An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
DescriptionA 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and efficacy of APL-130277.
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Completion of the CTH-301 study, and in the opinion of the Investigator, would benefit from continued treatment with APL-130277.
- If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control: - Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants); - Intrauterine contraceptive system; - Surgical sterilization or partner sterile (must have documented proof); AND One of the following effective methods of birth control: - Male/female condom; - Cervical cap with spermicide; - Diaphragm with spermicide; - Contraceptive sponge.
- Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
- Able to understand the consent form, and to provide written informed consent.
- Female who is pregnant or lactating.
- Presence of any major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including clinically significant hallucinations during the past 6 months) or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
- Presence of any clinically significant medical (including CNS or CV events), surgical, or laboratory abnormality that would make study participation unsafe or make treatment compliance difficult. Clinical significance to be determined by the Investigator.
- Receipt of any investigational (ie, unapproved) medication or participation in any clinical trial since completing the CTH-301 study.
- Development of canker or mouth sores since completing the CTH-301 study. For other clinically significant oral pathology, the Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling such a patient into the study. Clinical significance to be determined by the Investigator.
- Current suicidal ideation as evidenced by answering "yes" to Question 4 or 5 on the suicidal ideation portion of the C-SSRS at the Screening Visit Phase 2 (SVP2).
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.