A Study to Examine the Long-Term Safety, Tolerability and Effectiveness of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients with Parkinson's Disease

Overview

About this study

A  study in L-Dopa responsive parkinson's disease patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and effectiveness of APL-130277.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

 

Inclusion Criteria

  • New Study Patients
    • 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
    • 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
  • Patients Rolling Over from CTH-300
    • 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

  • New Study Patients
    • Atypical or secondary parkinsonism
    • Previous treatment with any of the following
      • a neurosurgical procedure for PD
      • continuous subcutaneous (s.c.) apomorphine infusion
      • 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,US sites only)
      • Domperidone (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
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shyamal Mehta, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

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