Infantile spasms including West syndrome Nervous System Diseases Infantile spasms including West syndrome
Conditions
Interventions
Hormonal treatment (either prednisolone or tetracosactide depot) alone versus combination of hormonal treatment and vigabatrin
Sponsors
Royal United Hospital Bath NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The clinical features of infantile spasms confirmed by the consultant in charge or his/her nominated deputy and an EEG that is hypsarhythmic or similar, compatible with the diagnosis of infantile spasms
Exclusion criteria
Exclusion criteria: 1. More than 72 hours has elapsed since the EEG was performed 2. More than 72 hours has elapsed since the clinical features were confirmed 3. Age less than two months or greater than one year and two months 4. A diagnosis or high risk of tuberous sclerosis 5. Known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanic macules, forehead fibrous plaque, shagreen patch, retinal phakoma or known polycystic kidneys 6. Previous treatment for infantile spasms other than a therapeutic trial of pyridoxine to exclude pyridoxine dependent seizures. Previous treatment for other seizure types is not a reason for exclusion. 7. Previous treatment (within the last 28 days) with vigabatrin or hormonal treatments 8. A contraindication to vigabatrin or hormonal treatments 9. A lethal or potentially lethal condition, other than infantile spasms, with a risk of death before 18 months of age 10. Doubt about the ability of the parents or guardians to know when the spasms stop 11. Unavailable for follow up to 18 months of age 12. Those enrolled in a concurrent trial that is still in the active phase 13. The language ability of the parents or guardians is such that they may not understand what is being requested of them 14. The language ability of the parents or guardians is such that it will not be possible to undertake the Vineland assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The main early outcome will be the cessation of spasms 2. The main late outcome will be development at 18 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absence of spasms on days 13 and 14 2. Electro-clinical outcome 3. Extended electro-clinical outcome 4. The number of consecutive days free of spasms preceding and including day 14 5. Adverse reactions 6. Epilepsy outcome at 18 months of age 7. Development at 42 months of age 8. Epilepsy outcome at 42 months of age | — |
Countries
New Zealand, United Kingdom
Outcome results
None listed