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Minocycline in Clinically Isolated Syndromes (CIS)
This study is currently recruiting participants.
Verified by University of Calgary, April 2009
First Received: April 23, 2008   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: University of Calgary
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

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Minocycline Minocycline hydrochloride
U.S. FDA Resources
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)

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: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To confirm that this early treatment benefit is maintained at two years. [ Time Frame: 4.7 years ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666887

Contacts
Contact: Luanne Metz, Doctor 403-944-4241 lmetz@ucalgary.ca
Contact: Shelly A Jelinski 403-210-8719 sjelinsk@ucalgary.ca

Locations
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
Sponsors and Collaborators
University of Calgary
The Multiple Sclerosis Society of Canada
Investigators
Principal Investigator: Luanne Metz, MD University of Calgary
  More Information

No publications provided

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

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

Study placed in the following topic categories:
Anti-Bacterial Agents
Minocycline
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009