MedTrace Logo

Minocycline in Clinically Isolated Syndromes (CIS)

NCT00666887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2017-02-27

No results posted yet for this study

Summary

The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome).

A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.

Conditions

  • Clinically Isolated Syndromes
  • Early Single Relapse of Multiple Sclerosis

Interventions

DRUG

Minocycline

100 mg twice daily to be taken for up to 2 years

DRUG

Placebo

placebo twice daily for 2 years

Sponsors & Collaborators

  • Multiple Sclerosis Society of Canada

    collaborator OTHER

  • Dr. Luanne Metz

    lead OTHER

Principal Investigators

  • Luanne Metz, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-12-31
Completion
2015-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00666887 on ClinicalTrials.gov