Relapsing Remitting Multiple SclerosisPhase 2NCT00203073
A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
A Phase 2 study testing glatiramer acetate 20 mg and glatiramer acetate 20 mg, with mitoxantrone in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- glatiramer acetate 20 mg and glatiramer acetate 20 mg, with mitoxantrone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Apr 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
- 2.EDSS 0.0 - 6.5 inclusive
- 18 to 55 years of age
- 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
- Able and willing to sign and date an informed consent form
Who cannot join
- Patients ever treated with Glatiramer Acetate or Mitoxantrone.
- Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
- Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
- Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
- Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
- Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
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- Male patients and their partners must use contraceptive methods deemed reliable by the investigator
- LVEF < 50%
- Patients using catheters or Foley catheters
- Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy
- Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
- Abnormal screening blood tests exceeding any of the limits defined below:
- Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count < 2.3 x 103/uL Baseline neutrophil counts of < 1.5 x103/uL Platelet count < 80 x 103/uL Creatinine >1.5 mg/dL Prothrombin time greater than 150% upper limit of normal
- Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
About this study
Official title: A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.
It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- glatiramer acetate 20 mg, glatiramer acetate 20 mg, with mitoxantrone
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glatiramer acetate 20 mgDrug
Also called Copaxone
glatiramer acetate 20 mg
glatiramer acetate 20 mg, with mitoxantroneDrug
Also called Copaxone, Novantrone
glatiramer acetate 20 mg, with mitoxantrone
| Study group | Role | What they receive |
|---|---|---|
| Copaxone 20 mg | Active comparator | Copaxone 20 mg Receives: Drug: glatiramer acetate 20 mg |
| Copaxone 20mg with Novantrone induction | Active comparator | Copaxone 20mg with Novantrone induction Receives: Drug: glatiramer acetate 20 mg, with mitoxantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe
Measured: 15 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 2003
- Primary completionJan 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Siyu Liu, MD, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203073
- Sponsor's protocol ID
- NC-100
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00203073
- Acronym / sponsor ID
- NC-100
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Apr 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.
It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copaxone 20 mg | Active comparator | Drug: glatiramer acetate 20 mgCopaxone 20 mg |
| Copaxone 20mg with Novantrone induction | Active comparator | Drug: glatiramer acetate 20 mg, with mitoxantroneCopaxone 20mg with Novantrone induction |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
- 2.EDSS 0.0 - 6.5 inclusive
- 18 to 55 years of age
- 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
- Able and willing to sign and date an informed consent form
Key exclusion criteria (14 listed)
- Patients ever treated with Glatiramer Acetate or Mitoxantrone.
- Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
- Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
- Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
- Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
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 mgAlso: Copaxoneglatiramer acetate 20 mg | Drug | Copaxone 20 mg |
| glatiramer acetate 20 mg, with mitoxantroneAlso: Copaxone, Novantroneglatiramer acetate 20 mg, with mitoxantrone | Drug | Copaxone 20mg with Novantrone induction |
Primary outcome
Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe
Time frame: 15 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 14 Apr 2011.
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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.
Siyu Liu, MD study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glatiramer acetate 20 mg and glatiramer acetate 20 mg, with mitoxantrone in people with Relapsing 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 5 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 14 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?
Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe (time frame: 15 months). 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 Apr 2011.