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Dopamine Agonist

APL-130277 for Parkinson's Disease

Phase 3
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's effective and safe for treating "OFF" episodes in people with Parkinson's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase
Secondary outcome measures
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.
+15 more

Side effects data

From 2021 Phase 3 trial • 113 Patients • NCT03391882
31%
Nausea
10%
Dizziness
9%
Somnolence
8%
Dyskinesia
6%
Fatigue
4%
Orthostatic hypotension
3%
Yawning
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A Dose Titration: APL (APL-130277)
Part A Dose Titration: SC (Subcutaneous Apomorphine)
Part B Treatment: APL (APL-130277)
Part B Treatment: SC (Subcutaneous Apomorphine)

Trial Design

1Treatment groups
Experimental Treatment
Group I: APL-130277Experimental Treatment1 Intervention
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APL-130277
2015
Completed Phase 3
~830

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,224 Total Patients Enrolled
SunovionLead Sponsor
191 Previous Clinical Trials
50,219 Total Patients Enrolled
CNS Medical DirectorStudy DirectorSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,286 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2015. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02542696.
~52 spots leftby Apr 2025
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