Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy

NCT01549288 | Withdrawn Phase 2

• 1 other identifier: RADIS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Infantile spasms comprise an infantile epileptic encephalopathy characterized by hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the treatment of this disorder remains difficult. The first-line options which include hormonal therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are effective in 60-70% of the patients. Hormonal therapy is considered the best available treatment. Vigabatrin being expensive and of limited availability is not a feasible option for most patients in our setting. Also, these are however associated with significant side effects, and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have also been evaluated; however these drugs are less effective than ACTH. The ketogenic diet (KD) is a high fat, low carbohydrate diet. It has been used for treatment of intractable childhood epilepsy. The KD has also been shown to be effective for intractable infantile spasms; often after ACTH and vigabatrin have failed. The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Preliminary data have shown efficacy in refractory infantile spasms. This diet is also ideal for resource-constraint settings with paucity of trained dieticians. Hence this study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in children with infantile spasms refractory to hormonal treatment in a randomized controlled trial.

Conditions

Infantile Spasms

Outcome Measures

Primary Outcomes (1)

• Proportion of children who achieved spasm freedom as per parental reports at 4 weeks

  4 weeks

Secondary Outcomes (1)

• Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks

  4 weeks

Study Arms (2)

modified Atkins diet

EXPERIMENTAL

Behavioral: modified Atkins diet

control arm

OTHER

the control arm continues the anti-epileptic drugs without any added dietetic input

Other: no dietetic input

Interventions

modified Atkins diet BEHAVIORAL

Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted

modified Atkins diet

no dietetic input OTHER

continuation of anti-epileptic medication without any dietetic input

control arm

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 9 months to 3 years
• Presence of epileptic spasms in clusters in child 9 months to \< 3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants), persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/benzodiazepine/vigabatrin/topiramate/zonisamide/ levetiracetam) for at least 4 weeks.

You may not qualify if:

• Children with known or suspected inborn error of metabolism, Patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following:
• a history of parental consanguinity,
• prior affected siblings,
• unexplained vomiting,
• intermittent worsening of symptoms,
• recurrent episodes of lethargy,
• altered sensorium, or
• ataxia,
• hepatosplenomegaly on examination
• With or without 2 or more of the following biochemical abnormalities:
• High blood ammonia (\> 80mmol/L),
• High arterial lactate (\> 2 mmol/L),
• metabolic acidosis (pH \< 7.2),
• hypoglycaemia (blood sugar \< 40 mg/dl),
• abnormal urinary aminoacidogram,

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IN (1)