Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome

Conditions

Lennox-Gastaut Syndrome

Brief summary

Percent change in CMMS-28 from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase)

Detailed description

Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 seizure-free days from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), CGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-CSID score at the end of the DB Period (Titration plus Maintenance Phase), Change in QI-disability score from Baseline to the end of the DB Period (Titration plus Maintenance Phase), Percent change per 28 days in the number of seizure-free days (based on all seizure types) from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only, Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only, Incidence of TEAEs

Related papers

No related papers found yet.

Interventions

DRUGClemizole Hydrochloride placebo

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase)	—

Secondary

Measure	Time frame
Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 seizure-free days from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), CGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-CSID score at the end of the DB Period (Titration plus Maintenance Phase), Change in QI-disability score from Baseline to the end of the DB Period (Titration plus Maintenance Phase), Percent change per 28 days in the number of seizure-free days (based on all seizure types) from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only, Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period	—

Measure

Time frame

Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 seizure-free days from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), CGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-C score at the end of the DB Period (Titration plus Maintenance Phase), CaGI-CSID score at the end of the DB Period (Titration plus Maintenance Phase), Change in QI-disability score from Baseline to the end of the DB Period (Titration plus Maintenance Phase), Percent change per 28 days in the number of seizure-free days (based on all seizure types) from the Baseline Period through the end of the DB Period (Titration plus Maintenance Phase), Percent change in CMMS-28 from the Baseline Period through the end of the DB Maintenance Phase only, Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period

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Outcome results

None listed