scholarly journals Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study

2021 ◽  
Vol Volume 14 ◽  
pp. 809-819
Author(s):  
Soichiro Hozawa ◽  
Hiroyuki Ohbayashi ◽  
Michiko Tsuchiya ◽  
Yu Hara ◽  
Laurie A Lee ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Japanese Patients ◽  
Phase Iii ◽  
Fluticasone Furoate ◽  
Open Label ◽  
Once Daily ◽  
Open Label Study ◽  
Label Study

ADHD Treatment With Once-Daily OROS Methylphenidate: Final Results From a Long-Term Open-Label Study

2005 ◽  
Vol 44 (10) ◽  
pp. 1015-1023 ◽  
Author(s):  
Timothy Wilens ◽  
Keith MCBurnett ◽  
Mark Stein ◽  
Marc Lerner ◽  
Thomas Spencer ◽  
...  
Keyword(s):  
Open Label ◽  
Once Daily ◽  
Open Label Study ◽  
Label Study ◽  
Adhd Treatment

scholarly journals A long-term, open-label study of valbenazine for tardive dyskinesia

CNS Spectrums ◽  
2020 ◽  
pp. 1-9
Author(s):  
Jean-Pierre Lindenmayer ◽  
Cherian Verghese ◽  
Stephen R. Marder ◽  
Joshua Burke ◽  
Roland Jimenez ◽  
...  
Keyword(s):  
Tardive Dyskinesia ◽  
Open Label ◽  
Term Study ◽  
Once Daily ◽  
Open Label Study ◽  
Patient Satisfaction Questionnaire ◽  
Label Study ◽  
Satisfaction Questionnaire ◽  
Long Term Study

Abstract Background. Individuals with tardive dyskinesia (TD) who completed a long-term study (KINECT 3 or KINECT 4) of valbenazine (40 or 80 mg/day, once-daily for up to 48 weeks followed by 4-week washout) were enrolled in a subsequent study (NCT02736955) that was primarily designed to further evaluate the long-term safety of valbenazine. Methods. Participants were initiated at 40 mg/day (following prior valbenazine washout). At week 4, dosing was escalated to 80 mg/day based on tolerability and clinical assessment of TD; reduction to 40 mg/day was allowed for tolerability. The study was planned for 72 weeks or until termination due to commercial availability of valbenazine. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs). Results. At study termination, 85.7% (138/161) of participants were still active. Four participants had reached week 60, and none reached week 72. The percentage of participants with a CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from study baseline (14.5% [23/159]) to week 48 (64.3% [36/56]). At baseline, 98.8% (158/160) of participants rated their prior valbenazine experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At week 48, 98.2% (55/56) remained satisfied. Before week 4 (dose escalation), 9.4% of participants had ≥1 TEAE. After week 4, the TEAE incidence was 49.0%. No TEAE occurred in ≥5% of participants during treatment (before or after week 4). Conclusions. Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.

Multicenter, Open-Label Study of Long-Term Administration of Febuxostat (TMX-67) in Japanese Patients With Hyperuricemia Including Gout

2011 ◽  
Vol 17 (Suppl 2) ◽  
pp. S50-S56 ◽  
Author(s):  
Naoyuki Kamatani ◽  
Shin Fujimori ◽  
Toshikazu Hada ◽  
Tatsuo Hosoya ◽  
Kenjiro Kohri ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Term Administration
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