A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL)

• Register: EUCTR
• Last refreshed on: 21 October 2024
• Main ID: EUCTR2019-002949-38-IT
• Date of registration: 21/01/2021
• Prospective Registration: No
• Primary sponsor: Cerevel Therapeutics LLC
• Public title: A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL)
• Scientific title: A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 TRIAL
• Date of first enrolment: 21/05/2020
• Target sample size: 522
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002949-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Serbia, Spain, Sweden, Ukraine, United States

Contacts

• Name: Stephanie Pfister
• Affiliation: Cerevel Therapeutics, LLC

• Name: Stephanie Pfister
• Affiliation: Cerevel Therapeutics, LLC

Key inclusion & exclusion 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 <3 years and disease progression in the 3 years before signing the ICF.
8.,Subjects with an MDS UPDRS Part II score =2 and Part III score =10 at the Screening Visit.
9.,Subjects with early PD who, in the opinion of the investigator, require pharmacologic intervention for disease management.
10.,Subjects who are treatment naïve 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 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 (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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 322

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 LDopa 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

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)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

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)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Tavapadon 1mg
Product Code: [CVL-751]
Pharmaceutical Form: Tablet
INN or Proposed INN: TAVAPADON
CAS Number: 1643489-24-0
Current Sponsor code: Tavapadon (CVL-751)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Change from baseline to endpoint in the MDS UPDRS Parts II and III combined score

Main Objective: To assess the efficacy of 2 fixed doses of tavapadon in subjects with early PD

Timepoint(s) of evaluation of this end point: Baseline up through week 27

Secondary Objective: To assess the safety and tolerability of 2 fixed doses of tavapadon in subjects with early PD

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline up through week 27

Secondary end point(s): • 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 ID(s)

2019-002949-38-HU

CVL-751-PD-001

Source(s) of Monetary Support

Cerevel Therapeutics, LLC

Ethics review

Status: Approved
Approval date: 20/05/2020
Contact: