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Trial · NCT03487263

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-emergent adverse events (safety, tolerability)one monthNumber of participants with treatment-emergent adverse events (safety, tolerability) classified by MedDRA
SecondaryTreatment-related change in ALSFRS-R functional scaleone monthTreatment-related change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) \[0 (worst) to 48 (best)\]
SecondaryRespiratory functionone monthTreatment-related change in percent normal Forced Vital Capacity \[0% (worst) to 100% (best)\]
SecondaryMuscle functionone monthTreatment-related change in percent normal Sniff Nasal Pressure \[0% (worst) to 100% (best)\]
SecondaryQuality of life measured by ALSSQOLone monthTreatment-related change in Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R) \[0 (worst) to 460 (best)\]
SecondaryPatient-reported outcomeone monthTreatment-related change Edinburgh Cognitive and Behavioural Assessment Score (ECAS) \[0 (worst) to 136 (best)\]
SecondaryMaximum Plasma Concentration (Cmax)one monthMaximum serum IC14 concentration (micrograms per milliliter)
SecondaryArea Under the Curve (AUC)one monthArea Under the Curve for serum IC14 (microgram x hr/mL)
SecondaryMonocyte CD14 Receptor Occupancyone monthTreatment-related change in percent monocyte CD14 receptor occupancy as a pharmacodynamic marker
SecondaryUrinary p75 neurotrophin receptor (biomarker)one monthTreatment-related change in urinary concentration of urinary p75 neurotrophin receptor (NTR) (nanograms per milligram creatinine)
SecondaryNeurofilament (biomarker)one monthTreatment-related change in concentration of neurofilament (picograms per milliliter)
SecondaryAnti-drug antibodiesone monthDevelopment of human anti-monoclonal antibodies following treatment

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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GET https://conductscience.org/api/trials/v1/NCT03487263/registered