Registered outcomes15

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

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.
Secondary	Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15	Baseline, Month 15	Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.
Secondary	Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)	Baseline to Month 24	Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).
Secondary	Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.
Secondary	Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)	Baseline to Month 24	Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.
Other	Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)	Baseline up to Month 24	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Other	Active-Treatment Phase: Number of Participants With AEs	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Other	Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities	Baseline up to Week 24	Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\>=) 120 beats per minute (bpm) and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 millimeters of mercury (mmHg) and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
Other	Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Clinically significant vital signs abnormalities included: Pulse rate: \>=120 bpm and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 mmHg and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
Other	Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters	Baseline, Endpoint (Month 24)	ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
Other	Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)	ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
Other	Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry	Baseline up to Month 24	Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter \[U/L\]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter \[mg/L\]), pancreatic amylase (in U/L)\>=3 \* upper limit of normal (ULN); Fibrinogen \>=6 grams per liter (gm/L); Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L.
Other	Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\>=3 \* ULN; Fibrinogen \>=6 gm/L; Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \>=28 micromols per liter (micromols/L); Creatinine \>=117 micromols/L; Albumin \<=25 gm/L.
Other	Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values	Baseline up to Month 24	Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5 grams per deciliter (gm/dL) in males and \<=10 gm/dL in females; White blood cells (WBCs) count \<=2.5 and \>=21\10\^9 per liter (L); Absolute neutrophil count (ANC) \<=1.49\10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.
Other	Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values	Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase	Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5, \>=20 gm/dL in males, and \<=10, \>=18.5 gm/dL in females; WBCs count \<=2.5 and \>=21\10\^9 per L; ANC \<=1.49\10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.

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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