CVL-751 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病21

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002952-17-BG
(EUCTR)
31/05/202121/05/2021A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
2EUCTR2019-002952-17-DE
(EUCTR)
30/03/202118/09/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Czech Republic
3EUCTR2019-002952-17-IT
(EUCTR)
19/02/202125/01/2021A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5 mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Other descriptive name: TAVAPADON
Product Name: Tavapadon 1mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Other descriptive name: TAVAPADON
Product Name: Tavapadon 0.25 mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Other descriptive name: TAVAPADON
Cerevel Therapeutics LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
4EUCTR2019-002949-38-BG
(EUCTR)
13/01/202121/12/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
5EUCTR2019-002951-40-BG
(EUCTR)
11/01/202105/01/2021A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
6EUCTR2019-002952-17-HU
(EUCTR)
30/12/202019/10/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany
7EUCTR2019-002952-17-CZ
(EUCTR)
04/11/202012/10/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
8EUCTR2019-002951-40-IT
(EUCTR)
30/10/202021/01/2021A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: [CVL-751]
INN or Proposed INN: Tavapadon
Product Name: Tavapadon 1mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Product Name: Tavapadon 0.25mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Cerevel Therapeutics LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
9EUCTR2019-002949-38-DE
(EUCTR)
07/09/202021/01/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
552Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
10EUCTR2019-002951-40-DE
(EUCTR)
29/07/202012/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
11EUCTR2019-002951-40-HU
(EUCTR)
02/07/202029/04/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden
12EUCTR2019-002951-40-CZ
(EUCTR)
03/06/202025/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
13EUCTR2019-002950-22-IT
(EUCTR)
21/05/202015/06/2021A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's DiseaseA Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO 2 Trial) - TEMPO-2 Trial Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: [CVL-751]
INN or Proposed INN: Tavapadon
Other descriptive name: TAVAPADON
Product Name: Tavapadon 1mg
Product Code: [CVL-751]
INN or Proposed INN: Tavapadon
Other descriptive name: TAVAPADON
Product Name: Tavapadon 0.25mg
Product Code: [CVL-751]
INN or Proposed INN: Tavapadon
Other descriptive name: TAVAPADON
Cerevel Therapeutics LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
296Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Canada;Poland;Australia;Bulgaria;Germany
14EUCTR2019-002949-38-IT
(EUCTR)
21/05/202021/01/2021A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 TRIAL Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Product Name: Tavapadon 0.25mg
Product Code: [CVL-751]
INN or Proposed INN: Tavapadon
Product Name: Tavapadon 1mg
Product Code: [CVL-751]
INN or Proposed INN: TAVAPADON
Cerevel Therapeutics LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
15EUCTR2019-002949-38-PL
(EUCTR)
13/05/202020/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
16EUCTR2019-002950-22-HU
(EUCTR)
06/05/202012/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's DiseaseA Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
296Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany
17EUCTR2019-002951-40-ES
(EUCTR)
14/04/202006/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
18EUCTR2019-002949-38-ES
(EUCTR)
07/04/202028/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
19EUCTR2019-002949-38-CZ
(EUCTR)
04/03/202019/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 Trial Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany
20EUCTR2019-002949-38-HU
(EUCTR)
06/02/202017/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's DiseaseProduct Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Hungary;United States;Ukraine;Spain;Canada;Czech Republic;Sweden;Poland;Italy;Israel;Australia;Bulgaria;France;Serbia;Germany
21NCT04295642
(ClinicalTrials.gov)
January 8, 202024/1/2020A 2-Part Trial of CVL-751 in Subjects With Parkinson's DiseaseA 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: CVL-751Cerevel Therapeutics, LLCNULLCompleted45 Years75 YearsAll24Phase 1United States