Un estudio para evaluar la eficacia, la seguridad y la tolerabilidad de Darigabat en participantes con trastorno de pánico
16 de abril de 2026 actualizado por: AbbVie
Un ensayo de fase 2, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia, la seguridad y la tolerabilidad de darigabat en participantes con trastorno de pánico
El propósito de este ensayo es medir la eficacia, la seguridad y la tolerabilidad de darigabat (25 miligramos [mg] dos veces al día [BID]) en comparación con el placebo en participantes con trastorno de pánico.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85012
- Phoenix, Arizona
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California
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Lafayette, California, Estados Unidos, 94549
- Lafayette, California
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Los Angeles, California, Estados Unidos, 90025
- Los Angeles, California
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Oceanside, California, Estados Unidos, 92056
- Oceanside, California
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Orange, California, Estados Unidos, 92868
- Orange, California
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Riverside, California, Estados Unidos, 92506
- Riverside, California
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San Jose, California, Estados Unidos, 95124
- San Jose, California
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Torrance, California, Estados Unidos, 90502
- Torrance, California
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Florida
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Miami, Florida, Estados Unidos, 33175
- Miami, Florida
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North Miami Beach, Florida, Estados Unidos, 33162
- North Miami Beach, Florida
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Orlando, Florida, Estados Unidos, 32807
- Orlando, Florida
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Georgia
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Atlanta, Georgia, Estados Unidos, 30331
- Atlanta, Georgia
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Decatur, Georgia, Estados Unidos, 30030
- Decatur, Georgia
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Savannah, Georgia, Estados Unidos, 31405
- Savannah, Georgia
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Illinois
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Elgin, Illinois, Estados Unidos, 60123
- Elgin, Illinois
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210
- Overland Park, Kansas
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02131
- Boston, Massachusetts
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- Las Vegas, Nevada
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New Jersey
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Berlin, New Jersey, Estados Unidos, 08009
- Berlin, New Jersey
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New York
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Brooklyn, New York, Estados Unidos, 11229
- Brooklyn, New York
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Brooklyn, New York, Estados Unidos, 11235
- Brooklyn, New York
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New York, New York, Estados Unidos, 10016
- New York, New York
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Rochester, New York, Estados Unidos, 14618
- Rochester, New York
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Staten Island, New York, Estados Unidos, 10314
- Staten Island, New York
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North Carolina
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Monroe, North Carolina, Estados Unidos, 28112
- Monroe, North Carolina
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Oklahoma City, Oklahoma
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Pennsylvania
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West Chester, Pennsylvania, Estados Unidos, 19380
- West Chester, Pennsylvania
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Texas
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Austin, Texas, Estados Unidos, 78737
- Austin, Texas
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DeSoto, Texas, Estados Unidos, 75115
- DeSoto, Texas
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Utah
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Draper, Utah, Estados Unidos, 84020
- Draper, Utah
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Washington
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Everett, Washington, Estados Unidos, 98201
- Everett, Washington
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Diagnóstico primario de trastorno de pánico basado en el Manual Diagnóstico y Estadístico de los Trastornos Mentales, Revisión del Texto de la Quinta Edición (DSM-5-TR), según lo confirmado por la Mini Entrevista Neuropsiquiátrica Internacional (MINI) para Trastornos Psicóticos
- El participante ha tenido un mínimo de 8 ataques de pánico, sin semana libre de ataques de pánico, en el mes anterior a la visita de selección. En las 2 semanas anteriores a la visita inicial, el participante debe haber tenido al menos 4 ataques de pánico y ninguna semana sin ataques de pánico.
- Participantes con una puntuación total de PDSS ≥12 en las visitas de selección y de referencia
- Índice de masa corporal de 17,5 a 40,0 kilogramos por metro cuadrado (kg/m2) y peso corporal total >48 kg en la selección
Criterio de exclusión:
- Participantes que tienen una comorbilidad psiquiátrica significativa actual
- Cualquier psicoterapia basada en la evidencia recién iniciada, incluida la terapia cognitiva conductual (TCC)
- Cualquier terapia basada en la exposición está prohibida durante la duración del ensayo.
- Participantes con antecedentes actuales de enfermedades cardiovasculares, pulmonares, gastrointestinales, renales, hepáticas, metabólicas, hematológicas, inmunológicas o neurológicas significativas
Participantes que respondieron "Sí" en los siguientes ítems de ideación suicida de la C-SSRS (en los últimos 6 meses)
- Ideación suicida Ítem 4 (Ideación suicida activa con alguna intención de actuar, sin plan específico) O
- Ítem 5 de Ideación Suicida (Ideación Suicida Activa con Plan e Intención Específicos) O Participantes que respondieron "Sí" en cualquiera de los 5 ítems de Comportamiento Suicida de la C-SSRS (en los últimos 2 años)
- Cualquiera de los elementos de comportamiento suicida (intento real, intento interrumpido, intento abortado, actos preparatorios o comportamiento) O
- Participantes que, a juicio del investigador, presenten un riesgo grave de suicidio
NOTA: Es posible que se apliquen otros criterios de inclusión/exclusión definidos por el protocolo
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Tabletas orales
Otros nombres:
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Comparador de placebos: 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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Tabletas orales
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de julio de 2023
Finalización primaria (Actual)
31 de marzo de 2025
Finalización del estudio (Actual)
31 de marzo de 2025
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2023
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2023
Publicado por primera vez (Actual)
12 de julio de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CVL-865-PA-2001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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