Clinical trial

Comparison of Efficacy of Ketogenic Diet and ACTH Therapy Among Children With West Syndrome: A Pilot Randomized Control Trial

Name

IECPG-19/27.1.2022,RT/24.2.22

Description

Children with West syndrome are prone to refractory seizures with poor neurocognitive outcome overall. The current standard of care consists of treatment with ACTH, but the grade of evidence is not high and not much RCTs are available. Ketogenic diet is an effective and well tolerated treatment option in drug refractory epilepsy and also in refractory west syndrome. In view of minimal side effects, better cost parameters and ability to continue for a longer duration our study aiims to investigate the efficacy of ketogenic diet as a first line therapy in comparison to ACTH therapy. Children with west syndrome after satisfying the inclusion and exclusion criteria will be randomised into the two treatment arms and primary response will be noted at the end of 6 weeks of therapy in terms of mean percentage of spasm reduction.

Trial arms

Trial start

2022-03-01

Estimated PCD

2024-03-28

Trial end

2024-03-28

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Ketogenic diet

Children who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed

Arms:

Ketogenic diet arm

Other names:

Diet therapy

ACTH

ACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks.

Arms:

ACTH arm

Other names:

Hormonal therapy

Size

Primary endpoint

Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms

From baseline to 6 weeks of therapy

Eligibility criteria

Inclusion Criteria: * Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome Exclusion Criteria: * Already on ACTH, prednisolone vigabatrin or KD therapy \> 5days * Tuberous sclerosis * Vitamin trial responsiveness * Known Pre-existing contraindications for KD (IEM, Porphyria etc.) * Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pilot randomized RCT', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-02-29

1 organization

1 product

4 indications

Organization

All India Institute of Medical Sciences

Product

Indication

Indication

Indication

Indication

Adrenocorticotropic hormone