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Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT02469090
First received: June 9, 2015
Last updated: August 3, 2017
Last verified: August 2017
  Purpose
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.

Condition Intervention Phase
Parkinson Disease Drug: APL-130277 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Mean change from pre-dose in MDS-UPDRS Part III Motor Examination (MDS-UPDRS MOTOR) at 30 minutes after dosing at the 12 week visit of the Maintenance Treatment Phase [ Time Frame: 30 minutes post-dose ]

Secondary Outcome Measures:
  • Percentage of patients with a patient-rated full "ON" response within 30 minutes at the 12 week visit of the Maintenance Treatment Phase [ Time Frame: 30 minutes post-dose ]

Enrollment: 126
Study Start Date: June 2015
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APL-130277
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
Drug: APL-130277
Use to treat up to 5 "OFF" episodes per day
Other Name: Apomorphine Hydrochloride, Sublingual Thin Film
Placebo Comparator: Placebo
Matching placebo for APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years of age.
  • Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.
  • Clinically meaningful response to L-Dopa with well-defined early morning "OFF" episodes, as determined by the Investigator.
  • Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit
  • No planned medication change(s) or surgical intervention anticipated during the course of study.
  • Patients must experience at least one well defined "OFF" episode per day with a total daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient self-assessment.
  • Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
  • MMSE score > 25.

Exclusion Criteria:

A patient will not be eligible for study entry if any of the following exclusion criteria are met:

  • Atypical or secondary parkinsonism.
  • Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; or Duodopa/Duopa.
  • Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
  • Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from US sites only); or domperidone (patients from non-US sites only).
  • Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
  • Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
  • Drug or alcohol dependency in the past 12 months.
  • History of malignant melanoma.
  • Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
  • Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
  • History of clinically significant hallucinations during the past 6 months.
  • History of clinically significant impulse control disorder(s).
  • Dementia that precludes providing informed consent or would interfere with participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02469090

  Show 33 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: CNS Medical Director Sunovion
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02469090     History of Changes
Other Study ID Numbers: CTH-300
Study First Received: June 9, 2015
Last Updated: August 3, 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Apomorphine
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017