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A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes | Clinical Trials | Clareo Health

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A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

A Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

NCT03292016•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

A study that compares the extent to which apomorphine becomes available in the body after taking either an investigational drug containing apomorphine or apomorphine that is injected under the skin in people with PD complicated by "OFF" episodes.

Detailed Description

This multi-center study will aim to evaluate the pharmacokinetics (PK) and comparative bioavailability of a single dose of APL-130277 sublingual thin film with subcutaneous (s.c.) APO-go® and s.c. APOKYN® in subjects with Parkinson's disease (PD). The dose of APOKYN® (≤ 5 mg) will be based on the subjects' current prescribed dose. The study is designed as an open-label, randomized, three-way crossover. Subjects will receive all three treatment arms with a minimum 1-day wash-out between each visit (excluding the screening visit) and will be randomly assigned to one of the six sequences

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥ 18 years of age.
•2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the "more than one affected relative" criterion).
•3. Clinically meaningful response to Levodopa (L-Dopa) with well-defined "OFF" episodes, as determined by the Investigator.
•4. Receiving APOKYN® of ≤ 5 mg per dose for at least 4 weeks before the Screening Visit.
•5. Receiving stable doses of L-Dopa/carbidopa (immediate or sustained release) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the Screening Visit. Adjunctive PD medication regimens must be maintained at a stable dose for at least 4 weeks prior to the Screening Visit with the exception that MAOB inhibitors must be maintained at a stable level for at least 8 weeks prior to the Screening Visit.
•6. No planned medication change(s) or surgical intervention anticipated during the course of study.
•7. Patients must experience a well-defined "OFF" episode in the morning if they do not take their morning PD medications on schedule, and must be willing to delay morning doses on the 3 study dosing days
•8. Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
•9. Mini-Mental State Examination (MMSE) score \> 23.
•10. If female and of childbearing potential, must agree to use one of the following methods of birth control:
+12 more criteria

Exclusion Criteria

•1. Atypical or secondary parkinsonism.
•2. Previous treatment with any of the following: continuous subcutaneous (s.c.) apomorphine infusion; or Duodopa/Duopa.
•3. Contraindications to APO-go® or APOKYN® or hypersensitivity to apomorphine hydrochloride or any marcrolide antibiotic or any of the ingredients APO-go® or APOKYN® (notably sodium metabisulfite).
•4. Female who is pregnant or lactating.
•5. Participation in a clinical trial within 30 days prior to the Screening Visit.
•6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the Screening Visit.
•7. Any selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine and clozapine) or dopamine depleting agents within 30 days prior to the Screening Visit.
•8. Drug or alcohol dependency in the past 12 months.
•9. History of malignant melanoma.
•10. Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
+7 more criteria

Locations (3)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Parkinson's Disese Treatment Center of SW Florida

Port Charlotte, Florida, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Key Dates

Start Date

August 22, 2017

Primary Completion Date

March 5, 2019

Completion Date

March 5, 2019

Last Updated

August 13, 2020

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

APL-130277

DRUG

APO-go

DRUG

Apokyn

DRUG

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Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients