A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease

Phase 1

Conditions: Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2019-002952-17-CZ

Lead Sponsor: Cerevel Therapeutics, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 854

Inclusion Criteria

Rollover Subjects:
- Subjects who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 or Trial CVL-751-PD-003 or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover subjects from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
- 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.
- 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.
- 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.
- Subjects who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.
- Subjects 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.

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 256
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 598

Exclusion Criteria

Rollover Subjects:
- Subjects who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial.
- Subjects who, in the judgement of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the subject may not be appropriate for a 58-week trial of tavapadon.
- Subjects who, in the judgment of the investigator, were noncompliant with trial procedures or with IMP administration during the double-blind trial.
- 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.
- Subjects who, in the judgment of the investigator, had a clinically significant medical, surgical, psychiatric, or laboratory abnormality after completing the last trial visit in the double-blind trial that would compromise participation in this trial.’
- Subjects who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD.;Secondary Objective: To evaluate the effects of tavapadon on PD symptoms during long-term treatment.<br><br>To evaluate the effects of tavapadon on L-Dopa usage <br><br>To evaluate speech and facial expression characteristics of subjects with PD (US sites only);Primary end point(s): To Evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD<br>•Nature, frequency, and temporality of TEAEs (nonserious and serious),<br>including abuse related AEs and AEs related to MHIs<br>•Frequency of discontinuations<br>•QUIP RS<br>•ESS<br>•C-SSRS<br>•SMWQ<br>•Clinical laboratory evaluations<br>•Vital signs<br>•Physical and neurological examinations<br>•ECGs<br><br>;Timepoint(s) of evaluation of this end point: Change from baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To Evaluate the effects of tavapadon on PD symptoms during long-term treatment<br>• Change from baseline in the MDS-UPDRS Parts I, II, and III scores<br>• Change from baseline in the Hauser diary (only in subjects who require daily L-Dopa or equivalent therapy for symptom control at the time of enrollment)<br>• Change from baseline in the EQ-5D-5L index and VAS scores<br><br>To evaluate the effects of tavapadon on L-Dopa usage <br>•Change from baseline in L-Dopa usage <br><br>To Evaluate speech and facial expression characteristics of subjects with PD<br>•Exploratory analyses of audio and video data collected from subject administered remote digital<br>testing of speech and facial expressions through an<br>interactive application platform on the subject's<br>personal mobile device may be conducted;Timepoint(s) of evaluation of this end point: Change from baseline<br><br><br>

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