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A Study to Examine APL-130277 in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02228590
First Posted: August 29, 2014
Last Update Posted: February 3, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunovion
  Purpose
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)

Condition Intervention Phase
Parkinson's Disease Drug: APL-130277 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Evaluate the efficacy based on time to ON, percent change in UPDRS. Safety as assessed by adverse events, vital signs and ECGs [ Time Frame: between 0 and 90 minutes ]

Secondary Outcome Measures:
  • Evaluate the efficacy, safety and tolerability of treatment with APL-130277 in 16 patients with Parkinson's Disease (PD). [ Time Frame: Single Day ]

Enrollment: 19
Study Start Date: August 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
APL-130277
open label baseline comparison
Drug: APL-130277
Apomorphine Hydrochloride, Sublingual Thin Film
Other Name: Apomorphine Hydrochloride, Sublingual Thin Film

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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): NCT02228590


Locations
United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, Colorado
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of South Florida Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
Sponsors and Collaborators
Sunovion
Investigators
Study Director: CNS Medical Director Sunovion
  More Information

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02228590     History of Changes
Other Study ID Numbers: CTH-105
First Submitted: August 26, 2014
First Posted: August 29, 2014
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Sunovion:
Parkinson's Disease

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