Status:
COMPLETED
Minocycline in Clinically Isolated Syndromes (CIS)
Lead Sponsor:
Dr. Luanne Metz
Collaborating Sponsors:
Multiple Sclerosis Society of Canada
Conditions:
Clinically Isolated Syndromes
Early Single Relapse of Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 mon...
Detailed Description
* Minocycline 100 mg bid orally compared to identical placebo * Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event suggestive of multiple sclerosis (At baseline par...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years.
- First focal clinical episode suggestive of demyelinating disease within the previous 180 days (measured from onset of the first symptom to treatment start), based on the appearance of a neurological abnormality, present for at least 24 hours.
- Objective clinical evidence must be present or documented. Patients will be included irrespective of whether the first clinical demyelinating episode was monosymptomatic (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence of more than one lesion).
- At least two lesions on the T2-weighted brain MRI\* scan at least one of which is ovoid or periventricular or infratentorial. MRI eligibility will be determined centrally by the UBC MS/MRI Research Group.\*One lesion on spinal MRI may substitute for one brain lesion as per the 2005 McDonald Criteria.
- Sexually active women of child-bearing potential must agree to use adequate contraception.
- Written informed consent
Exclusion
- Any disease other than MS that could better explain the patient's signs and symptoms.
- Any previous clinical event reasonably attributable to acute demyelination, regardless of whether medical attention was obtained.
- Complete transverse myelitis or bilateral optic neuritis. A waiver can be obtained for bilateral optic neuritis but must be obtained prior to randomization. Waivers must be approved by 3 neurologists including a member of the Clinical Eligibility / Endpoint Committee, a member of the DSMC, and by an experienced MS neurophthalmologist.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00666887
Start Date
January 1 2009
End Date
July 1 2015
Last Update
February 27 2017
Active Locations (12)
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1
University of Calgary, Calgary Health Region
Calgary, Alberta, Canada, T2N 4N1
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
3
Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia, Canada, V5G 2X6
4
UBC Hospital
Vancouver, British Columbia, Canada, V6T 2B5