An Open-Label Phase 3 Study to Examine the Long-Term Safety Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    226
  • sponsor
    Sunovion
Updated on 2 April 2020
levodopa
mini-mental state examination
carbidopa
dopa
hoehn and yahr scale

Summary

An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

Description


Details
Condition Parkinson's disease, Parkinson's disease
Treatment APL-130277
Clinical Study IdentifierNCT02542696
SponsorSunovion
Last Modified on2 April 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Completion of the CTH-301 study under protocol version 3.00, 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. 3\. 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. 4\. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures. 5\. Able to understand the consent form, and to provide written informed consent

Exclusion Criteria

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 in unsafe or make treatment compliance difficult
Presence of any clinically significant medical (including but not limited to CNS, cardiovascular, hepatic, pulmonary, metabolic, or renal 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)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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