Trial · NCT01910259
MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial
NCT01910259, Phase 2, Completed, University College, London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial. Trials, record NCT01910259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01910259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial
- NCT number
- NCT01910259
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 445 participants, actual
- Lead sponsor
- University College, London
- Conditions
- Secondary Progressive Multiple Sclerosis
- Interventions
- Amiloride, Riluzole, Fluoxetine, Placebo
- First posted
- 2013-07-29
- Last updated
- 2020-03-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MRI-derived Percentage Brain Volume Change (PBVC). | 2 years | To establish whether a drug, from a panel of 3 leading candidate neuroprotective drugs, slows the rate of brain volume loss in SPMS over 96 weeks using MRI-derived percentage brain volume change (PBVC). |
| Secondary | Multi-arm trial strategy assessment | 2 years | To establish that a multi-arm trial strategy is an efficient way of screening drugs in SPMS and can become the template for future work. |
| Secondary | Count of new and enlarging T2 lesions | 2 years | To explore any anti-inflammatory drug activity using the count of new and enlarging T2 lesions. |
| Secondary | Pseudo-atrophy | 6 months | Examining for evidence of pseudo-atrophy (to ensure reliability of the primary outcome measure). |
| Secondary | Clinical measure of neuroprotection | 2 years | To examine the clinical effect of neuroprotection as measured by clinician - EDSS, MSFC, SDMT, SLCVA, relapse rate and patient reported outcome measures - MSIS29 v2, MSWS v2, Pain - NPRS and BPI and Fatigue - NFI. |
| Secondary | Health economics | 2 years | To collect basic health economic data (EQ-5D) to inform future phase III trials. |
| Other | New T1 hypotense lesion count | 2 years | Persistent new T1 hypointense lesion count to assess neuroprotection in new lesions. |
| Other | Grey matter volume change | 2 years | Grey matter volume change to assess cortical neuroprotection. |
| Other | MR spectroscopy measured N-acetyl aspartate, myoinositol and glutamate | 2 years | MR spectroscopy (MRS) to measure N-acetyl aspartate (reversal of neuronal mitochondrial dysfunction), myoinositol (prevention of glial cell inflammation) and glutamate (prevention of excitotoxicity). |
| Other | Myelination | 2 years | Magnetic Transfer Ratio (MTR) to evaluate myelination. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
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.
Papers4
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/NCT01910259
GET https://conductscience.org/api/trials/v1/NCT01910259/registered