Relapse Remitting Multiple SclerosisPhase 2NCT00203099
Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine
A Phase 2 study testing Glatiramer Acetate, N-Acetylcysteine in people with Relapse Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety. 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, N-Acetylcysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jun 2008
- 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 Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983).
- Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans.
- Subjects must have a relapsing-remitting disease course.
- Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10).
- 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 practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive 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 5.0 inclusive.
- Subjects must be willing and able to give written informed consent prior to entering the study.
Who cannot join
- Previous use of injected glatiramer acetate.
- Previous use of cladribine within 2 years prior to screening visit (week -10).
- Previous use of immunosuppressive agents in the last 6 months.
- Use of experimental or investigational drugs, including I.V. immunoglobulin, 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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- Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit.
- Previous total body irradiation or total lymphoid irradiation (TLI).
- Pregnancy or breastfeeding.
- 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 uncontrolled asthma.
- A known history of sensitivity to mannitol or acetylcysteine.
- Inability to successfully undergo MRI scanning.
About this study
Official title: A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)
This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.
- Conditions
- Relapse Remitting Multiple Sclerosis
- Being tested
- Glatiramer Acetate, N-Acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer Acetate, N-AcetylcysteineDrug
Subcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses.
| Study group | Role | What they receive |
|---|---|---|
| Glatiramer Acetate, N-Acetylcysteine | Active comparator | Not described Receives: Drug: Glatiramer Acetate, N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 [screening], -6 and 0 [baseline]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 [termination]).
Measured: 46 weeks
Secondary outcomes (1)
MRI parameters
Evaluation of secondary efficacy MRI parameters and assessments of tolerability and safety.
Measured: 46 Weeks
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 startDec 2004
- Primary completionAug 2006
- Study completionJun 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Godin, MD, Study director, Teva Neuroscience Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203099
- Sponsor's protocol ID
- GA 9015
- Status last verified
- May 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)
- ClinicalTrials.gov ID
- NCT00203099
- Acronym / sponsor ID
- GA 9015
- Conditions
- Relapse Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Jun 2008 (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 evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glatiramer Acetate, N-Acetylcysteine | Active comparator | Drug: Glatiramer Acetate, N-Acetylcysteine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Clinically Definite Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983).
- Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans.
- Subjects must have a relapsing-remitting disease course.
- Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10).
- 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 (13 listed)
- Previous use of injected glatiramer acetate.
- Previous use of cladribine within 2 years prior to screening visit (week -10).
- Previous use of immunosuppressive agents in the last 6 months.
- Use of experimental or investigational drugs, including I.V. immunoglobulin, 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, N-AcetylcysteineSubcutaneous glatiramer acetate 20 mg and concomitant oral administration of N-Acetylcysteine divided into two 2.5 g doses. | Drug | Glatiramer Acetate, N-Acetylcysteine |
Primary outcome
Change in the sum of T1 Gd-enhancing lesions as reflected by MRI
Time frame: 46 weeks
Change in the sum of T1 Gd-enhancing lesions measured at pre-treatment (weeks -10 [screening], -6 and 0 [baseline]) to the sum of T1 Gd-enhancing lesions measured in the last study trimester (weeks 28, 32 and 36 [termination]).
1 secondary outcome
MRI parameters
Time frame: 46 Weeks
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 May 2012.
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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, N-Acetylcysteine 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 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 May 2012. 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?
Change in the sum of T1 Gd-enhancing lesions as reflected by MRI (time frame: 46 weeks). 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 May 2012.