Minocycline in Clinically Isolated Syndromes (CIS) (MinoCIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Multiple Sclerosis Society of Canada
Information provided by (Responsible Party):
Dr. Luanne Metz, University of Calgary
ClinicalTrials.gov Identifier:
NCT00666887
First received: April 23, 2008
Last updated: July 17, 2014
Last verified: July 2014
  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
Early Single Relapse of Multiple Sclerosis
Drug: Minocycline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To confirm that this early treatment benefit is maintained at two years. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 154
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minocycline
Minocycline 100 mg oral for up to 24 months
Drug: Minocycline
100 mg twice daily to be taken for up to 2 years
Other Names:
  • MINOCIN
  • Minocycline Hydrochloride
Placebo Comparator: 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)
Drug: Placebo
placebo twice daily for 2 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 (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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666887

Locations
Canada, Alberta
University of Calgary, Calgary Health Region
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia, Canada, V5G 2X6
UBC Hospital
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
MS Research Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Dalhousie MS Research Unit
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
MS Clinic, London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital, Multiple Sclerosis Research Clinic
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V2J2
CHUM Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CHAUQ Enfant-Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Dr. Luanne Metz
Multiple Sclerosis Society of Canada
Investigators
Principal Investigator: Luanne Metz, MD University of Calgary
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Luanne Metz, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT00666887     History of Changes
Other Study ID Numbers: Grant ID # 21569, Health Canada Control #120007
Study First Received: April 23, 2008
Last Updated: July 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Multiple Sclerosis
Clinically Isolated Syndrome
Minocycline
Placebo

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014