Randomised Controlled Trial of Adrenocorticotropic hormone and Magnesium for Infantile Spasms

Completed

• Conditions: Child neurology, epilepsy; Nervous System Diseases; Infantile spasms

• Registration Number: ISRCTN78654111
• Lead Sponsor: Beijing Children?s Hospital (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Primary or adjunctive therapy for infantile spasms; diagnostic criteria of International League Against Epilepsy (ILAE) greater than six spasms per day

Exclusion Criteria

1. Patients with no infantile spasms; diagnostic criteria of ILAE greater than six spasms per day
2. Patient has one of the following infections:
2.1. Septic infections
2.2. Pneumonias
2.3. Urinary/gastrointestinal infections
2.4. Chickenpox or measles
2.5. Arterial hypertension
2.6. Electrolyte disturbances

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure rate reduction: response to therapy was divided into the following categories: 29 - 0%, 69 - 30% and 99 - 70% reduction of spasms frequency as compared with baseline, and seizure-free status, respectively.

Secondary Outcome Measures

Name	Time	Method
1. EEG changes: close to normal, measured at day zero, one week, two weeks, three weeks, one month, three months and six months<br>2. Calcium (Ca), Magnesium (Mg) and Glucose (Glu) were measured at day zero, one week, two weeks, three weeks, one month, three months and six months<br>3. Neuron-Specific Enolase (NSE) levels were measured at day zero, one month, three months and six months<br>4. Gesell Development Scale at day zero and six months