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A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients

17 de febrero de 2022 actualizado por: Takeda

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa

The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early Parkinson's disease.

The study period consisted of a 28-week trial period. The participants who fulfill the inclusion criteria and not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1 ratio to either the 1 mg of TVP-1012 or the placebo group. In each treatment group, participants received either 1 mg of TVP-1012 or placebo once daily in a double-blinded manner.

Tipo de estudio

Intervencionista

Inscripción (Actual)

244

Fase

  • Fase 3

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

  • Japón
      • Akita, Japón
      • Aomori, Japón
      • Fukuoka, Japón
      • Fukushima, Japón
      • Hiroshima, Japón
      • Kochi, Japón
      • Kyoto, Japón
      • Niigata, Japón
      • Okayama, Japón
      • Osaka, Japón
      • Tokushima, Japón
      • Toyama, Japón
      • Wakayama, Japón
      • Yamagata, Japón
    • Aichi
      • Nagoya, Aichi, Japón
    • Ehime
      • Matsuyama, Ehime, Japón
      • Touon, Ehime, Japón
    • Fukuoka
      • Kitakyushu, Fukuoka, Japón
      • Onoshiro, Fukuoka, Japón
    • Hokkaido
      • Asahikawa, Hokkaido, Japón
      • Iwamizawa, Hokkaido, Japón
    • Hyogo
      • Akashi, Hyogo, Japón
      • Kobe, Hyogo, Japón
    • Ibaragi
      • Tsuchiura, Ibaragi, Japón
      • Tsukuba, Ibaragi, Japón
    • Iwate
      • Morioka, Iwate, Japón
    • Kagawa
      • Takamatsu, Kagawa, Japón
    • Kanagawa
      • Fujisawa, Kanagawa, Japón
      • Sagamihara, Kanagawa, Japón
      • Yokohama, Kanagawa, Japón
    • Kumamoto
      • Goushi, Kumamoto, Japón
    • Miyagi
      • Sendai, Miyagi, Japón
    • Nagano
      • Matsumoto, Nagano, Japón
    • Nagasaki
      • Higashisonogi-gun, Nagasaki, Japón
      • Nishisonogi-gun, Nagasaki, Japón
    • Nara
      • Tenri, Nara, Japón
    • Niigata
      • Jouetsu, Niigata, Japón
    • Osaka
      • Higashiosaka, Osaka, Japón
      • Suita, Osaka, Japón
      • Takatsuki, Osaka, Japón
      • Toyonaka, Osaka, Japón
    • Saitama
      • Irima-gun, Saitama, Japón
    • Shizuoka
      • Fuji, Shizuoka, Japón
      • Hamamatsu, Shizuoka, Japón
      • Izunokuni, Shizuoka, Japón
    • Tochigi
      • Shimono, Tochigi, Japón
    • Tokushima
      • Yoshinogawa, Tokushima, Japón
    • Tokyo
      • Bunkyo-ku, Tokyo, Japón
      • Fuchu, Tokyo, Japón
      • Kodaira, Tokyo, Japón
      • Meguro-ku, Tokyo, Japón
      • Nerima-ku, Tokyo, Japón
      • Ota-ku, Tokyo, Japón
      • Setagaya-ku, Tokyo, Japón
      • Shibuya-ku, Tokyo, Japón

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

30 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Run-in period

  • In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • The participant has a diagnosis of Parkinson's disease with at least two of the following signs: resting tremor, akinesia/bradykinesia, and muscle rigidity.
  • The participant has a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score of >=14 at the start of the run-in period.
  • The participant has Modified Hoehn & Yahr stage 1 to 3 at the start of the run-in period.
  • The participant has the Parkinson's disease diagnosed within 5 years prior to the start of the run-in period.
  • The participant is an outpatient of either sex aged >= 30 and < 80 years.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to 1 month after the last dose of the investigational drug.

Treatment period

- The participant has a MDS-UPDRS Part II + Part III total score of >= 14 at baseline.

Exclusion Criteria:

