A Study to Examine APL-130277 in Patients With Parkinson's Disease

NCT ID: NCT02228590

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-24

Brief 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)

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APL-130277

open label baseline comparison

Group Type: OTHER

APL-130277

Intervention Type: DRUG

Apomorphine Hydrochloride, Sublingual Thin Film

Interventions

APL-130277

Apomorphine Hydrochloride, Sublingual Thin Film

Intervention Type: DRUG

Other Intervention Names

Apomorphine Hydrochloride, Sublingual Thin Film

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CNS Medical Director

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Banner Sun Health Research Institute

Sun City, Arizona, United States

Rocky Mountain Movement Disorders Center

Englewood, Colorado, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

University of South Florida Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTH-105

Identifier Type: -

Identifier Source: org_study_id