En undersøgelse for at evaluere effektivitet, sikkerhed og tolerabilitet af Darigabat hos deltagere med panikangst
Et fase 2, randomiseret, dobbeltblindt, placebokontrolleret forsøg til evaluering af Darigabats effektivitet, sikkerhed og tolerabilitet hos deltagere med panikangst
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- Phoenix, Arizona
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California
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Lafayette, California, Forenede Stater, 94549
- Lafayette, California
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Los Angeles, California, Forenede Stater, 90025
- Los Angeles, California
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Oceanside, California, Forenede Stater, 92056
- Oceanside, California
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Orange, California, Forenede Stater, 92868
- Orange, California
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Riverside, California, Forenede Stater, 92506
- Riverside, California
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San Jose, California, Forenede Stater, 95124
- San Jose, California
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Torrance, California, Forenede Stater, 90502
- Torrance, California
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Florida
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Miami, Florida, Forenede Stater, 33175
- Miami, Florida
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North Miami Beach, Florida, Forenede Stater, 33162
- North Miami Beach, Florida
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Orlando, Florida, Forenede Stater, 32807
- Orlando, Florida
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Georgia
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Atlanta, Georgia, Forenede Stater, 30331
- Atlanta, Georgia
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Decatur, Georgia, Forenede Stater, 30030
- Decatur, Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Savannah, Georgia
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Illinois
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Elgin, Illinois, Forenede Stater, 60123
- Elgin, Illinois
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Overland Park, Kansas
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Boston, Massachusetts
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- Las Vegas, Nevada
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New Jersey
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Berlin, New Jersey, Forenede Stater, 08009
- Berlin, New Jersey
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New York
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Brooklyn, New York, Forenede Stater, 11229
- Brooklyn, New York
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Brooklyn, New York, Forenede Stater, 11235
- Brooklyn, New York
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New York, New York, Forenede Stater, 10016
- New York, New York
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Rochester, New York, Forenede Stater, 14618
- Rochester, New York
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Staten Island, New York, Forenede Stater, 10314
- Staten Island, New York
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North Carolina
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Monroe, North Carolina, Forenede Stater, 28112
- Monroe, North Carolina
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Oklahoma City, Oklahoma
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Pennsylvania
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West Chester, Pennsylvania, Forenede Stater, 19380
- West Chester, Pennsylvania
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Texas
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Austin, Texas, Forenede Stater, 78737
- Austin, Texas
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DeSoto, Texas, Forenede Stater, 75115
- DeSoto, Texas
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Utah
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Draper, Utah, Forenede Stater, 84020
- Draper, Utah
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Washington
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Everett, Washington, Forenede Stater, 98201
- Everett, Washington
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Primær diagnose af panikangst baseret på Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), som bekræftet af Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders
- Deltageren har haft minimum 8 panikanfald uden en uge fri for panikanfald i måneden forud for screeningsbesøget. I de 2 uger forud for baselinebesøget skal deltageren have haft mindst 4 panikanfald og ingen uge fri for panikanfald
- Deltagere med en samlet PDSS-score ≥12 ved screenings- og baselinebesøgene
- Kropsmasseindeks på 17,5 til 40,0 kg pr. kvadratmeter (kg/m2) og en samlet kropsvægt >48 kg ved screening
Ekskluderingskriterier:
- Deltagere, der har en aktuel betydelig psykiatrisk komorbiditet
- Enhver nystartet evidensbaseret psykoterapi, herunder kognitiv adfærdsterapi (CBT)
- Enhver eksponeringsbaseret terapi er forbudt i hele forsøgets varighed
- Deltagere med en aktuel historie med betydelig kardiovaskulær, pulmonal, gastrointestinal, nyre-, lever-, metabolisk, hæmatologisk, immunologisk eller neurologisk sygdom
Deltagere, der svarer "Ja" på følgende C-SSRS selvmordstanker (inden for de sidste 6 måneder)
- Selvmordstanker Punkt 4 (Aktiv selvmordstanker med en vis hensigt om at handle, uden specifik plan) ELLER
- Selvmordstanker Punkt 5 (Aktiv selvmordstanker med specifik plan og hensigt) ELLER Deltagere, der svarer "Ja" på en af de 5 C-SSRS selvmordsadfærdspunkter (inden for de sidste 2 år)
- Enhver af selvmordsadfærden (faktisk forsøg, afbrudt forsøg, afbrudt forsøg, forberedende handlinger eller adfærd) ELLER
- Deltagere, der efter efterforskerens opfattelse udgør en alvorlig risiko for selvmord
BEMÆRK: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Darigabat
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.
