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.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1003

Inclusion Criteria

1. 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 doubleblind 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., 2. 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., 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 who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial., 6. 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.

Exclusion Criteria

Rollover Subjects: 1. Subjects who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial., 2. 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., 3. Subjects who, in the judgment of the investigator, were noncompliant with trial procedures or with IMP administration during the double-blind trial., 4. 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 CSSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide., 5. 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.', 6. 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

Secondary Outcome Measures

Name	Time	Method

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