Trial intelligence / Profile preview

Minocycline in Clinically Isolated Syndromes (MinoCIS)

NCT00666887Phase 3

Key facts

Status
Completed
Start
Jan 2009
Primary completion
Dec 2014
Countries
1
Modality
Small Molecules
Conditions
clinically isolated syndrome (CIS)multiple sclerosis (MS)
01

Overview

Phase 3, randomised, double-blind trial in clinically isolated syndrome (CIS) and multiple sclerosis (MS) comparing Minocycline Arm with Placebo Arm (2 arms). Primary endpoint: Conversion of CIS to McDonald Criteria MS at 6 months. Started Jan 2009; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Minocycline Arm

    Minocycline 100 mg twice daily for up to 24 months

  • Placebo Arm

    Placebo twice daily for up to 24 months

03

Who it enrols

Patients aged 18-60 with a first focal clinical episode suggestive of demyelinating disease within 180 days and specific MRI lesion criteria (at least two T2 lesions, one of which is ovoid, periventricular, or infratentorial).

04

Endpoints

Primary

  • Conversion of CIS to McDonald Criteria MS

Secondary

  • Conversion of CIS to McDonald Criteria MS at 2 years

  • Change in T2 lesion volume

  • Cumulative number of enhancing T1 lesions

  • Cumulative combined unique lesions

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