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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 currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Sunovion
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT02469090
First received: June 9, 2015
Last updated: June 29, 2017
Last verified: June 2017
June 9, 2015
June 29, 2017
June 2015
November 30, 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02469090 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Parkinson Disease
  • Drug: APL-130277
    Use to treat up to 5 "OFF" episodes per day
    Other Name: Apomorphine Hydrochloride, Sublingual Thin Film
  • Drug: Placebo
    placebo
  • Experimental: APL-130277
    APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
    Intervention: Drug: APL-130277
  • Placebo Comparator: Placebo
    Matching placebo for APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
November 30, 2017
November 30, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: CNS Medical Director 1-866-503-6351
Canada,   United States
United Kingdom
 
NCT02469090
CTH-300
Yes
Not Provided
Not Provided
Sunovion
Sunovion
Not Provided
Study Director: CNS Medical Director Sunovion
Sunovion
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP