Um estudo para avaliar a eficácia, segurança e tolerabilidade de Darigabat em participantes com transtorno de pânico
Um estudo de fase 2, randomizado, duplo-cego, controlado por placebo para avaliar a eficácia, segurança e tolerabilidade do darigabat em participantes com transtorno do pânico
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- Diagnóstico primário de transtorno do pânico com base no Manual Diagnóstico e Estatístico de Transtornos Mentais, Revisão de Texto da Quinta Edição (DSM-5-TR), conforme confirmado pela Mini Entrevista Neuropsiquiátrica Internacional (MINI) para Transtornos Psicóticos
- O participante teve um mínimo de 8 ataques de pânico, sem nenhuma semana livre de ataques de pânico, no mês anterior à visita de triagem. Nas 2 semanas anteriores à visita de linha de base, o participante deve ter tido pelo menos 4 ataques de pânico e nenhuma semana livre de ataques de pânico
- Participantes com uma pontuação total de PDSS ≥12 nas visitas de triagem e linha de base
- Índice de massa corporal de 17,5 a 40,0 quilos por metro quadrado (kg/m2) e peso corporal total >48 kg na triagem
Critério de exclusão:
- Participantes que têm uma comorbidade psiquiátrica significativa atual
- Qualquer psicoterapia baseada em evidências recém-iniciada, incluindo terapia cognitivo-comportamental (TCC)
- Qualquer terapia baseada em exposição é proibida durante a duração do teste
- Participantes com história atual de doença cardiovascular, pulmonar, gastrointestinal, renal, hepática, metabólica, hematológica, imunológica ou neurológica significativa
Participantes que responderam "Sim" nos seguintes Itens de Ideação Suicida do C-SSRS (nos últimos 6 meses)
- Ideação Suicida Item 4 (Ideação Suicida Ativa com Alguma Intenção de Agir, Sem Plano Específico) OU
- Item 5 de Ideação Suicida (Ideação Suicida Ativa com Plano e Intenção Específicos) OU Participantes que responderem "Sim" em qualquer um dos 5 Itens de Comportamento Suicida do C-SSRS (nos últimos 2 anos)
- Qualquer um dos itens de Comportamento Suicida (tentativa real, tentativa interrompida, tentativa abortada, atos preparatórios ou comportamento) OU
- Participantes que, na opinião do investigador, apresentam sério risco de suicídio
NOTA: Outros critérios de inclusão/exclusão definidos pelo protocolo podem ser aplicados
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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Comprimidos orais
Outros nomes:
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Comparador de Placebo: 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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Comprimidos orais
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Patrocinador
Investigadores
- Diretor de estudo: ABBVIE INC., AbbVie
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CVL-865-PA-2001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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