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Trial · NCT03508453

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryNeurofilament (biomarker)12 weeksTreatment-related change in concentration of neurofilament (picograms per milliliter)
PrimaryUrinary p75 neurotrophin receptor (biomarker)12 weeksTreatment-related change in concentration of urinary p75 neurotrophin receptor (nanograms per milligram creatinine)
PrimaryMonocyte CD14 receptor occupancy12 weeksTreatment-related change in percent monocyte receptor occupancy
SecondaryFunctional status12 weeksTreatment-related change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale \[0 (worst) to 48 (best)\]
SecondaryRespiratory function12 weeksTreatment-related change in percent normal Forced Vital Capacity \[0% (worst) to 100%(best)\]
SecondaryMuscle function12 weeksTreatment-related change in percent normal Sniff Nasal Pressure \[0% (worst) to 100% (best)\]
SecondaryQuality of life measured by ALSSQOL12 weeksTreatment-related change in Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised questionnaire \[0 (worst) to 460 (best)\]
SecondaryCognitive and behavioural assessment12 weeksTreatment-related change in Edinburgh Cognitive and Behavioural Assessment Score \[0(worst) to 136 (best)\]
SecondaryMaximum plasma concentration (Cmax)12 weeksMaximum serum IC14 concentration (micrograms per milliliter)
SecondaryArea under the curve12 weeksArea under the curve for serum IC14 (microgram x hr/mL)
SecondaryImmunogenicity16 weeksDevelopment of human anti-monoclonal antibodies following treatment
SecondaryAdverse events (safety, tolerability)16 weeksIncidence of treatment-emergent adverse events (safety, tolerability) classified by MedDRA

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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