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| Sponsor: | University of Calgary |
|---|---|
| Collaborator: |
The Multiple Sclerosis Society of Canada |
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00666887 |
Purpose
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 McKenzie 403-944-2579 Nicole.McKenzie@albertahealthservices.ca | |
| Contact: Miles Webb 403-944-2589 miles.webb@albertahealthservices.ca | |
| Principal Investigator: Michael Yeung, Doctor | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2G3 | |
| Contact: Pam Dumont 780-407-1491 Pam.Dumont@capitalhealth.ca | |
| Contact: Leah White 780-407-3928 Leah.White@capitalhealth.ca | |
| Principal Investigator: Gregg Blevins | |
| 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: Tara Martin 604-412-6405 ext 4 Tara.Martin@fraserhealth.ca | |
| Principal Investigator: Galina Vorobeychik | |
| UBC Hospital | 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: Natasha Gormley 9025-473-8387 natashe.gormley@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 | |
| Sunnybrook Health Sciences Centre | Active, not recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| The Ottawa Hospital, Multiple Sclerosis Research Clinic | Active, not recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| CHUM Notre-Dame | Recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Contact: Vicky Thiffault 514-890-8000 ext 25968 vicky.thiffault.chum@ssss.gouv.qc.ca | |
| Contact: Renee Dubois 514-890-8000 ext 25173 renee.dubois.chum@ssss.gouv.qc.ca | |
| Principal Investigator: Pierre Duquette | |
| Clinique Neuro Rive-Sud | Recruiting |
| Greenfield Park, Quebec, Canada, J4V2J2 | |
| Contact: Julie Lafreniere 450-672-5221 jl.nrs@videotron.ca | |
| Contact: Christine Guerette 450-672-5221 cg.nrs@videotron.ca | |
| Principal Investigator: Francois Grand'Maison | |
| CHAUQ Enfant-Jesus | Active, not recruiting |
| Quebec City, Quebec, Canada, G1J 1Z4 | |
| Principal Investigator: | Luanne Metz, MD | University of Calgary |
More Information
| 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: | January 11, 2010 |
| ClinicalTrials.gov Identifier: | NCT00666887 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Multiple Sclerosis Clinically Isolated Syndrome Minocycline Placebo |
|
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 |