Contact information
Type
Scientific
Primary contact
Prof Li-Ping Zou
ORCID ID
Contact details
Department of Neurology
Beijing Childrens Hospital
The Capital University of Medical Sciences
Beijing
100045
China
+86 (0)10 6802 8401 ext 2314
zouliping21@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
RCTAMIS
Study hypothesis
In this study it is hypothesised that magnesium sulphate in infantile spasms could lead to seizure rate reduction (seizure free rate) and a gradual improvement in background pattern of Electroencephalogram (EEG) (amplitude integrated Electroencephalogram [aEEG]).
Ethics approval
The Beijing Children Hospital Research Ethics Association is an independent, self-governing body of Research Ethics Committees, local and multi-centre, including their members and administrators. The Research Ethics Committee reviewed Dr Zou Li-Pings proposal for research on human subjects so as to protect them from undue risk or unethical research, while also encouraging research of high quality. Approval was received on the 1st December 2006.
Study design
Randomised controlled three group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Child neurology, epilepsy
Intervention
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 Sulphate (MgSO4) 250 mg/kg (1ml/kg) and 10％ GV (1％) (continued for greater than four hours) for three weeks. If no effect, change to group three for three weeks
3. ACTH and MgSO4: group one design and group two group design for three weeks
If we find that the patient has any of the infections mentioned in the exclusion criteria, the treatment will be stopped.
Intervention type
Drug
Phase
Not Specified
Drug names
Adrenocorticotropic Hormone (ACTH) and magnesium
Primary outcome measures
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
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
Overall trial start date
30/03/2007
Overall trial end date
30/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Primary or adjunctive therapy for infantile spasms; diagnostic criteria of International League Against Epilepsy (ILAE) greater than six spasms per day
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
40 cases
Participant 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
Recruitment start date
30/03/2007
Recruitment end date
30/03/2007
Locations
Countries of recruitment
China
Trial participating centre
Department of Neurology
Beijing
100045
China
Funders
Funder type
Government
Funder name
The following are responsible for the payment of 50% of the costs to this trial:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Science Foundation of Beijing (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Capital Development Foundation of Beijing (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The remaining 50% of the trial costs will be covered by the parents of the children in the study.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20435238
Publication citations
-
Results
Zou LP, Wang X, Dong CH, Chen CH, Zhao W, Zhao RY, Three-week combination treatment with ACTH + magnesium sulfate versus ACTH monotherapy for infantile spasms: a 24-week, randomized, open-label, follow-up study in China., Clin Ther, 2010, 32, 4, 692-700, doi: 10.1016/j.clinthera.2010.04.008.