Condition category
Nervous System Diseases
Date applied
30/03/2007
Date assigned
16/07/2007
Last edited
04/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Li-Ping Zou

ORCID ID

Contact details

Department of Neurology
Beijing Children’s 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-Ping’s 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

Sponsor information

Organisation

Beijing Children’s Hospital (China)

Sponsor details

c/o Professor Li-Ping Zou
Department of Neurology
The Capital University of Medical Sciences
Beijing
100045
China

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes