, United States
- Lafayette, CaliforniaLafayette, United States
- Las Vegas, NevadaLas Vegas, United States
- Los Angeles, CaliforniaLos Angeles, United States
- Miami, FloridaMiami, United States
- Monroe, North CarolinaMonroe, United States
- New York, New YorkNew York, United States
- North Miami Beach, FloridaNorth Miami Beach, United States
- Oceanside, CaliforniaOceanside, United States
- Oklahoma City, OklahomaOklahoma City, United States
- Orange, CaliforniaOrange, United States
- Orlando, FloridaOrlando, United States
- Overland Park, KansasOverland Park, United States
- Phoenix, ArizonaPhoenix, United States
- Riverside, CaliforniaRiverside, United States
- Rochester, New YorkRochester, United States
- San Jose, CaliforniaSan Jose, United States
- Savannah, GeorgiaSavannah, United States
- Staten Island, New YorkStaten Island, United States
- Torrance, CaliforniaTorrance, United States
- West Chester, PennsylvaniaWest Chester, United States
About the trial
What the trial wants to find out
The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams [mg] twice daily [BID]) compared with placebo in participants with panic disorder.
The 2 groups in the trial
- DarigabatTreatment being tested
Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
- PlaceboPlacebo, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
- Record updated
- 7 May 2026