Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
1/11/2024

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
Not applicable
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
Active, not 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
Accrual to date
Final
992
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
Macquarie Park, 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
2109 - 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Vermont
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Pleven
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Czechia
State/province [25] 0 0
Chocen
Country [26] 0 0
Czechia
State/province [26] 0 0
Czech Republic
Country [27] 0 0
Czechia
State/province [27] 0 0
Prague
Country [28] 0 0
Czechia
State/province [28] 0 0
Rychnov Nad Knežnou
Country [29] 0 0
France
State/province [29] 0 0
Creteil
Country [30] 0 0
France
State/province [30] 0 0
Bron
Country [31] 0 0
France
State/province [31] 0 0
Grenoble
Country [32] 0 0
France
State/province [32] 0 0
Nancy
Country [33] 0 0
France
State/province [33] 0 0
Nîmes cedex 09
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg
Country [35] 0 0
France
State/province [35] 0 0
Toulouse
Country [36] 0 0
Germany
State/province [36] 0 0
Muenster
Country [37] 0 0
Germany
State/province [37] 0 0
Bad Homburg
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bochum
Country [40] 0 0
Germany
State/province [40] 0 0
Gera
Country [41] 0 0
Germany
State/province [41] 0 0
Haag In Oberbayern
Country [42] 0 0
Germany
State/province [42] 0 0
Muenchen
Country [43] 0 0
Germany
State/province [43] 0 0
Stadtroda
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Hungary
State/province [45] 0 0
Pécs
Country [46] 0 0
Hungary
State/province [46] 0 0
Tatabánya
Country [47] 0 0
Israel
State/province [47] 0 0
Haifa
Country [48] 0 0
Israel
State/province [48] 0 0
Petah Tiqva
Country [49] 0 0
Israel
State/province [49] 0 0
Ramat Gan
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Aviv
Country [51] 0 0
Italy
State/province [51] 0 0
Cassino
Country [52] 0 0
Italy
State/province [52] 0 0
Milano
Country [53] 0 0
Italy
State/province [53] 0 0
Padova
Country [54] 0 0
Italy
State/province [54] 0 0
Pisa
Country [55] 0 0
Italy
State/province [55] 0 0
Rome
Country [56] 0 0
Italy
State/province [56] 0 0
Torino
Country [57] 0 0
Poland
State/province [57] 0 0
Cracow
Country [58] 0 0
Poland
State/province [58] 0 0
Siemianowice Slaskie
Country [59] 0 0
Poland
State/province [59] 0 0
Bydgoszcz
Country [60] 0 0
Poland
State/province [60] 0 0
Katowice
Country [61] 0 0
Poland
State/province [61] 0 0
Krakow
Country [62] 0 0
Poland
State/province [62] 0 0
Kraków
Country [63] 0 0
Poland
State/province [63] 0 0
Lublin
Country [64] 0 0
Poland
State/province [64] 0 0
Warsaw
Country [65] 0 0
Serbia
State/province [65] 0 0
Belgrade
Country [66] 0 0
Spain
State/province [66] 0 0
Alicante
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
San Sebastian
Country [70] 0 0
Spain
State/province [70] 0 0
Terrassa
Country [71] 0 0
Spain
State/province [71] 0 0
Valencia
Country [72] 0 0
Ukraine
State/province [72] 0 0
Zaporiizhzhya
Country [73] 0 0
Ukraine
State/province [73] 0 0
Lviv
Country [74] 0 0
Ukraine
State/province [74] 0 0
Vinnitsa
Country [75] 0 0
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
The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.
Trial website
https://clinicaltrials.gov/study/NCT04760769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE Inc.
Address 0 0
AbbVie
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04760769