Articles with "label extension" as a keyword



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Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial

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Published in 2020 at "The Lancet Neurology"

DOI: 10.1016/s1474-4422(20)30342-2

Abstract: BACKGROUND The safety and efficacy of ocrelizumab in primary progressive multiple sclerosis were shown in the phase 3 ORATORIO trial. In this study, we assessed the effects of maintaining or switching to ocrelizumab therapy on… read more here.

Keywords: open label; trial; oratorio; label extension ... See more keywords
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Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study

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Published in 2022 at "Current Medical Research and Opinion"

DOI: 10.1080/03007995.2022.2059975

Abstract: Abstract Background Galcanezumab, a monoclonal antibody to calcitonin gene-related peptide, was found to be safe and efficacious for the preventive treatment of chronic migraine based on the randomized, placebo-controlled double-blind period of the REGAIN study.… read more here.

Keywords: label extension; month; double blind; chronic migraine ... See more keywords

Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

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Published in 2022 at "AIDS"

DOI: 10.1097/qad.0000000000003175

Abstract: Objectives: People with HIV (PWH) are at an increased risk of atherosclerotic cardiovascular disease. Suboptimal responses to statin therapy in PWH may result from antiretroviral therapies (ARTs). This open-label extension study aimed to evaluate the… read more here.

Keywords: long term; label extension; open label; period ... See more keywords
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Fenfluramine HCl (Fintepla®) provides long‐term clinically meaningful reduction in seizure frequency: Analysis of an ongoing open‐label extension study

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Published in 2020 at "Epilepsia"

DOI: 10.1111/epi.16722

Abstract: Fenfluramine has been shown to provide clinically meaningful and statistically significant reductions in convulsive seizure frequency in children and adolescents (aged 2‐18 years) with Dravet syndrome in two randomized, placebo‐controlled clinical trials. The objective of… read more here.

Keywords: seizure frequency; clinically meaningful; label extension; open label ... See more keywords
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Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial

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Published in 2023 at "Cephalalgia"

DOI: 10.1177/03331024231161745

Abstract: Background Following the CENTURION phase 3 randomized controlled trial’s four-month double-blind phase, this 12-month open-label extension collected data for up to one year about dose optimization, patterns of use, migraine-related disability, and quality of life… read more here.

Keywords: extension; label extension; trial; lasmiditan patients ... See more keywords