Relapse-Remitting Multiple SclerosisPhase 2NCT00202982
A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
A Phase 2 study testing glatiramer acetate 20 mg and glatiramer acetate 40 mg in people with Relapse-Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 20 sites in United States.
Trial summary
This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose. 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 20 mg and glatiramer acetate 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2003to Sep 2005
- 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 with disease duration (from onset) of at least 6 months.
- 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 must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
- Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide).
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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 inclusive.
- Subjects must be willing and able to give written informed consent prior to entering the study.
Who cannot join
- Previous use of glatiramer acetate (oral or injectable).
- 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/or participation in an investigational drug study within 6 months prior to study entry.
- Use of interferon agents within 60 days 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.
- Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
- Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
- A known history of sensitivity to mannitol.
- A known sensitivity to gadolinium.
- Inability to successfully undergo MRI scanning.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Clinical & Magnetic Resonance Research Ctr.
Albuquerque, New Mexico, 87131
The MS Center of Atlanta
Atlanta, Georgia
The Maryland Center for M.S.
Baltimore, Maryland
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Geisinger Medical Center
Danville, Pennsylvania, 17822
Michigan Institute of Neurological Disorders
Farmington Hills, Michigan, 48334
The Minneapolis Clinic of Neurology, LTD
Golden Valley, Minnesota, 55422
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Center for Neurologic Study
La Jolla, California, 92037
University of Tennessee
Memphis, Tennessee, 38163
University of Minnesota
Minneapolis, Minnesota, 55455
MSSM - Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029
Consultants in Neurology, Ltd
Northbrook, Illinois, 60062
North County Neurology Associates
Oceanside, California, 92056
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212
University of Rochester
Rochester, New York, 14642
VAMC
Salt Lake City, Utah, 84148
MS Hub Medical Group
Seattle, Washington, 98101
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Neurology & Neurosurgery
Tacoma, Washington, 98405
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients
This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.
- Conditions
- Relapse-Remitting Multiple Sclerosis
- Being tested
- glatiramer acetate 20 mg, glatiramer acetate 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glatiramer acetate 20 mgDrug
glatiramer acetate 20 mg
glatiramer acetate 40 mgDrug
glatiramer acetate 40 mg
| Study group | Role | What they receive |
|---|---|---|
| glatiramer acetate 20 mg | Active comparator | glatiramer acetate 20 mg Receives: Drug: glatiramer acetate 20 mg |
| glatiramer acetate 40 mg | Active comparator | glatiramer acetate 40 mg Receives: Drug: glatiramer acetate 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9
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 startAug 2003
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffery Cohen, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202982
- Sponsor's protocol ID
- 9006
- Status last verified
- Jan 2010
- First submitted
- 12 Sep 2005
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT00202982
- Acronym / sponsor ID
- 9006
- Conditions
- Relapse-Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (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 is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.
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 20 mg | Active comparator | Drug: glatiramer acetate 20 mgglatiramer acetate 20 mg |
| glatiramer acetate 40 mg | Active comparator | Drug: glatiramer acetate 40 mgglatiramer acetate 40 mg |
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 with disease duration (from onset) of at least 6 months.
- 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 must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
Key exclusion criteria (13 listed)
- Previous use of glatiramer acetate (oral or injectable).
- 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/or participation in an investigational drug study within 6 months prior to study entry.
- Use of interferon agents within 60 days 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 20 mgglatiramer acetate 20 mg | Drug | glatiramer acetate 20 mg |
| glatiramer acetate 40 mgglatiramer acetate 40 mg | Drug | glatiramer acetate 40 mg |
Primary outcome
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9
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 14 Jan 2010.
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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.
Jeffery Cohen, MD study chair
The Cleveland Clinic
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glatiramer acetate 20 mg and glatiramer acetate 40 mg in people with Relapse-Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 20 sites in United States.
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 13 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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2010.