Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures (CARDIF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Charité Neurocure AG Flöel
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01370044
First received: May 20, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Febrile Seizure
Drug: Carbogen
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • number of patients which need Diazepam [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo inhalation


Secondary Outcome Measures:
  • number of severe adverse events [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
    safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting

  • manageability of the application assessed by the parents [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility)

  • changes in quality of life of the parents and children after use of study medication [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
    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)

  • contentment and anxiety of the parents [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: August 2012
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Verum arm receiving Carbogen
Drug: Carbogen
3 minutes administration of carbogen
Placebo Comparator: Placebo
Placebo arm receiving oxygen
Drug: Placebo
3 minutes administration of oxygen

  Eligibility

Ages Eligible for Study:   12 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • condition after febrile seizure
  • age 12 months to 5 years
  • written informed consent

Exclusion Criteria:

  • severe other organic disease
  • meningitis as possible cause for the cerebral seizure
  • neurologic disease or cerebral dysplasia
  • cerebrale seizures without fever in the medical history
  • hypersynchronic eeg activity
  • disorder of the respiratory tract (Asthma e.g.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370044

Contacts
Contact: Markus Schülke-Gerstenfeld +49 30 450 639 721 ncrc@charite.de

Locations
Germany
Charite University Berlin Recruiting
Berlin, Germany, 10107
Contact: Markus Schülke-Gerstenfeld    +49 30 450 639 721    ncrc@charite.de   
Principal Investigator: Markus Schülke-Gerstenfeld         
Sponsors and Collaborators
Charite University, Berlin, Germany
Charité Neurocure AG Flöel
Investigators
Principal Investigator: Markus Schülke-Gerstenfeld Charite - NeuroCure
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Markus Schülke-Gerstenfeld, Charite University Berlin
ClinicalTrials.gov Identifier: NCT01370044     History of Changes
Other Study ID Numbers: CARDIF
Study First Received: May 20, 2011
Last Updated: March 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Febrile Seizure
Carbon Dioxide
Carbogen
Respiratory Alkalosis

Additional relevant MeSH terms:
Seizures, Febrile
Fever
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Neurologic Manifestations
Carbogen
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014