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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01549288
Other study ID # RADIS
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received March 6, 2012
Last updated April 7, 2013
Start date February 2012
Est. completion date December 2013

Study information

Verified date April 2013
Source Lady Hardinge Medical College
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 9 Months to 36 Months
Eligibility Inclusion Criteria:

1. age 9 months to 3 years

2. 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.

Exclusion Criteria:

- 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,

- presence of reducing sugars or ketones in urine, and

- positive results on urine neurometabolic screening tests. In such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (GCMS) will be obtained to look for inborn error of metabolism.

- Children with renal, pulmonary, cardiac or hepatic dysfunction

- Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts),

- Children from families who lack motivation will also be excluded as it might affect the compliance.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
modified Atkins diet
Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted
Other:
no dietetic input
continuation of anti-epileptic medication without any dietetic input

Locations

Country Name City State
India Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of children who achieved spasm freedom as per parental reports at 4 weeks 4 weeks No
Secondary Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks 4 weeks No
See also
  Status Clinical Trial Phase
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Completed NCT02885389 - Molecular Genetics in Infantile Spasms N/A
Completed NCT01006811 - Use of the Modified Atkins Diet in Infantile Spasms Phase 2/Phase 3
Completed NCT01828437 - Addition of Pyridoxine to Prednisolone in Infantile Spasms Phase 3
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Completed NCT00552045 - Epilepsy Phenome/Genome Project
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Completed NCT02954887 - Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) Phase 3
Completed NCT02092883 - Evaluation of Neuroinflammation in Children With Infantile Spasms Phase 4
Completed NCT01723787 - Genetic Studies in Patients and Families With Infantile Spasms
Withdrawn NCT01413711 - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Phase 4
Terminated NCT00442104 - Open-label Extension to Protocol 1042-0500 Phase 2
Completed NCT00441896 - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Phase 2
Completed NCT01575639 - Prednisolone in Infantile Spasms- High Dose Versus Usual Dose Phase 3
Not yet recruiting NCT06315829 - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Completed NCT01073579 - Sabril Patient Registry N/A
Completed NCT02953548 - Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) Phase 3
Completed NCT00001325 - Metabolic Abnormalities in Children With Epilepsy N/A
Completed NCT00968136 - Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study N/A