Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

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.
Other	Cervical cord imaging	2 years	Cervical cord imaging to assess cord neuroprotection.
Other	Composite MRI/disability scores	2 years	Composite MRI/disability scores to increase sensitivity and study interaction of treatment mechanisms.
Other	Cerebrospinal fluid (CSF) neurofilament levels	2 years	Quantification of Cerebrospinal fluid (CSF) neurofilament levels to measure neuroprotection.
Other	Optical Coherence Tomography (OCT) measured Retinal Nerve Fibre Layer (RNFL) thickness	2 years	Optical Coherence Tomography (OCT) measured Retinal Nerve Fibre Layer (RNFL) thickness as a measure of neuroprotection.

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.

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