A Study to Examine APL-130277 in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: APL-130277
Intervention description: Apomorphine Hydrochloride, Sublingual Thin Film
Intervention MeSH terms: Apomorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's Disease

Summary:

      The primary objective of this study is to evaluate the efficacy, tolerability and safety of
      single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age.

          2. Clinical diagnosis of Idiopathic PD

          3. Receiving stable doses of L-dopa +/- other adjunctive PD therapy for at least 4 weeks
             before study participation.

          4. At least one OFF episode per day and a total daily OFF time of > 2 hours duration.

          5. Experience predictable OFF episodes in the morning on awakening prior to receiving
             morning dose of levodopa.

          6. Stage I to III on the Hoehn and Yahr scale in the "ON" state.

          7. If female and of childbearing potential, must agree to use one of the following
             methods of birth control:

          8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
             and other study-related procedures to complete the study.

          9. Able to understand the consent form, and to provide written informed consent.

        Exclusion Criteria:

          1. Atypical or secondary parkinsonism

          2. Changes in L-dopa or other PD drug dosing regimens 4 weeks before the screening visit.

          3. Past treatment with any form of apomorphine within 30 days of Dosing Day 1 (patients
             who stopped apomorphine for reasons other than lack of efficacy OR tolerability issues
             may be considered for the trial).

          4. Female who is pregnant or lactating.

          5. Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of
             the ingredients of APOKYN (notably sodium metabisulfite), or Tigan®.

          6. Participation in any other clinical trial within 14 days of the screening visit.

          7. Receipt of any investigational (i.e., unapproved) medication within 30 days of the
             screening visit.

          8. Currently taking, or likely to need to take at any time during the course of the study

          9. Currently taking dopamine antagonists or depleting drugs excluding anticholinergics
             and/or antihistamines with anticholinergic effects.

         10. Drug or alcohol dependency in the past 6 months.

         11. Clinically significant orthostatic hypotension.

         12. Malignant melanoma or a history of previously treated malignant melanoma within 5
             years.

         13. Clinically significant medical surgical or laboratory abnormality in the judgment of
             the investigator.

         14. Psychiatric disorder, including but not limited to dementia or any disorder that, in
             the opinion of the Investigator requires ongoing treatment that would make study
             participation unsafe or make treatment compliance difficult.

         15. Dementia that precludes providing informed consent.

         16. Potential for lack of compliance and follow-up in the judgment of the investigator.

         17. Any other condition, current therapy, or prior therapy (within 30 days of the
             screening visit), which, in the opinion of the Investigator, would make the subject
             unsuitable for the study.

         18. Previous neurosurgery for PD.

         19. Donation of blood or plasma in the 30 days prior to dosing.

         20. Presence of cankers or mouth sores.