A single-center, randomized, double blind, placebo-controlled, parallel-group, proof-of-concept trial to assess the efficacy and safety of ACT-1004-1239 in adults with progressive multiple sclerosis

Conditions

Progressive multiple sclerosis (MS)

Brief summary

Change from baseline to Week 24 in myelin water fraction (MWF) of the corpus callosum

Detailed description

Change from baseline to Week 24 in visual evoked potential (VEP) P100 latency, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (e.g., suicidal ideation and/or behavior based on the Columbia Suicide Severity Rating Scale [C-SSRS©]), AEs leading to premature discontinuation of trial intervention, Change from baseline to all assessed time points during the trial in: – vital signs – body weight – laboratory variables – electrocardiogram (ECG), Treatment-emergent marked abnormalities for: – vital signs – clinical laboratory variables – ECG

Related papers

No related papers found yet.

Interventions

DRUGACT-1004-1239 matching placebo

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 24 in myelin water fraction (MWF) of the corpus callosum	—

Secondary

Measure	Time frame
Change from baseline to Week 24 in visual evoked potential (VEP) P100 latency, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (e.g., suicidal ideation and/or behavior based on the Columbia Suicide Severity Rating Scale [C-SSRS©]), AEs leading to premature discontinuation of trial intervention, Change from baseline to all assessed time points during the trial in: – vital signs – body weight – laboratory variables – electrocardiogram (ECG), Treatment-emergent marked abnormalities for: – vital signs – clinical laboratory variables – ECG	—

Measure

Time frame

Change from baseline to Week 24 in visual evoked potential (VEP) P100 latency, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Concentrations of an undisclosed molecule (commercially confidential information) in CSF at Week 12 and at Week 24, normalized to labeled body water at Week 4, Treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest (e.g., suicidal ideation and/or behavior based on the Columbia Suicide Severity Rating Scale [C-SSRS©]), AEs leading to premature discontinuation of trial intervention, Change from baseline to all assessed time points during the trial in: – vital signs – body weight – laboratory variables – electrocardiogram (ECG), Treatment-emergent marked abnormalities for: – vital signs – clinical laboratory variables – ECG

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Countries

Netherlands

Outcome results

None listed