CClinicalTrials.gg
CompletedNCT00203112Updated Apr 12, 2011

Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

A Phase 2 interventional study of glatiramer acetate with minocycline and Glatiramer acetate with placebo in Relapse Remitting Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-04-12.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Relapse Remitting Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Glatiramer Acetate injection with oral minocycline

    Glatiramer Acetate 20mg with oral minocycline 100mg

    Drug: glatiramer acetate with minocycline

  • Experimental
    Glatiramer Acetate with placebo

    Glatiramer acetate injection 20mg with oral placebo

    Drug: Glatiramer acetate with placebo

Interventions

  • Drugglatiramer acetate with minocycline

    Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg

    Also known as: Copaxone®

  • DrugGlatiramer acetate with placebo

    Subcutaneous injection glatiramer acetate 20mg, with oral placebo

    Also known as: Copaxone®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

Secondary outcomes

  1. Assessment of tolerability and safety

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW; GA/minocycline study investigators. Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial. Mult Scler. 2009 Oct;15(10):1183-94. doi: 10.1177/1352458509106779. Epub 2009 Sep 23. PubMed 19776092 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00203112
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
First posted
Sep 20, 2005
Start date
Jun 2004
Primary completion
Jun 2006
Completion
Jul 2006
Last update
Apr 12, 2011

Study contacts

Jean Godin, MD
study director · Teva Neuroscience Canada

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion