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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