Fixed-Dose Trial in Early Parkinson's Disease (TemPo-1)

  • STATUS
    Recruiting
  • End date
    Oct 24, 2022
  • participants needed
    522
  • sponsor
    Cerevel Therapeutics, LLC
Updated on 12 September 2021
Investigator
Reference Study ID Number: BN42358 www.roche.com/about_roche/roche_worldwide.htm
Primary Contact
Raleigh Neurology Associates (3.7 mi away) Contact
+78 other location
dopamine
cognitive impairment
dopamine agonists
levodopa
dementia
hallucinations
parkinsonism
tremor
essential tremor
dopa
bradykinesia
impulse control disorder
antiparkinsonian agents
early parkinson's
mao-b inhibitor

Summary

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early Parkinson's Disease.

Description

An estimated total of 522 eligible subjects with early Parkinson's Disease, will be randomized to 3 treatment groups.  Subjects will be randomized in a 1:1:1 ratio to receive tavapadon 5 mg, tavapadon 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 IdentifierNCT04201093
SponsorCerevel Therapeutics, LLC
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female participants aged 40 to 80 years, inclusive, at the time of signing the ICF (Informed consent form)
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 less than (<) 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 <3 months and not within 2 months of signing the ICF. Prior and concurrent use of Monoamine oxidase (MAO)-B inhibitors is permitted if use was initiated > 90 days before signing of the ICF and the dosage will remain stable for the duration of the trial (i.e, no change in the 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
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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