Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
142 participants
INTERVENTIONAL
2009-01-31
2015-07-31
Brief Summary
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A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.
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Detailed Description
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* Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event suggestive of multiple sclerosis (At baseline participants may meet 2010 McDonald diagnostic criteria for MS, but not 2005 criteria)
* Men and women, aged 18-60y, first event within the previous 180 days; brain magnetic resonance imaging (MRI) with at least two brain T2 lesions which are at least 3 mm in diameter, and at least one of which is ovoid or periventricular or infratentorial.
* Up to 24 months of study drug (Up to 12 months of study drug for patients recruited after December 31, 2012)
* Patients will be discontinued from the study when they convert to McDMS based on the 2005 McDonald definition.
* 12 Canadian MS Clinics
* A total of 154 patients will be randomized. Because 30% of screened patients with CIS who are clinically eligible are not expected to meet the MRI criteria for inclusion, up to 280 patients will be screened.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Minocycline
Minocycline 100 mg oral for up to 24 months
Minocycline
100 mg twice daily to be taken for up to 2 years
Placebo
Lactose Monohydrate NF (Spray-dried) 235 mg/cap Magnesium Stearate NF 1 mg/cap Croscarmellose Sodium NF 4 mg/cap Stearic Acid 10 mg/cap Placebo CAP Lt orange OP-Purple OP (APO 100)
Placebo
placebo twice daily for 2 years
Interventions
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Minocycline
100 mg twice daily to be taken for up to 2 years
Placebo
placebo twice daily for 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Multiple Sclerosis Society of Canada
OTHER
Dr. Luanne Metz
OTHER
Responsible Party
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Dr. Luanne Metz
Principal Investigator
Principal Investigators
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Luanne Metz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary, Calgary Health Region
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia, Canada
UBC Hospital
Vancouver, British Columbia, Canada
MS Research Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada
Dalhousie MS Research Unit
Halifax, Nova Scotia, Canada
MS Clinic, London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, Multiple Sclerosis Research Clinic
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
CHUM Notre-Dame
Montreal, Quebec, Canada
CHAUQ Enfant-Jesus
Québec, Quebec, Canada
Countries
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References
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Camara-Lemarroy C, Metz L, Kuhle J, Leppert D, Willemse E, Li DK, Traboulsee A, Greenfield J, Cerchiaro G, Silva C, Yong VW. Minocycline treatment in clinically isolated syndrome and serum NfL, GFAP, and metalloproteinase levels. Mult Scler. 2022 Nov;28(13):2081-2089. doi: 10.1177/13524585221109761. Epub 2022 Jul 18.
Metz LM, Li DKB, Traboulsee AL, Duquette P, Eliasziw M, Cerchiaro G, Greenfield J, Riddehough A, Yeung M, Kremenchutzky M, Vorobeychik G, Freedman MS, Bhan V, Blevins G, Marriott JJ, Grand'Maison F, Lee L, Thibault M, Hill MD, Yong VW; Minocycline in MS Study Team. Trial of Minocycline in a Clinically Isolated Syndrome of Multiple Sclerosis. N Engl J Med. 2017 Jun 1;376(22):2122-2133. doi: 10.1056/NEJMoa1608889.
Kang H, Metz LM, Traboulsee AL, Eliasziw M, Zhao GJ, Cheng Y, Zhao Y, Li DK; Minocycline in CIS Study Group. Application and a proposed modification of the 2010 McDonald criteria for the diagnosis of multiple sclerosis in a Canadian cohort of patients with clinically isolated syndromes. Mult Scler. 2014 Apr;20(4):458-63. doi: 10.1177/1352458513501230. Epub 2013 Aug 22.
Other Identifiers
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Health Canada Control #120007
Identifier Type: OTHER
Identifier Source: secondary_id
Grant ID # 21569
Identifier Type: -
Identifier Source: org_study_id
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