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Spasms, Infantile clinical trials

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NCT ID: NCT05279118 Active, not recruiting - Ketogenic Diet Clinical Trials

Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome

Start date: March 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT04727970 Active, not recruiting - Infantile Spasm Clinical Trials

Tricaprilin Infantile Spasms Pilot Study

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and efficacy of tricaprilin in subjects with infantile spasms. This is a single-arm, open-label, pilot study in up to 10 subjects with infantile spasms. Upon completion of the main phase, subjects who exhibit improvement in seizure control and who tolerate the compound will be offered continued use of the IMP until benefit-risk ratio is no longer favourable, in a one-year open-label extension phase, available to Australian participants only.

NCT ID: NCT01367964 Active, not recruiting - West Syndrome Clinical Trials

Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

PREVENT-WS
Start date: July 2011
Phase: N/A
Study type: Interventional

West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment with ACTH will prevent WS.