Trial · NCT01487096
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
NCT01487096, Phase 2, Completed, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses. Trials, record NCT01487096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01487096
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
- NCT number
- NCT01487096
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 179 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Multiple Sclerosis
- Interventions
- Teriflunomide, Placebo (placebo for teriflunomide)
- First posted
- 2011-12-07
- Last updated
- 2012-10-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis) | 36 weeks | The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment. Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan. Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan. |
| Primary | Overview of Adverse Events [AE] | from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first | AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. |
| Secondary | MRI assessment: number of T1-enhancing lesions per scan | 36 weeks | T1-enhancing lesions included: * Newly enhancing T1 lesions: lesions enhanced on the current T1 scan but not enhanced in any previous T1 scan. * Persistently enhancing T1 lesions: lesions enhanced on the current T1 scan and enhanced on the previous T1 scan. |
| Secondary | MRI assessment: number of T2-lesions per scan | 36 weeks | T2-lesions included: * New T2-lesions: lesions that appeared on the current T2 scan but were not visible on any previous T2 scans. * Newly enlarging T2-lesions: lesions that appeared enlarged on the current T2 scan but were stable on the previous T2 scan. * Persistently enlarging T2-lesions: further enlarged lesions on the current T2 scan categorized as new or enlarging on the previous T2 scan. |
| Secondary | MRI assessment: Number of participants with no new lesions | 36 weeks | New lesions included new T2 lesions, new enhanced T1 lesions and unique newly active lesions. |
| Secondary | MRI assessment: Change from baseline in T2 burden of disease | 36 weeks | T2 burden of disease was defined as the total volume of all T2 lesions. |
| Secondary | Number of participants with progression on Expanded Disability Status Scale [EDSS] | 36 weeks | EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Progression was defined as an increase in EDSS score by at least 1-point when baseline EDSS score ≤5.5 or an increase in EDSS score by at least 0.5-point in when baseline EDSS score \>5.5. |
| Secondary | Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores. | 36 weeks | A relapse was defined as the appearance, reappearance or worsening of a symptom attributable to MS. The change had to persist for at least 48 hours in the absence of fever and be preceded by stability or improvement for at least 30 days. Relapses were to be confirmed by Scripps NRS and EDSS scores. NRS is a scale that qualifies the degree of impairment from a neurological exam of the following systems: mentation and mood, cranial nerves, motor nerves, deep tendon reflexes, sensory nerves, cerebellum, gait/trunk/balance, bladder/bowel/sexual dysfunction. NRS score ranges from 0 to 100 (lower degree of impairment). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01487096
GET https://conductscience.org/api/trials/v1/NCT01487096/registered