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An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinsons Disease Complicated by Motor Fluctuations (OFF Episodes)

Description

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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