Safety and Efficacy Study of Copaxone Administered in Combination With
A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Compared with
- Glatiramer acetate
Unknown
Placebo
- Glatiramer acetate with placebo
What it measured
Main measures
To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images.
24 months
MRI lesions
Other measures (1)
Assessment of tolerability and safety
24 months
Safety
Who could take part
Relapsing MS · 18 to 50 · EDSS 0 to 5.0
Show the full criteria
Inclusion criteria
1. Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months. 2. Subjects must have a relapsing-remitting disease course. 3. Subjects must have had at least 1 documented relapse within the last year prior to study entry. 4. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. 5. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. 6. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator. 7. Subjects must be between the ages of 18 and 50 years inclusive. 8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive. 9. Subjects must be willing and able to give written informed consent prior to entering the study.
Exclusion criteria
1. Previous use of injectable glatiramer acetate. 2. Previous use of cladribine. 3. Previous use of immunosuppressive agents in the last 6 months. 4. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry. 5. Use of interferon agents or minocycline within 4 months prior to the screening visit. 6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry. 7. Previous total body irradiation or total lymphoid irradiation (TLI). 8. Pregnancy or breast feeding. 9. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits. 10. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). 11. A known history of sensitivity to mannitol. 12. Contraindication to or known history of sensitivity to tetracyclines. 13. A known history of sensitivity to gadolinium. 14. Inability to successfully undergo MRI scanning.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study investigates the add-on effect of oral minocycline in subjects treated with daily injection of Copaxone. Copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating MS symptoms.
Papers
Loading reviews and guidelines…
History
Started
Jun 2004
Main results due
Jun 2006
Finished
Jul 2006