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Sponsors and Collaborators: |
University of Calgary The Multiple Sclerosis Society of Canada |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00666887 |
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.
Condition | Intervention | Phase |
---|---|---|
Clinically Isolated Syndromes First Event of Multiple Sclerosis |
Drug: Apo-Minocycline Drug: Placebo Comparator |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Phase III Double-Blind, Randomized, Placebo-Controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1. Minocycline: Active Comparator
Drug, antibiotic Minocycline Hydrochloride
|
Drug: Apo-Minocycline
100 mg twice daily to be taken for 2 years
|
2 Placebo: Placebo Comparator
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)
|
Drug: Placebo Comparator
100 mg placebo twice daily for 2 years
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luanne Metz, Doctor | 403-944-4241 | lmetz@ucalgary.ca |
Contact: Shelly A Jelinski | 403-210-8719 | sjelinsk@ucalgary.ca |
Canada, Alberta | |
University of Calgary, Calgary Health Region | Recruiting |
Calgary, Alberta, Canada, T2N 4N1 | |
Contact: Nicole Anderson 403-944-2579 nicole2anderson@albertahealthservices.ca | |
Contact: Graziela Cerchiaro 403-944-4315 graziela.cerchiaro@albertahealthservices.ca | |
Principal Investigator: Michael Yeung, Doctor | |
University of Alberta | Active, not recruiting |
Edmonton, Alberta, Canada, T6G 2G3 | |
Canada, British Columbia | |
Fraser Health Multiple Sclerosis Clinic | Recruiting |
Burnaby, British Columbia, Canada, V5G 2X6 | |
Contact: Galina Vorobeychik 604-412-6405 GVneuroMSclinic@shaw.ca | |
Contact: Nicole Beauregard 604-412-6405 ext 4 nmbeau@shaw.ca | |
Principal Investigator: Galina Vorobeychik | |
UBC Hospital | Not yet recruiting |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Contact: Shannon Mur 604-822-0756 Shanmuir@interchange.ubc.ca | |
Contact: Wendy Morrison 604-822-7511 | |
Principal Investigator: Tony Traboulsee | |
Canada, Nova Scotia | |
Dalhousie MS Research Unit | Recruiting |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Contact: Judith Thompson 9025-473-5539 judith.thompson@cdha.nshealth.ca | |
Contact: Trudy Campbell 902-473-7947 trudy.campbell@cdha.nshealth.ca | |
Principal Investigator: Virender Bhan | |
Canada, Ontario | |
MS Clinic, London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Contact: Anne Howley 519-685-8500 ext 35352 anne.howley@lhsc.on.ca | |
Contact: Shelley Cosma 519-663-3744 shelley.cosma@lhsc.on.ca | |
Principal Investigator: Marcelo Krememchutzky | |
MS Clinic, Kingston General Hospital | Active, not recruiting |
Kingston, Ontario, Canada, K7L 2V7 | |
Canada, Quebec | |
CHUM Notre-Dame | Active, not recruiting |
Montreal, Quebec, Canada, H2L 4M1 | |
Clinique Neuro Rive-Sud | Active, not recruiting |
Greenfield Park, Quebec, Canada, J4V2J2 | |
CHAUQ Enfant-Jesus | Active, not recruiting |
Quebec City, Quebec, Canada, G1J 1Z4 |
Principal Investigator: | Luanne Metz, MD | University of Calgary |
Responsible Party: | University of Calgary, Hotchkiss Brain Institute ( Dr. Luanne Metz ) |
Study ID Numbers: | Grant ID # 21569, Health Canada Control #120007 |
Study First Received: | April 23, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00666887 History of Changes |
Health Authority: | Canada: Health Canada |
Multiple Sclerosis Clinically Isolated Syndrome Minocycline Placebo |
Anti-Bacterial Agents Minocycline Autoimmune Diseases Multiple Sclerosis |
Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Minocycline Autoimmune Diseases Disease Demyelinating Diseases Immune System Diseases Nervous System Diseases Sclerosis |
Pharmacologic Actions Anti-Bacterial Agents Multiple Sclerosis Pathologic Processes Therapeutic Uses Syndrome Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |