Relapse Remitting Multiple SclerosisPhase 2NCT00203112
Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
A Phase 2 study testing glatiramer acetate with minocycline in people with Relapse Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapse Remitting Multiple Sclerosis
- What is being tested?
- glatiramer acetate with minocycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months.
- Subjects must have a relapsing-remitting disease course.
- Subjects must have had at least 1 documented relapse within the last year prior to study entry.
- Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
- Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
- Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator.
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- Subjects must be between the ages of 18 and 50 years inclusive.
- Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
- Subjects must be willing and able to give written informed consent prior to entering the study.
Who cannot join
- Previous use of injectable glatiramer acetate.
- Previous use of cladribine.
- Previous use of immunosuppressive agents in the last 6 months.
- Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry.
- Use of interferon agents or minocycline within 4 months prior to the screening visit.
- Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
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- Previous total body irradiation or total lymphoid irradiation (TLI).
- Pregnancy or breast feeding.
- Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits.
- 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).
- A known history of sensitivity to mannitol.
- Contraindication to or known history of sensitivity to tetracyclines.
- A known history of sensitivity to gadolinium.
- Inability to successfully undergo MRI scanning.
About this study
Official title: 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).
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.
- Conditions
- Relapse Remitting Multiple Sclerosis
- Being tested
- glatiramer acetate with minocycline, Glatiramer acetate with placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glatiramer acetate with minocyclineDrug
Also called Copaxone®
Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
Glatiramer acetate with placeboDrug
Also called Copaxone®
Subcutaneous injection glatiramer acetate 20mg, with oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Glatiramer Acetate injection with oral minocycline | Active comparator | Glatiramer Acetate 20mg with oral minocycline 100mg Receives: Drug: glatiramer acetate with minocycline |
| Glatiramer Acetate with placebo | Experimental | Glatiramer acetate injection 20mg with oral placebo Receives: Drug: Glatiramer acetate with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Assessment of tolerability and safety
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapse Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Godin, MD, Study director, Teva Neuroscience Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203112
- Sponsor's protocol ID
- GA 9014
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT00203112
- Acronym / sponsor ID
- GA 9014
- Conditions
- Relapse Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glatiramer Acetate injection with oral minocycline | Active comparator | Drug: glatiramer acetate with minocyclineGlatiramer Acetate 20mg with oral minocycline 100mg |
| Glatiramer Acetate with placebo | Experimental | Drug: Glatiramer acetate with placeboGlatiramer acetate injection 20mg with oral placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months.
- Subjects must have a relapsing-remitting disease course.
- Subjects must have had at least 1 documented relapse within the last year prior to study entry.
- Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
- Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
Key exclusion criteria (14 listed)
- Previous use of injectable glatiramer acetate.
- Previous use of cladribine.
- Previous use of immunosuppressive agents in the last 6 months.
- Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry.
- Use of interferon agents or minocycline within 4 months prior to the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glatiramer acetate with minocyclineAlso: Copaxone®Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg | Drug | Glatiramer Acetate injection with oral minocycline |
| Glatiramer acetate with placeboAlso: Copaxone®Subcutaneous injection glatiramer acetate 20mg, with oral placebo | Drug | Glatiramer Acetate with placebo |
Primary outcome
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
1 secondary outcome
Assessment of tolerability and safety
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
- Results publication: PubMed 19776092Metz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Godin, MD study director
Teva Neuroscience Canada
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glatiramer acetate with minocycline in people with Relapse Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011.