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.
EU CTIS ID: 2024-512123-37-00
What this study is testing
To evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Democratic People's Republic of
- United States
- Taiwan
- Israel
- Canada
- Ukraine
- Thailand
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Democratic People's Republic of; United States; Taiwan; Israel; Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.