Skip to content

Randomised Controlled Trial of Adrenocorticotropic hormone and Magnesium for Infantile Spasms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78654111
Enrollment
40
Registered
2007-07-16
Start date
2007-03-30
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child neurology, epilepsy Nervous System Diseases Infantile spasms

Interventions

Patients will be randomised into one of three groups: 1. ACTH 25 IU/d and 10% Glucose fluid for Venous transfusion (GV) 100 ml (continued for greater than four hours) for three weeks 2. Magnesium S

Sponsors

Beijing Children?s Hospital (China)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
1. EEG changes: close to normal, measured at day zero, one week, two weeks, three weeks, one month, three months and six months 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 3. Neuron-Specific Enolase (NSE) levels were measured at day zero, one month, three months and six months 4. Gesell Development Scale at day zero and six months

Primary

MeasureTime frame
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.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026