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

  • STATUS
    Recruiting
  • End date
    Dec 6, 2024
  • participants needed
    531
  • sponsor
    Cerevel Therapeutics, LLC
Updated on 31 July 2021
Investigator
Jodi Macko
Primary Contact
Metrolina Neurological Associates and Diagnostic Center (5.0 mi away) Contact
+3 other location
levodopa
carbidopa
amantadine
bradykinesia

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 .

Description


Details
Condition Parkinson's disease
Treatment Tavapadon
Clinical Study IdentifierNCT04760769
SponsorCerevel Therapeutics, LLC
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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
-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 for the duration of the trial
De novo participant are eligible for the study if they met the following
inclusion
criteria
Male and female participants aged 40 to 80 years, inclusive, at the time of signing the ICF
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 able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures
Participants with a diagnosis of PD 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, 2, 2.5, or 3
Participants must be receiving some form of levodopa/carbidopa at the Screening Visit and must continue to use levodopa/carbidopa for the duration of the trial
Prior and concurrent use catechol-O-methyl transferase (COMT) Inhibitor, Monoamine Oxidase B (MAO-B) Inhibitors, amantadine, or anticholinergic drugs are permitted
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

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
De novo participants are excluded from the trial if any of the following
criteria met
Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism)
Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages
Participants with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [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 Columbia-Suicide Severity Rating Scale (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 judgment 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 Cytochrome P450 3A4 (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 less than (<) 26
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