20 results
The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
Primary: to compare the efficacy and safety of once daily (evening) administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >= 12 years of age with moderate to severe, persistent bronchial asthma over 12 weeks.Secondary:…
Efficacy and safety during 24 treatment weeks.
Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
Analyze the protective effect of intranasal corticosteroids against exercise induced upper and lower airway obstruction
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in patients with PPMS, including patients later in their disease course.
This study will evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis (RRMS) who have a suboptimal response to an adequate course of a disease modifying treatment (DMT).
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity (clinically and radiologically) compared to the standard (fixed 24 week interval) treatment.
This study will evaluate the efficacy and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis (RRMS).The objective of the Immune Substudy is to explore immunological changes associated with ocrelizumab treatment…
Primary:To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by thetime to onset of confirmed disability progression over the treatment period, defined as an increase…
This Extension study will evaluate the effectiveness and safety of ocrelizumab in MS patients who were previously enrolled in a Roche sponsored ocrelizumab phase IIIb/IV parent trial.
The objective of this prospective, randomized study is to investigate the efficacy and safety of HSCT compared to the comparator group (alemtuzumab, cladribine or ocrelizumab) in patients with aggressive relapsing remitting MS. In Norway, the…
We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
This study will evaluate the efficacy, safety, and pharmacokinetics of a higher dose of ocrelizumab compared with the approved dose of ocrelizumab in patients with relapsing forms of multiple sclerosis.
Main objective:English To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored\ Phase III pivotal studiesSecondary objectives:English To evaluate the longer-term efficacy of…
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.
This study will evaluate the effectiveness and safety of ocrelizumab in PMS patients.