Trial · NCT02493725
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | [Safety] Expressed frequency and severity of incidence of AE/SAEs after treatment with investigational product. | 6 months | |
| Primary | [Efficacy] Proportion of subjects who reach a score of FG2 or lower on the Hughes functional grading scale at week 4（Response Rate） | 4 weeks | |
| Secondary | Proportion of subjects with improvement of one or more scores on the functional grading scale at each visit | 6 months | |
| Secondary | Proportion of subjects who are able to walk unaided (FG2 or lower) at each visit | 6 months | |
| Secondary | Duration required for improvement by at least one grade on the Hughes functional grading scale | 6 months | |
| Secondary | Proportion of subjects who reach FG1 or 0 at week 24 | 6 months | |
| Secondary | Change in the FG score between peak disability score and the scores at each visit | 6 months | |
| Secondary | Proportion of subjects with a clinically relevant improvement in the R-ODS score. An increase in the R-ODS score (0-48) converted to the centile metric score (0-100) by at least six points at each visit | 6 months | |
| Secondary | Proportion of subjects with a clinically relevant improvement in ONLS. (a decrease in the ONLS score from baseline by at least 1 point) at each visit | 6months | |
| Secondary | Proportion and frequency of subjects who require ventilatory support (F 5) | 4 weeks | |
| Secondary | Duration of ventilatory support | 8 weeks | |
| Secondary | Occurrence of relapse from the start of the IP(Investigational Product) administration period until the end of the post IP period | 2 years | |
| Secondary | Overall survival from the start of the IP administration period until the end of the post IP period (OS) | 6 months | |
| Secondary | Change in grip strength at each visit from baseline | 6 months | |
| Secondary | Change in results of the manual muscle test (MMT score) at each visit from baseline | 6 months | |
| Secondary | Change in the rate and results of below measures on the nerve conduction test parameter from baseline:Median and ulnar nerve 's CMAP amplitude, distal latency, F wave latency , SNAP amplitude, motor sensory nerve conduction velocity | 6 months | |
| Secondary | Change in vital capacity and % vital capacity at each visit from baseline | 6 months | |
| Secondary | Proportion of patients who undergo re-administration of IVIg | 6 months | |
| Other | Antiganglioside antibodies (Antibodies to GM1・GD1a・GalNAc-GD1a・GQ1b, and their complexes) | 6 months | |
| Other | Concentration of eculizumab in serum | 6 months |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02493725/registered