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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04760769




Registration number
NCT04760769
Ethics application status
Date submitted
12/02/2021
Date registered
18/02/2021

Titles & IDs
Public title
Open-label Trial in Parkinson's Disease (PD)
Scientific title
58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Secondary ID [1] 0 0
2019-002952-17
Secondary ID [2] 0 0
CVL-751-PD-004
Universal Trial Number (UTN)
Trial acronym
TEMPO-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tavapadon

Experimental: Tavapadon - Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.


Treatment: Drugs: Tavapadon
Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
62 Weeks
Primary outcome [2] 0 0
Number of Participants Who Discontinued Study Treatment
Timepoint [2] 0 0
62 Weeks
Primary outcome [3] 0 0
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
Timepoint [3] 0 0
58 Weeks
Primary outcome [4] 0 0
Epworth Sleepiness Scale (ESS)
Timepoint [4] 0 0
58 Weeks
Primary outcome [5] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [5] 0 0
60 Weeks
Primary outcome [6] 0 0
Study Medication Withdrawal Questionnaire (SMWQ)
Timepoint [6] 0 0
60 Weeks
Primary outcome [7] 0 0
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
Timepoint [7] 0 0
60 Weeks
Primary outcome [8] 0 0
Change From Baseline in the Hauser diary
Timepoint [8] 0 0
58 Weeks
Primary outcome [9] 0 0
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
Timepoint [9] 0 0
Baseline (Day 1), Weeks 32 and 58
Primary outcome [10] 0 0
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
Timepoint [10] 0 0
Baseline (Day 1), Weeks 32 and 58

Eligibility
Key inclusion criteria
Key

Rollover participants are eligible for the study if they met the following inclusion criteria:

* Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
* Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
* Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
* Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
* Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.

Key
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Rollover participants are excluded from the trial if any of the following met:

* Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial
* Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
* Participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Erina, New South Wales - Erina
Recruitment hospital [2] 0 0
Kogarah - Kogarah
Recruitment hospital [3] 0 0
Sydney, New South Wales - Sydney
Recruitment hospital [4] 0 0
Woolloongabba, Queensland - Woolloongabba
Recruitment hospital [5] 0 0
Clayton, Victoria - Clayton
Recruitment hospital [6] 0 0
Parkville, Victoria - Parkville
Recruitment postcode(s) [1] 0 0
2250 - Erina
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Illinois
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Kansas
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Maine
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Massachusetts
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Michigan
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Vermont
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Washington
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Bulgaria
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Pleven
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Sofia
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Canada
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Ontario
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Czechia
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Chocen
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Czech Republic
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Prague
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Rychnov Nad Knežnou
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Pécs
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Haifa
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Ramat Gan
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Cassino
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Padova
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Pisa
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Rome
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Italy
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Torino
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Cracow
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Siemianowice Slaskie
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Bydgoszcz
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Katowice
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Krakow
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Kraków
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Lublin
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Warsaw
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Serbia
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Belgrade
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Alicante
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San Sebastian
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Terrassa
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Spain
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Valencia
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Ukraine
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Zaporiizhzhya
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Ukraine
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Lviv
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Ukraine
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Vinnitsa
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Ukraine
State/province [75] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cerevel Therapeutics, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cari Combs, MD
Address 0 0
Cerevel Therapeutics, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04760769