CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 133 enrolled
Drug / intervention
Midazolam +6 moredrug
Likely dose
Midazolam 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01462318
NCT01462318Phase 3Completed
CompareCT.gov

A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis

Biogen·interventional·Posted Oct 31, 2011·Updated Mar 14, 2017

In Brief

A Phase 3 clinical trial evaluating Midazolam, Caffeine, and 5 other interventions for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 133 participants across 19 sites in 4 countries.

Detailed Summary

The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesCzechia, Hungary, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2011
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.7 years ago

Interventions

Midazolamdrug

5 mg

Caffeineother

200 mg

S-warfarindrug

10 mg

Vitamin Kother

10 mg

Omeprazoledrug

40 mg

Dextromethorphandrug

30 mg

BIIB019 (Daclizumab)biological

150 mg in 1 ml PFS