SHS_543115 ROSU CCYN 16046

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)

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.

Newly diagnosed patients:
Select 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.

Select 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; Tigan; or domperidone.
Currently taking selective 5HT3 antagonists, dopamine antagonists (excluding quetiapine and clozapine), or dopamine depleting agents.
Drug or alcohol dependency in the past 12 months.
History of malignant melanoma.
Major psychiatric disorder.
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):
Select 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.

Select 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.
Phase III
NCT02542696
Neurosciences, All Other
Brain
Susie Ro, M.D.
Cynapsus
Carol Kemp
  • Swedish Medical Center