Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Tavapadon 5mg
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 name:
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 2, 2.5, or 3 in the “on” state. 7.Subjects with a good response to L-Dopa in the judgment of the investigator. 8.Subjects who return a completed self-reported home diary for motor function status (Hauser diary) during the screening period (after diary training and concordance testing has occurred), with recordings for 2 consecutive days (ie, 2 consecutive 24 hour periods) showing at least 2½ hours of “off” time on each of the 2 days. 9.Subjects who are on a stable dose of L Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 mg divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended release carbidopa/levodopa capsules. The carbidopa/levodopa dose and frequency must be maintained for the duration of the trial. 10.Prior and concurrent use of COMT inhibitors, MAO B inhibitors, amantadine, or anticholinergic drugs is permitted if use was initiated >90 days before signing of the informed consent, the dosage has remained stable for a minimum of 4 weeks before signing of the informed consent, and the dosage will remain stable for the duration of the trial (ie, no change in the COMT, MAO B inhibitor, or amantadine 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 258
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 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) 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. 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 any condition that could possibly affect drug absorption, including bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include gastric banding). 12.Subjects who have a positive result for HIV antibodies, HbsAg, or HCV antibodies at screening. 13.Subjects with a history of malignancy other than: • Non-metastatic basal or squamous cell carcinoma of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of tavapadon on the change from baseline in total daily hours of “on” time without troublesome dyskinesia in L Dopa treated subjects with PD who are experiencing motor fluctuations;Secondary Objective: To assess the effect of tavapadon on the change from baseline in total daily hours of “off” time in L Dopa treated subjects with PD who are experiencing motor fluctuations;Primary end point(s): Primary efficacy endpoint: Change from baseline to endpoint the total “on” time without troublesome dyskinesia based on the 2 day average of the self-completed home diary for motor functional status (Hauser diary);Timepoint(s) of evaluation of this end point: Baseline up to 27 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoints • Change from baseline to endpoint in total daily “off” time based on the 2 day average of the self completed home diary for motor function status (Hauser diary) • Change from baseline in the total “on” time without troublesome dyskinesia based on the 2 day average of the self-completed home diary for motor function status (Hauser diary) • Change from baseline in the total “off” time without troublesome dyskinesia based on the 2 day average of the self-completed home diary for motor function status (Hauser diary) • Change from baseline in the MDS-UPDRS Part I score • Change from baseline in the MDS-UPDRS Part II score • Change from baseline in the MDS-UPDRS Part III score;Timepoint(s) of evaluation of this end point: Baseline up to 27 weeks | — |
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