Minocycline in Clinically Isolated Syndromes (CIS)
Information source: University of Calgary
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clinically Isolated Syndromes; First Event of Multiple Sclerosis
Intervention: Apo-Minocycline (Drug); Placebo Comparator (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Calgary Official(s) and/or principal investigator(s):
Luanne Metz, MD, Principal Investigator, Affiliation: University of Calgary
Overall contact:
Luanne Metz, Doctor, Phone: 403-944-4241, Email: lmetz@ucalgary.ca
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 month follow-up period (primary outcome).
A key secondary outcome is to confirm that this early treatment benefit is maintained at two
years.
Clinical Details
Official title: A Phase III Double-Blind, Randomized, Placebo-Controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS)
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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.
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
- Men and women, aged 18-50y, first event within the previous 90 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.
- 24 months of study drug
- Subjects will be permitted to add approved MS disease modifying therapy of their choice
(at their own expense) after they reach McDMS.
- 14 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age between 18 and 50 years.
- First focal clinical episode suggestive of demyelinating disease within the previous
90 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
significant bias. On the other hand a 90 day enrolment period increases the
generalizability of the results and will improve recruitment.
- 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
contraception.
- Written informed consent
Exclusion Criteria:
- 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.
Locations and Contacts
Luanne Metz, Doctor, Phone: 403-944-4241, Email: lmetz@ucalgary.ca
University of Calgary, Calgary Health Region, Calgary, Alberta T2N 4N1, Canada; Recruiting
Nicole Anderson, Phone: 403-944-2579, Email: nicole2anderson@albertahealthservices.ca
Graziela Cerchiaro, Phone: 403-944-4315, Email: graziela.cerchiaro@albertahealthservices.ca
Michael Yeung, Doctor, Principal Investigator
University of Alberta, Edmonton, Alberta T6G 2G3, Canada; Active, not recruiting
Fraser Health Multiple Sclerosis Clinic, Burnaby, British Columbia V5G 2X6, Canada; Recruiting
Galina Vorobeychik, Phone: 604-412-6405, Email: GVneuroMSclinic@shaw.ca
Nicole Beauregard, Phone: 604-412-6405, Ext: 4, Email: nmbeau@shaw.ca
Galina Vorobeychik, Principal Investigator
UBC Hospital, Vancouver, British Columbia V6T 2B5, Canada; Recruiting
Shannon Mur, Phone: 604-822-0756, Email: Shanmuir@interchange.ubc.ca
Wendy Morrison, Phone: 604-822-7511
Tony Traboulsee, Principal Investigator
Dalhousie MS Research Unit, Halifax, Nova Scotia B3H 1V7, Canada; Recruiting
Judith Thompson, Phone: 9025-473-5539, Email: judith.thompson@cdha.nshealth.ca
Trudy Campbell, Phone: 902-473-7947, Email: trudy.campbell@cdha.nshealth.ca
Virender Bhan, Principal Investigator
MS Clinic, London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting
Anne Howley, Phone: 519-685-8500, Ext: 35352, Email: anne.howley@lhsc.on.ca
Shelley Cosma, Phone: 519-663-3744, Email: shelley.cosma@lhsc.on.ca
Marcelo Krememchutzky, Principal Investigator
MS Clinic, Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada; Active, not recruiting
CHUM Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Active, not recruiting
Clinique Neuro Rive-Sud, Greenfield Park, Quebec J4V2J2, Canada; Active, not recruiting
CHAUQ Enfant-Jesus, Quebec City, Quebec G1J 1Z4, Canada; Active, not recruiting
Additional Information
Starting date: January 2009
Ending date: December 2015
Last updated: May 28, 2009
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