drugset / Trial / NCT01370044

Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

NCT01370044 ↗

Phase 2/3 Terminated 96 enrolled Charite University, Berlin, Germany
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo-inhalation. Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility), the quality of life of the parents and children using the low pressure can with a breathing mask in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.

Timeline

Start
2012-08
Primary completion
2015-06
Completion
2015-06

Outcome

Missed primary endpoint

Stopped: “results of interim analysis (not safety relevant)”

paper The febrile seizure was terminated in 5/15 episodes on carbogen and in 8/11 episodes on oxygen (Fischer's exact test; p = 0.11). PMID 41433250 ↗

paper In conclusion, carbogen did not interrupt acute febrile seizures more often than placebo. PMID 41433250 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbogen Other / unclassified 5 % Inhaled

Indications

No indication recorded.