Flexible-Dose Trial in Early Parkinson's Disease (TemPo-2)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2022
  • participants needed
    296
  • sponsor
    Cerevel Therapeutics, LLC
Updated on 31 July 2021
Investigator
Jennifer Coates
Primary Contact
Neurosciences Research (9.0 mi away) Contact
+48 other location
dopamine
dopamine agonists
levodopa
dopa
bradykinesia
early parkinson's

Summary

The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

Description

An estimated total of 296 eligible subjects with early Parkinson's Disease, will be randomized to 3 treatment groups.  will be randomized in a 1:1 ratio to receive tavapadon 5 to 15 mg or placebo.  Each subject will participate in the study for approximately 35 weeks including a 30 day screening period, 27 week treatment period, and 4 week follow-up period.

Subjects may continue to an optional open-label extension period for one year.

Details
Condition Parkinson's disease
Treatment Placebo, Tavapadon
Clinical Study IdentifierNCT04223193
SponsorCerevel Therapeutics, LLC
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sexually active men or women of childbearing potential must agree to practice effective birth control or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment
Participants with a diagnosis of that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry
Participants with modified Hoehn and Yahr stage 1, 1.5, or 2
Participants with disease duration (from time of diagnosis) of <3 years and disease progression in the 3 years before signing the Informed Consent Form (ICF)
Participants with an MDS-UPDRS Part II score greater than or equal to(>=) 2 and Part III score 10 at the Screening Visit
Participants with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management
Participants who are treatment nave or have a history of prior incidental treatment with dopaminergic agents (including L-Dopa and dopamine receptor agonist medications) for less than (<) 3 months and not within 2 months of signing the ICF. Prior and concurrent use of MAO-B inhibitors is permitted if use was initiated greater than (>) 90 days before signing of the ICF and the dosage will remain stable for the duration of the trial (no change in the Monoamine oxidase B (MAO-B) inhibitor dose is permitted during the trial)
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

Exclusion Criteria

Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or post stroke parkinsonism)
Participants with a history of nonresponse or insufficient response to L-Dopa or 2 or more other antiparkinsonian drugs at therapeutic dosages
Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5)
Participants with the presence of or history of brain tumor, hospitalization for severe head trauma, epilepsy (as defined by the International League Against Epilepsy), or seizures
Participants with a history of psychosis or hallucinations within the previous 12 months based on medical records or participant/caregiver feedback
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 with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days)
Participants with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the participant from understanding the ICF or participating in the trial
Participants with any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding)
Participants with a history of neuroleptic malignant syndrome
Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration)
Participants with a positive urine drug screen for illicit drugs are excluded and may not be retested or rescreened. Participants with a positive urine drug screen resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product), prescription, or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the participant or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor
Participants with a Montreal Cognitive Assessment (MoCA) score <26\
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