Randomised Controlled Trial of Adrenocorticotropic hormone and Magnesium for Infantile Spasms

ISRCTN	ISRCTN78654111
DOI	https://doi.org/10.1186/ISRCTN78654111
Protocol serial number	1
Sponsor	Beijing Childrens Hospital (China)
Funders	The following are responsible for the payment of 50% of the costs to this trial:, The National Science Foundation of Beijing (China), The Capital Development Foundation of Beijing (China), The remaining 50% of the trial costs will be covered by the parents of the children in the study.

Submission date: 30/03/2007
Registration date: 16/07/2007
Last edited: 04/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Li-Ping Zou
Scientific

Department of Neurology
Beijing Childrens Hospital
The Capital University of Medical Sciences
Beijing
100045
China

Phone	+86 (0)10 6802 8401 ext 2314
Email	zouliping21@hotmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled three group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	RCTAMIS
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Adrenocorticotropic Hormone (ACTH) and magnesium
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/03/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Primary or adjunctive therapy for infantile spasms; diagnostic criteria of International League Against Epilepsy (ILAE) greater than six spasms per day
Key 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
Date of first enrolment	30/03/2007
Date of final enrolment	30/03/2007

Locations

Countries of recruitment

China

Study participating centre

Department of Neurology

Beijing
100045
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No