Stopped earlyPhase 4Relapsing MSNCT00203047

What it found

Stopped: safety

The trial was stopped early for safety reasons.

Reason given: Slow enrollment decreased sample size; No unexpected safety issues.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method

Day 0, latest scan at month 24, 36 or early termination visit

GroupValueIntervalNumber analysed
GA + Placebo-0.46 percent change of baseline brain volume0.088 (Standard Error)105
GA + Prednisone-0.43 percent change of baseline brain volume0.106 (Standard Error)84

GA + Placebo

-0.46

GA + Prednisone

-0.43

p = 0.8023; Mean Difference (Final Values) -0.03 (95% CI -0.26–0.20)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
GA + Placebo19916 (8.0%)
GA + Prednisone20913 (6.2%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method

    Day 0, latest scan at month 24, 36 or early termination visit

    MRI lesionsBrain volume loss

Other measures (3)

  • Cumulative Number of Enhancing Lesions at Months 12, 24 and 36

    Months 12, 24, and 36

    MRI lesions
  • Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions

    Day 0, Month 36 or the early termination visit

    MRI lesions
  • Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions

    Day 0, Month 36 or early termination visit

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: 1. Clinically definite multiple sclerosis (CDMS) according to Poser (Ann. Neurol. 1983) or McDonald (Ann. Neurol. 2001) 2. Subjects eligible for GA treatment based on the investigator's clinical assessment and according to the current indication. 3. Subjects must have a relapsing remitting disease course. 4. Subjects must have had at least 1 documented relapse within the last year prior to study entry. 5. Subjects may be male or female. Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or intrauterine device [IUD] with spermicide), or partner's vasectomy. 6. Subjects must be between the ages of 18 and 55 years inclusive. 7. Subjects must be ambulatory, with a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.0 inclusive. 8. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: 1. Long-term glatiramer acetate users who have been on therapy within 6 months of the baseline magnetic resonance imaging (MRI). New glatiramer acetate users who have initiated therapy for more than 6 weeks prior to the baseline MRI. 2. Previous use of cladribine. 3. Previous use of mitoxantrone. 4. Use of digitalis at study entry. 5. Previous use of immunosuppressive agents (such as azathioprine, cyclophosphamide or mycophenolate mofetil) in the last 6 months prior to screening. 6. Use of experimental or investigational drugs, including intravenous (IV) immunoglobulin within 6 months prior to screening. 7. Use of interferon agents within 1 month prior to the baseline MRI. 8. Use of corticosteroids (IV, intramuscular [IM] and/or by mouth [PO]) within 30 days prior to the baseline MRI. 9. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to the screening visit. 10. Subjects with diabetes. 11. Previous total body irradiation or total lymphoid irradiation. 12. Pregnancy or breast feeding. 13. 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). 14. Other diseases that can cause brain atrophy (ex. neurodegenerative disorder, cerebrovascular disease, history of alcohol abuse). 15. Bone density less than -2.5 standard deviations (SD) (osteoporosis). 16. A known history of sensitivity to mannitol. 17. Contraindication to, or known history of, sensitivity or severe reaction to steroids. 18. A known history of sensitivity to gadolinium. 19. Inability to successfully undergo MRI scanning. 20. Previous use of natalizumab.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

Papers

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Related trials

History

    1. Started

      Jan 2005

    2. Main results due

      May 2009

    3. Finished

      May 2009

    4. Results posted

      Jan 2014

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