Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)
Information source: University of Calgary
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clinically Isolated Syndromes; Early Single Relapse of Multiple Sclerosis
Intervention: Apo-Minocycline (Drug); Placebo Comparator (Drug)
Phase: Phase 3
Sponsored by: Dr. Luanne Metz
Official(s) and/or principal investigator(s):
Luanne Metz, MD, Principal Investigator, Affiliation: University of Calgary
Luanne Metz, Doctor, Phone: 403-944-4241, Email: firstname.lastname@example.org
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
Official title: A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: To confirm that this early treatment benefit is maintained at two years.
- Minocycline 100 mg bid orally compared to identical placebo
- Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event
suggestive of multiple sclerosis
- 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
- Patients will be discontinued from the study when they convert to McDMS based on the
2005 McDonald definition.
- 12 active Canadian MS Clinics
- A total of 200 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.
Minimum age: 18 Years.
Maximum age: 60 Years.
- 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). The time between the first clinical event and
initiation of treatment is reasonably short to prevent loss of patients that convert
to MS early. While previous CIS studies required earlier enrolment but these studies
found that few (about 5 %) patients have a second relapse within 30-60 days of
enrolment so we do not expect this extension of the enrolment period to introduce
- At least two lesions on the T2-weighted brain MRI scan with a size of at least 3 mm,
at least one of which is ovoid or periventricular or infratentorial. MRI eligibility
will be determined centrally by the UBC MS/MRI Research Group.
- Sexually active women of child-bearing potential must agree to use adequate
- Written informed consent
- 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
Locations and Contacts
Luanne Metz, Doctor, Phone: 403-944-4241, Email: email@example.com
University of Calgary, Calgary Health Region, Calgary, Alberta T2N 4N1, Canada; Recruiting
Judy Wu, Phone: 403-944-2589, Email: Judy.Wu@albertahealthservices.ca
Michael Yeung, Doctor, Principal Investigator
University of Alberta, Edmonton, Alberta T6G 2G3, Canada; Recruiting
Leah White, Phone: 780-407-3928, Email: Leah.White@capitalhealth.ca
Pam Dumont, Phone: 780-407-1491, Email: firstname.lastname@example.org
Gregg Blevins, Principal Investigator
Fraser Health Multiple Sclerosis Clinic, Burnaby, British Columbia V5G 2X6, Canada; Recruiting
Galina Vorobeychik, Phone: 604-412-6405, Email: GVneuroMSclinic@shaw.ca
Tara Martin, Phone: 604-412-6405, Ext: 4, Email: Tara.Martin@fraserhealth.ca
Galina Vorobeychik, Principal Investigator
UBC Hospital, Vancouver, British Columbia V6T 2B5, Canada; Recruiting
Leila Lagroix, Phone: 604-822-1758, Email: email@example.com
Nancy Bogle, Phone: 604-822-0754, Email: firstname.lastname@example.org
Tony Traboulsee, Principal Investigator
MS Research Unit, Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada; Recruiting
Barbara Stanger, Phone: 204-787-2905, Email: email@example.com
James Marriott, Principal Investigator
Dalhousie MS Research Unit, Halifax, Nova Scotia B3H 1V7, Canada; Recruiting
Natasha Gormley, Phone: 9025-473-8387, Email: firstname.lastname@example.org
Trudy Campbell, Phone: 902-473-7947, Email: email@example.com
Virender Bhan, Principal Investigator
MS Clinic, Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada; Terminated
MS Clinic, London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting
Anne Howley, Phone: 519-685-8500, Ext: 35352, Email: firstname.lastname@example.org
Marcelo Krememchutzky, Principal Investigator
The Ottawa Hospital, Multiple Sclerosis Research Clinic, Ottawa, Ontario K1H 8L6, Canada; Recruiting
Carol Freedman, Phone: 613-737-8104, Ext: 2, Email: email@example.com
Dawn Carle, Phone: 613-737-8104, Ext: 2, Email: firstname.lastname@example.org
Mark Freedman, Principal Investigator
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Kathleen Carr, Phone: 416-480-4970, Email: Kathleen.Carr@sunnybrook.ca
Liesly Lee, MD, Principal Investigator
Clinique Neuro Rive-Sud, Greenfield Park, Quebec J4V2J2, Canada; Recruiting
Julie Lafreniere, Phone: 450-672-5221, Email: email@example.com
Christine Guerette, Phone: 450-672-5221, Email: firstname.lastname@example.org
Francois Grand'Maison, Principal Investigator
CHUM Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting
Melanie Bosse, Phone: 514-890-8000, Ext: 25968, Email: email@example.com
Renee Dubois, Phone: 514-890-8000, Ext: 25173, Email: firstname.lastname@example.org
Pierre Duquette, Principal Investigator
CHAUQ Enfant-Jesus, Quebec City, Quebec G1J 1Z4, Canada; Recruiting
Lucie Morel, Phone: 418-649-0252, Ext: 3559, Email: email@example.com
Stephanie Gormley, Phone: 418-649-0252, Ext: 3530, Email: firstname.lastname@example.org
Manon Thibault, Principal Investigator
Starting date: January 2009
Last updated: March 21, 2012