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Minocycline in Clinically Isolated Syndromes (CIS)

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clinically Isolated Syndromes; Early Single Relapse of Multiple Sclerosis

Intervention: Minocycline (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dr. Luanne Metz

Official(s) and/or principal investigator(s):
Luanne Metz, MD, Principal Investigator, Affiliation: University of Calgary

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) and Early Single Relapse Multiple Sclerosis (MS)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, 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.

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

University of Calgary, Calgary Health Region, Calgary, Alberta T2N 4N1, Canada

University of Alberta, Edmonton, Alberta T6G 2G3, Canada

Fraser Health Multiple Sclerosis Clinic, Burnaby, British Columbia V5G 2X6, Canada

UBC Hospital, Vancouver, British Columbia V6T 2B5, Canada

MS Research Unit, Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada

Dalhousie MS Research Unit, Halifax, Nova Scotia B3H 1V7, Canada

MS Clinic, London Health Sciences Centre, London, Ontario N6A 5A5, Canada

The Ottawa Hospital, Multiple Sclerosis Research Clinic, Ottawa, Ontario K1H 8L6, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Clinique Neuro Rive-Sud, Greenfield Park, Quebec J4V2J2, Canada

CHUM Notre-Dame, Montreal, Quebec H2L 4M1, Canada

CHAUQ Enfant-Jesus, Quebec City, Quebec G1J 1Z4, Canada

Additional Information

Starting date: January 2009
Last updated: July 13, 2015

Page last updated: August 23, 2015

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