Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

Infantile Spasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968136
• Other study ID #: 4-2006-0020
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: August 27, 2009

Study information

• Verified date: August 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial Summary

This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

1. Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.

2. Clinical and electroencephalography findings are compatible with infantile spasms

3. Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering).

4. Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.

Exclusion Criteria:

1. Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects.

2. Patients who have a history of nephrolithiasis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infantile Spasms
• Spasm
• Spasms, Infantile

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.		Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured.