The trial is taking place at:

TLC Research | Los Angeles, California

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Open-label Trial in Parkinson's Disease (PD) (TEMPO-4)

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Cerevel Therapeutics

Status and phase

Phase 3


Parkinson Disease


Drug: Tavapadon

Study type


Funder types



2019-002952-17 (EudraCT Number)

Details and patient eligibility


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.


1,200 estimated patients




40 to 80 years old


No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria: 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 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.

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

1,200 participants in 1 patient group

Experimental group
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.
Drug: Tavapadon

Trial contacts and locations



Data sourced from

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