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Orale tabletter
Andre navne:
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Placebo komparator: Placebo
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.
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Orale tabletter
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily eDiary During the Last Two Weeks of the Maintenance Treatment Period
Tidsramme: Week 13-14
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Numerator is the number of participants in the period who were panic free and had no fewer that 12 eDiary entries.
Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries.
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Week 13-14
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
Tidsramme: Week 14 (Day 98)
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The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity.
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Week 14 (Day 98)
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Change From Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period
Tidsramme: Week 13-14
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Panic attack frequency is defined as the total number of panic attacks over each two-week interval divided by the total number of days the eDiary was completed in the same analysis period multiplied by 14. Participants with a minimum of 7 completed diary days in a two-week interval will be considered for panic attack frequency, otherwise will be considered missing.
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Week 13-14
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Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Tidsramme: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)
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Numerator is the number of participants who were panic free and had no fewer than 12 eDiary entries in the corresponding time period. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries. * Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion. |
Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)
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Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score
Tidsramme: Baseline through Week 14
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The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group |
Baseline through Week 14
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Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Tidsramme: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)
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Panic attack frequency is defined as the total number of panic attacks over each two-week interval divided by the total number of days the eDiary was completed in the same analysis period multiplied by 14. Participants with a minimum of 7 completed diary days in a two-week interval will be considered for panic attack frequency, otherwise will be considered missing. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group * Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion. |
Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)
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Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Tidsramme: Baseline through Week 14
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The Clinical Global Impression-Severity (CGI-S) scale is a single item 7-point scale, with panic order severity rated from 1 (normal) through to 7 (most severely ill). Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group. |
Baseline through Week 14
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Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Tidsramme: Baseline through Week 14
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The Hamilton Anxiety Scale (HAM-A) is a 14-item scale measures severity of anxiety symptoms. Each item is scored on a scale from 0 (not present) to 4 (severe) resulting in a total score range of 0 to 56, with higher scores indicating more severe anxiety. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group. |
Baseline through Week 14
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: From Day 1 through Week 18
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A Treatment-Emergent Adverse Event (TEAE) is any event reported on the CRF that occurs on or after the initiation of IMP and through follow-up contact.
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From Day 1 through Week 18
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Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Tidsramme: Up to Week 14
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12-lead ECGs recordings were obtained after the participant had been supine and at rest for at least 3 minutes.
The number of participants with significant abnormalities is reported by 'change from baseline in QT interval as corrected for heart rate by Fridericia's formula (QTcF)'.
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Up to Week 14
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Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessment Values
Tidsramme: Up to Week 18
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Protocol-required safety laboratory tests were performed, including hematology, chemistry and urinalysis tests.
Reported here is the number of participants with clinically significant changes in these laboratory tests.
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Up to Week 18
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Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Tidsramme: Up to Week 14
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Vital signs were measured with the participant in a sitting/semi-recumbent position after 3 minutes rest and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate.
Reported here is the number of participants with clinically significant changes in vital sign measurements.
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Up to Week 14
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Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Tidsramme: Up to Week 14
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A complete physical examination consisted of measurement of weight and a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart, lungs, lymph nodes, and gastrointestinal, genitourinary, and musculoskeletal systems.
A full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength, and reflexes), sensation (including Romberg sign), coordination, and gait.
Reported here is the number of participants with clinically significant changes in physical or neurological examination results.
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Up to Week 14
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Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Week 14
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The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide.
C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Reported here is the number of participants with changes in suicidality assessed using the C-SSRS scale.
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Up to Week 14
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Number of Participants With Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)
Tidsramme: Up to Week 15
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The PWC is a 20-item scale to measure discontinuation symptoms after stopping a medication for anxiety disorders.
All 20 items are rated on a 4-point numeric-rating scale ranging from 0 (not present), 1 (mild), 2 (moderate), to 3 (severe).
A total score, ranging 0 to 60, was calculated in addition to the individual scores for each item.
Lower scores indicate less severity in discontinuation symptoms.
Reported here is the number of participants with withdrawal symptoms assessed using the PWC.
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Up to Week 15
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CVL-865-PA-2001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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