Trial · NCT02342704
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions | Up to Week 52 | |
| Secondary | Cumulative Number of New T1-Gd+ Lesions | Baseline, Week 4, Week 12, Week 24 | |
| Secondary | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24 | Baseline, Week 24 | As assessed by magnetic resonance imaging (MRI). |
| Secondary | Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52 | Baseline, Week 52 | As assessed by MRI. |
| Secondary | Cumulative Number of New or Enlarging T2 Lesions | Baseline, Week 24 | |
| Secondary | Proportion of Participants With No Evidence of Disease Activity (NEDA) | Up to Week 52 | NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions. |
| Secondary | Time to First Relapse | Up to Week 52 | A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. |
| Secondary | Cumulative Risk of Relapse | Up to Week 52 | A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. |
| Secondary | Time to Complete Recovery From First Relapse | Up to Week 52 | 12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks. |
| Secondary | Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24 | Baseline, Week 24 | The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. |
| Secondary | Change From Baseline in SDMT at Week 52 | Baseline, Week 52 | The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02342704/registered