CompletedPhase 2Relapsing MSNCT00390221

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Adjusted Annualized Relapse Rate Between Baseline and Week 52Rate Ratio 0.4610.318–0.668<0.0001
Adjusted Annualized Relapse Rate Between Baseline and Week 52Rate Ratio 0.5030.352–0.7210.0002

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Adjusted Annualized Relapse Rate Between Baseline and Week 52

Baseline through Week 52

GroupValueIntervalNumber analysed
Placebo0.458 relapses per person-years0.37–0.566196
150 mg DAC HYP0.211 relapses per person-years0.155–0.287201
300 mg DAC HYP0.230 relapses per person-years0.172–0.308203

Placebo

0.458

150 mg DAC HYP

0.211

300 mg DAC HYP

0.23

p = <0.0001; Rate Ratio 0.461 (95% CI 0.318–0.668)

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo20453 (26.0%)
150 mg DAC HYP20832 (15.4%)
300 mg DAC HYP20936 (17.2%)
Total Active41768 (16.3%)

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

  • Adjusted Annualized Relapse Rate Between Baseline and Week 52

    Baseline through Week 52

    Relapses

Other measures (4)

  • Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24

    Week 8 through Week 24

    MRI lesions
  • Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52

    Week 52

    MRI lesions
  • Proportion of Participants Who Relapsed at Week 52

    Week 52

    Relapses
  • Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52

    Baseline and Week 52

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 55

Key Inclusion Criteria: * Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria: * Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR * Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization. Key Exclusion Criteria: * Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS * History of malignancy * History of severe allergic or anaphylactic reactions or known drug hypersensitivity * History of abnormal laboratory results based on investigator judgment * History of human immunodeficiency virus (HIV) or other immunodeficient conditions * History of drug or alcohol abuse within the 2 years prior to randomization * An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization * Positive screening for active infection with Hepatitis B virus or Hepatitis C virus * Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening * Exposure to varicella zoster virus within 21 days before Screening. * Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

About this trial

In the sponsor's words

The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Feb 2008

    2. Main results due

      May 2011

    3. Finished

      Aug 2011

    4. Results posted

      Jul 2016

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