Randomised Controlled Trial of Adrenocorticotropic hormone and Magnesium for Infantile Spasms
| ISRCTN | ISRCTN78654111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78654111 |
| Secondary identifying numbers | 1 |
- 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
Scientific
Department of Neurology
Beijing Childrens Hospital
The Capital University of Medical Sciences
Beijing
100045
China
| Phone | +86 (0)10 6802 8401 ext 2314 |
|---|---|
| zouliping21@hotmail.com |
Study information
| Study design | Randomised controlled three group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adrenocorticotropic Hormone (ACTH) and magnesium |
| Primary outcome measure | 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 study start date | 30/03/2007 |
| Completion date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 40 cases |
| 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
100045
China
Sponsor information
Beijing Childrens Hospital (China)
Hospital/treatment centre
Hospital/treatment centre
c/o Professor Li-Ping Zou
Department of Neurology
The Capital University of Medical Sciences
Beijing
100045
China
"ROR" |
https://ror.org/04skmn292 |
|---|
Funders
Funder type
Government
The following are responsible for the payment of 50% of the costs to this trial:
No information available
The National Science Foundation of Beijing (China)
No information available
The Capital Development Foundation of Beijing (China)
No information available
The remaining 50% of the trial costs will be covered by the parents of the children in the study.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
