Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
Conditions
Interventions
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
Pharmaceutical Form: Tablet
INN or Proposed INN: TAVAPADON
CAS Number: 1643489-24-0
Current Sponsor code: Tavapadon (CVL-751)
Other descriptive nam
Sponsors
Cerevel Therapeutics, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.,Male and female subjects aged 40 to 80 years, inclusive, at the time of signing the ICF. 2.,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. 3.,Subjects who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 4.,Subjects 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. 5.,Subjects with a diagnosis of that is consistent with the UK Parkinson’s Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry 6.,Subjects with modified Hoehn and Yahr stage 1, 1.5, or 2. 7.,Subjects with disease duration (from time of diagnosis) of 90 days before signing of the ICF and the dosage will remain stable for the duration of the trial (ie, no change in the MAO B inhibitor dose is permitted during the trial). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.,Subjects 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). 2. Subjects with a history of nonresponse or insufficient response to L-Dopa or 2 or more other antiparkinsonian drugs at therapeutic dosages. 3.,Subjects who have had previous surgical intervention (eg, deep brain stimulation) for PD or for whom such a procedure is planned or anticipated during the trial period. 4.,Subjects with an acute or chronic, clinically significant medical or psychiatric condition, cognitive impairment, or laboratory abnormality that might increase the risk associated with trial participation or administration of trial treatment or interfere with the interpretation of the trial results or that, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. Medical conditions that are minor or well controlled may be considered acceptable if the condition does not expose the subject to an undue risk of a significant AE or interfere with the assessments of safety or efficacy during the course of the trial. Subjects with symptoms of anxiety or depression that are not debilitating and that are stable or adequately controlled with non-prohibited medication are considered acceptable. The medical monitor should be contacted in any instance where the investigator is uncertain regarding the stability of a subject’s medical conditions(s) and the potential impact of the condition(s) on trial participation. 5.,Subjects with a history or current diagnosis of a clinically significant impulse control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM 5) (American Psychiatric Association, 2013). 6.,Subjects 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 7.,Subjects with a history of psychosis or hallucinations within the previous 12 months based on medical records or subject/caregiver feedback 8.,Subjects 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 Subjects 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 Subjects who, in the opinion of the investigator, present a serious risk of suicide. 9.,Subjects with substance abuse or dependence disorder, including alcohol, benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180 days). 10.,Subjects with dementia or cognitive impairment that, in the judgement of the investigator, would exclude the subject from understanding the ICF or participating in the trial. 11. Subjects with a MoCA score <26. 12. Subjects who previously participated in any tavapadon trial, including this trial, and received IMP. 13. Subjects who received treatment with any other investigational drug within 60 days before signing the I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the efficacy of 2 fixed doses of tavapadon in subjects with early PD;Secondary Objective: To assess the safety and tolerability of 2 fixed doses of tavapadon in subjects with early PD;Primary end point(s): Primary Efficacy Endpoint •Change from baseline to endpoint in the MDS UPDRS Parts II and III combined score ;Timepoint(s) of evaluation of this end point: Key Secondary Efficacy Endpoints •Percentage of responders at endpoint, defined as a score of “much improved” or “very much improved” on the PGIC •Change from baseline to endpoint in the MDS UPDRS Part II score Secondary Efficacy Endpoints (All Time Points) •Change from baseline in the MDS-UPDRS Parts II and III combined score •Change from baseline in the MDS-UPDRS Parts I, II, and III combined score •Change from baseline in the MDS-UPDRS Part I, Part II, and Part III individual scores •Change from baseline in the CGI S score •CGI I score •PGIC score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To assess the safety and tolerability of 2 fixed doses of tavapadon in subjects with early PD | — |
Countries
Australia, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Serbia, Spain, Sweden, Ukraine, United States
Contacts
Public ContactStephanie Pfister
Cerevel Therapeutics, LLC
Outcome results
None listed