Run-in period

  • The participant has received any investigational medication within 90 days prior to the start of the run-in period.
  • The participant has received TVP-1012 in the past.
  • The participant is study site employee, an immediate family member, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
  • Participant has donated 400 mL or more of his or her blood volume within 90 days prior to the start of the run-in period.
  • The participant has unstable systemic disease.
  • The participant has Mini-Mental State Examination (MMSE) score of <= 24 at the start of the run-in period.
  • The participant has known or a history of schizophrenia, major or severe depression, or any other clinically significant psychiatric disease.
  • The participant has a history of hypersensitivity or allergies to TVP-1012 (including any associated excipients) or selegiline.
  • The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever, herring, yeast, horsebean, banana, beer or wine).
  • The participant has a history or concurrent of drug abuse or alcohol dependence.
  • The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
  • The participant has received transcranial magnetic stimulation within 6 months prior to the start of the run-in period
  • The participant has received amantadine or anticholinergic medication for >= 180 days.
  • The participant has received selegiline, a levodopa-containing product or dopamine agonist for >= 90 days.
  • The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days prior to the start of the run-in period.
  • The participant has received a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days prior to the start of the run-in period.
  • The participant has received any psychoneurotic agent or antiemetic medication of dopamine antagonist within 14 days prior to the start of the run-in period. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days prior to the start of the run-in period may be included in the study.
  • The participant has previously received a catechol-O-methyltransferase (COMT) inhibitor, droxidopa, zonisamide or istradefylline.
  • The participant is required to take any of the prohibited concomitant medications or treatments.
  • If female, the participant is pregnant or lactating or intending to become pregnant during this study, or within 1 month after the last dose of the investigational drug; or intending to donate ova during such time period.
  • The participant has clinically significant neurologic, cardiovascular, pulmonary, hepatic (including mild cirrhosis), renal, metabolic, gastrointestinal, urological, endocrine, or hematological disease.

  • The participant has clinically significant or unstable brain or cardiovascular disease, such as:

    • clinically significant arrhythmia or cardiac valvulopathy,
    • cardiac arrest of NYHA Class II or higher,
    • concurrent or a history of ischemic cardiac disease within 6 months prior to the start of the run-in period,
    • concurrent or a history of clinically significant cerebrovascular disease within 6 months prior to the start of the run-in period,
    • sever hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher),
    • clinically significant orthostatic hypotension (including those with systolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position),
    • a history of syncope due to hypotension within 2 years prior to the start of the run-in period.
  • The participant is required surgery or hospitalization for surgery during the study period
  • Participant has a history of cancer within 5 years prior to the start of the run-in period, except cervix carcinoma in situ which has completely cured.
  • The participant has acquired immunodeficiency syndrome (AIDS) [including human immunodeficiency virus (HIV) carrier], or hepatitis [including viral hepatitis carrier such as hepatitis B surface (HBs) antigen or hepatitis C antibody (HCV) positive]. However, the participant who has a negative result for HCV antigen or HCV-RNA can be included in the study.
  • The participant who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason.

Treatment period

  • The participant whose diagonosis of Parkinson's disease is ruled out by dopamine transporter scintigraphy performed during the run-in period if conducted.

  • The participant has laboratory data meeting any of the following at the start of the run-in period:

    • Creatinine >= 2 x upper limit of normal (ULN)
    • Total bilirubin >= 2 x ULN
    • ALT or AST >= 1.5 x ULN
    • ALP >= 3 x ULN
  • The participant has received any of the prohibited concomitant medications or treatments during the run-in period.

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
Experimental: TVP-1012 1 mg
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
Droga: TVP-1012
TVP-1012 1mg Tablets
Comparador de placebos: Placebo
For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
Droga: Placebo
Tabletas de placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
Periodo de tiempo: From Baseline to Week 26 (LOCF)
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.
From Baseline to Week 26 (LOCF)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de participantes que experimentan al menos un evento adverso emergente del tratamiento (TEAE) y eventos adversos graves (SAE)
Periodo de tiempo: Hasta la semana 26
Hasta la semana 26
Número de participantes con valores de signos vitales marcadamente anormales
Periodo de tiempo: Hasta la semana 26
Hasta la semana 26
Número de participantes con TEAE relacionados con pruebas de laboratorio clínico
Periodo de tiempo: Hasta la semana 26
Hasta la semana 26
Change From Baseline in MDS-UPDRS Part I Total Score
Periodo de tiempo: Baseline and Week 26 (LOCF)
For MDS-UPDRS Part I (non-motor experiences of daily living) scores, the scale range for Part I Total Score was 0-52, with higher scores reflecting greater severity.
Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part II Total Score
Periodo de tiempo: Baseline and Week 26 (LOCF)
For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part III Total Score
Periodo de tiempo: Baseline and Week 26 (LOCF)
For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.
Baseline and Week 26 (LOCF)
Number of Participants With TEAE Related to Body Weight
Periodo de tiempo: Up to Week 26
Up to Week 26
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Periodo de tiempo: Up to Week 26
Up to Week 26

Colaboradores e Investigadores

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

Patrocinador

Takeda

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

7 de febrero de 2015

Finalización primaria (Actual)

15 de septiembre de 2016

Finalización del estudio (Actual)

15 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

9 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2015

Publicado por primera vez (Estimar)

14 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de marzo de 2022

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

17 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TVP-1012/CCT-001
  • U1111-1165-1302 (Identificador de registro: WHO)
  • JapicCTI-152760 (Identificador de registro: JapicCTI)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Criterios de acceso compartido de IPD

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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