Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
|Start date||June 2015|
|End date||March 2017|
|Trial size||126 participants|
|Trial identifier||NCT02469090, CTH-300|
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.
Recruiting in the following locations…
|United States||Alabama, Arizona, California, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Maryland, and 8 other states|
|Overall Contact||CNS Medical Director|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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
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
Male or female participants at least 18 years old.
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.
|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)|
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