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Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson's disease
- Source :
- Movement Disorders. 31:1366-1372
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
Abstract
- Introduction OFF episodes negatively impact quality of life in patients with Parkinson's disease (PD). There remains a need for an acute, effective, noninvasive treatment. Background APL-130277 is a sublingually administered apomorphine oral strip. Methods The authors conducted a phase 2, open-label, proof-of-concept study. Patients presented to clinic in the morning in the practically defined OFF state and were dosed with APL-130277 10 mg. Assessments of OFF or ON state and MDS-UPDRS part III were conducted predose and at 15, 30, 45, 60, and 90 minutes. If a full ON was not achieved within 3 hours, the dose was increased in 5 mg increments until a full ON was achieved or to a maximum dose of 30 mg. Patients could be dosed up to two times a day over 3 days. Patients were pretreated with trimethobenzamide for 3 days, which was continued during the study. Results Of 19 patients, 15 (78.9%) achieved a full ON response. All 15 achieved a full ON response within 30 minutes and 6 of the 15 patients (40.0%) achieved a full ON response within 15 minutes. The mean (SD) duration of ON was 50 (19.4) minutes. Of the 15 patients, 9 (60.0%) remained fully ON for ≥90 minutes. There were no discontinuations as a result of an adverse event. The most common adverse events were dizziness (36.8%), somnolence (31.6%), and nausea (21.1%). Conclusion This was the first study of a new sublingual apomorphine formulation in PD patients. In this open-label study, APL-130277 appeared to provide a convenient, rapid, and reliable method for treating OFF episodes. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society
- Subjects :
- Parkinson's disease
Trimethobenzamide
Movement disorders
Nausea
business.industry
medicine.disease
Apomorphine
03 medical and health sciences
0302 clinical medicine
Neurology
030220 oncology & carcinogenesis
Anesthesia
medicine
Neurology (clinical)
medicine.symptom
Adverse effect
business
030217 neurology & neurosurgery
Somnolence
medicine.drug
Morning
Subjects
Details
- ISSN :
- 08853185
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- Movement Disorders
- Accession number :
- edsair.doi...........e7273c552e28b23beea07cfd32f197cd