Relapse Remitting Multiple Sclerosis MedDRA version: 8.0 Level: PT Classification code 10063399
Conditions
Interventions
Product Name: Minocycline 100 mg Film-coated Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Minocycline Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Merck AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, the subjects must fulfil all of the following criteria, within 30 days prior to the first trial day, which is defined as the first day of treatment with Minocycline or placebo: - The patient must give written informed consent prior to any trial related activities. - Trial related activities are any procedures that would not have been performed during normal management of the patient. - Has stable disease without relapses in the last 30 days. - Is between the age of 18 and 55 years (both included). - Suffers from definite relapsing-remitting MS according to Poser criteria (CDMS or LSDMS) or definite MS according to McDonald criteria. - Has started treatment with Rebif 44 mcg 3 months ago (± 1 month) including the titration phase. - Has a disability equivalent to an EDSS of 5.5 or less. - Has shown clinical activity defined as at least one documented relapse within the last year. - The patient must be prepared to and considered able to follow the protocol during the whole trial period and to attend the planned visits, even if the treatment has to be withdrawn. - A female must either be post-menopausal or surgically sterilized, or use a hormonal contraceptive or intra-uterine device, or be sexually inactive for the duration of the study and be neither pregnant nor breast-feeding. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this study the subjects must not meet any of the following criteria: - Any condition that might give rise to similar symptoms as MS. - Has received any other immunomodulatory or immunosuppressive treatment than Rebif six months prior to inclusion into the trial. - Has received mitoxantrone or total lymphoid radiation at any time. - Has received treatment with glucocorticoids or ACTH later than one month prior to inclusion into the trial. - Has experienced a relapse within one month prior to inclusion into the trial. - Has suffered from major depression. - Alcohol or drug dependency - Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhytmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg). - Has renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit. - ALAT and ASAT (or either one if only one of the two is measured) more than 2 times the normal upper reference limit. - Leucopoenia < 2500 per microl. or thrombopenia < 100000 per microl. - Any medical illness requiring treatment with systemic corticosteriods - Any systemic disease that can influence the patient’s safety and compliance, or the evaluation of the disability - Women who are pregnant or breastfeeding or who plan to become pregnant during the study. - Known or suspected allergy to minocycline or other tetracyclines. - Participation in any other studies, involving other investigational products, within 30 days prior to participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to eastimate the effect of Minocycline versus placebo in patients receiving treatment with interferon-beta-1a (IFN-beta-1a) on the time to the first documented relapse in patients with relapsing-remitting multiple sclerosis.;Secondary Objective: The secondary objectives are to estimate the effect of Minocycline versus placebo in patients receiving treatment with interferon-beta-1a on: - The mean number of relapses per patient up to year 2. And in a limited number of 120 patients: - The number of new or enlarging lesions on T2 weighted MRI - Brain atrophy measured on MRI.;Primary end point(s): The time to first documented relapse | — |
Countries
Finland, Sweden
Outcome results
None listed