Abstract | OBJECTIVES: METHODS: This was a phase 3, multicenter, open-label, long-term study in PD patients experiencing wearing-off who had previously completed a double-blind placebo-controlled clinical study of istradefylline in Japan. Istradefylline was administered for 52 weeks at a starting dosage of 20 mg/d, with or without dosage adjustment up to 40 mg/d. Safety was assessed using the incidence of treatment-emergent adverse events, and efficacy was assessed as the change in the daily off time. RESULTS: A total of 308 patients were included in this study. The most frequently reported treatment-emergent adverse events were nasopharyngitis (24.4%) and dyskinesia (21.4%). The mean change in the daily off time from day 1 was -0.65 hour in week 2, fluctuating between -0.71 and -0.04 hour until week 52 in patients who had previously taken placebo in the preceding double-blind study. The off time reduction from baseline of the double-blind study remained at similar levels between weeks 2 and 52 in patients who had previously taken istradefylline 20 and 40 mg/d in the preceding double-blind study. CONCLUSIONS: This study showed that istradefylline treatment was well tolerated and produced a sustained reduction in off time in levodopa-treated PD patients over a 52-week period.
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Authors | Tomoyoshi Kondo, Yoshikuni Mizuno, Japanese Istradefylline Study Group |
Journal | Clinical neuropharmacology
(Clin Neuropharmacol)
2015 Mar-Apr
Vol. 38
Issue 2
Pg. 41-6
ISSN: 1537-162X [Electronic] United States |
PMID | 25768849
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adenosine A2 Receptor Antagonists
- Purines
- istradefylline
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Topics |
- Adenosine A2 Receptor Antagonists
(therapeutic use)
- Aged
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Longitudinal Studies
- Male
- Middle Aged
- Parkinson Disease
(drug therapy)
- Purines
(therapeutic use)
- Severity of Illness Index
- Time Factors
- Treatment Outcome
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