scholarly journals Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study

2016 ◽  
Vol 234 (2) ◽  
pp. 199-209 ◽  
Author(s):  
Suresh Durgam ◽  
William M. Greenberg ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
Istvan Laszlovszky ◽  
...  
Keyword(s):  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Long Term Treatment ◽  
Open Label Extension

scholarly journals Long-term treatment of Cushing’s disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial

Endocrine ◽  
2017 ◽  
Vol 57 (1) ◽  
pp. 156-165 ◽  
Author(s):  
S. Petersenn ◽  
L. R. Salgado ◽  
J. Schopohl ◽  
L. Portocarrero-Ortiz ◽  
G. Arnaldi ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Term Treatment ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Extension Study ◽  
Open Label ◽  
Phase Iii Trial ◽  
Long Term Treatment ◽  
Open Label Extension

Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study

2019 ◽  
Vol 7 (8) ◽  
pp. 657-664 ◽  
Author(s):  
Ganesh Raghu ◽  
Bernt van den Blink ◽  
Mark J Hamblin ◽  
A Whitney Brown ◽  
Jeffrey A Golden ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Long Term Treatment ◽  
Open Label Extension

scholarly journals 172 A Phase 3, Multicenter Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Olanzapine/Samidorphan in Patients with Schizophrenia

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 309-310
Author(s):  
Sergey Yagoda ◽  
Christine Graham ◽  
Adam Simmons ◽  
Christina Arevalo ◽  
Yansong Cheng ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Study Drug ◽  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Phase 3 ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
Clinically Significant

Abstract:Background: ALKS 3831, a combination of olanzapine and samidorphan (OLZ/SAM), is in development for the treatment of schizophrenia and is intended to provide the antipsychotic efficacy of olanzapine while mitigating olanzapine-associated weight gain. We report the safety, tolerability, and efficacy of OLZ/SAM in patients with schizophrenia in a phase 3, 52-week, open-label extension study.Methods:Patients aged 18–70 years who completed a previous phase 3, 4-week, inpatient acute efficacy study were switched from OLZ/SAM, olanzapine, or placebo to OLZ/SAM. Study assessments included adverse events (AEs), weight, clinical laboratory testing, and Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores.Results:281 patients were enrolled; 277 (mean age, 41.4 years) received ≥1 dose of study drug, and 183 (66.1%) completed the extension study. The most common reasons for discontinuation were withdrawal by patient (15.5%), loss to follow-up (6.9%), and AEs (5.8%). AEs were reported in 136 (49.1%) patients; most were mild in severity. The most common AEs were increased weight (13.4%), somnolence (8.3%), nasopharyngitis (4.0%), and headache (4.0%). Mean weight increase from baseline in patients completing 52 weeks of treatment was 1.86 kg, a 2.79% increase. No clinically significant changes in mean laboratory parameters were observed. Mean (SD) changes from baseline to week 52 in PANSS total score and CGI-S score were –16.2 (15.41) and –0.9 (0.92), respectively (both P<0.001).Discussion:OLZ/SAM was generally well tolerated with a safety profile that supports long-term treatment. During this 52-week extension study, there were improvements in schizophrenia symptoms.Funding Acknowledgements:This study was funded by Alkermes, Inc.

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