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An 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

This study is currently recruiting participants.
Verified June 2017 by Sunovion
Sponsor:
ClinicalTrials.gov Identifier:
NCT02542696
First Posted: September 7, 2015
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  Purpose
A 24-week, prospective, multi-center, open-label, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and efficacy of APL-130277.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy 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:
  • Evaluation of safety and tolerability data collected, including 12-lead ECGs, orthostatic hypotension, oropharyngeal and dopaminergic AEs, and other pertinent safety parameters. [ Time Frame: Throughout the entire study ]

Estimated Enrollment: 226
Study Start Date: August 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (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
Used to treat up to 5 "OFF" episodes per day
Other Name: Apomorphine Hydrochloride, Sublingual Thin Film

  Eligibility

Information from the National Library of Medicine

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

De Novo Patients:

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 as determined by the Investigator.
  • Receiving stable doses of L-Dopa/carbidopa (immediate or chronic release) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1). 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

  • Atypical or secondary parkinsonism.
  • Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (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 and 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.

Patients Rolling Over from CTH-300 (Rollover Patients):

Inclusion Criteria

  • Completion of the CTH-300 study and, in the opinion of the Investigator, would benefit from continued treatment with APL-130277.
  • No treatment with any form of apomorphine (including APL-130277) for ≥ 2 weeks following completion of participation in CTH-300.
  • No concomitant medication changes (excluding apomorphine) since completion of participation in CTH-300 or planned medication change(s) or surgical intervention anticipated during the course of study.
  • MMSE score > 25.

Exclusion Criteria

  • Receipt of any investigational (i.e., unapproved) medication or participation in any clinical trial since participating in CTH-300.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542696


Contacts
Contact: CNS Medical Director 1-866-503-6351

  Show 62 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: CNS Medical Director Sunovion
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02542696     History of Changes
Other Study ID Numbers: CTH-301
2016-000637-43 ( EudraCT Number )
First Submitted: September 3, 2015
First Posted: September 7, 2015
Last Update Posted: June 9, 2017
Last Verified: June 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