Clinical trial NCT02228590: A Study to Examine APL-130277 in Patients With Parkinson's Disease
Official title: A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277
timeFrame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.
measure: Time to 'ON' State From Time of Dosing of APL-130277
timeFrame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.
measure: Duration of 'ON' Response From Time of Dosing of APL-130277
timeFrame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.
measure: Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode
timeFrame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.
measure: Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.
measure: PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.
measure: PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast)
timeFrame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.
measure: PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90)
timeFrame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.
measure: PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast)
timeFrame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.
Secondary outcomes:
measure: Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment
timeFrame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Tampa
country: United States
facility: University of South Florida Parkinson's Disease and Movement Disorders Center
state: Florida
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: CNS Medical Director
role: STUDY_DIRECTOR
References: