Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome

27 de abril de 2020 actualizado por: Neurocrine Biosciences

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

124

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

  • Estados Unidos
    • California
      • Long Beach, California, Estados Unidos
      • National City, California, Estados Unidos
      • San Bernardino, California, Estados Unidos
      • San Diego, California, Estados Unidos
      • Upland, California, Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos
      • Hialeah, Florida, Estados Unidos
      • Saint Petersburg, Florida, Estados Unidos
      • Tampa, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos
      • Natick, Massachusetts, Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos
    • New Hampshire
      • Nashua, New Hampshire, Estados Unidos
    • New Jersey
      • Summit, New Jersey, Estados Unidos
    • New York
      • Albany, New York, Estados Unidos
      • Manhasset, New York, Estados Unidos
      • New York, New York, Estados Unidos
      • Staten Island, New York, Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
    • Pennsylvania
      • Norristown, Pennsylvania, Estados Unidos
    • Tennessee
      • Nashville, Tennessee, Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos
      • Irving, Texas, Estados Unidos
    • Utah
      • Orem, Utah, Estados Unidos
      • Salt Lake City, Utah, Estados Unidos
    • Washington
      • Kirkland, Washington, Estados Unidos
      • Spokane, Washington, Estados Unidos

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

18 años a 64 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Have a clinical diagnosis of Tourette Syndrome (TS)
  2. Have at least moderate tic severity
  3. Have TS symptoms that impair school, occupational, and/or social function
  4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
  5. Be in good general health
  6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
  7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
  2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia
  3. Have a known history of neuroleptic malignant syndrome
  4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
  5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
  6. Have a known history of substance dependence, substance (drug) or alcohol abuse
  7. Have a significant risk of suicidal or violent behavior
  8. Are currently pregnant or breastfeeding
  9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
  10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
  11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening

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
Comparador de placebos: Placebo
Placebo administered once daily for 8 weeks
Droga: Placebo
Experimental: Dose Group 1
Fixed dose administered once daily for 8 weeks
Droga: NBI-98854
Experimental: Dose Group 2
Fixed dose administered once daily for 8 weeks
Droga: NBI-98854

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to Week 8 in the YGTSS TTS
Periodo de tiempo: Baseline, Week 8
The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview. The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity
Baseline, Week 8

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8
Periodo de tiempo: Week 8
The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale. Each of the CGI-TS-Improvement response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
Week 8
Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score
Periodo de tiempo: Baseline, Week 8
The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale. Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient.
Baseline, Week 8
Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score
Periodo de tiempo: Baseline, Week 8
A modified RTRS was used in this study that includes short video recordings to measure 5 tic variables: number of body areas affected, frequency of motor and phonic tics, and severity of motor and phonic tics. The RTRS total score is calculated as the sum of the 5 domain scores, and ranges from 0 to 20, with higher scores representing greater severity. The final on-treatment visit was used in subjects who discontinued prior to Week 8.
Baseline, Week 8
Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score
Periodo de tiempo: Baseline, Week 8
The YGTSS Global Tic Severity score is the sum of the YGTSS TTS and the YGTSS Impairment score and ranges from 0 to 100, with higher scores representing greater severity.
Baseline, Week 8
Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score
Periodo de tiempo: Baseline, Week 8
The PUTS is an instrument for quantifying the premonitory urge phenomena associated with tics. It consists of 9 items, each of which is scored on a 4-point scale (1=not at all true, 2=a little true, 3=pretty much true, 4=very much true). The PUTS total score is calculated as the sum of the scores for the 9 items. The maximum possible total score is 36.
Baseline, Week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Neurocrine Biosciences

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)

1 de noviembre de 2015

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de octubre de 2015

Publicado por primera vez (Estimar)

21 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NBI-98854-1505

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir