Tiagabine adjunctive therapy in children with refractory epilepsy: a single-blind dose escalating study.

Abstract

Tiagabine, a specific gamma-aminobutyric acid-uptake inhibitor, has been shown to be reasonably well tolerated and efficacious as adjunctive treatment for partial seizures in adults and is now being investigated in children. This 4-month, single-blind study evaluated the tolerability, safety and preliminary efficacy of ascending doses (0.25-1.5 mg/kg/day) of tiagabine add-on therapy in 52 children over the age of 2 years with different syndromes of refractory epilepsy. Adverse events, mostly mild to moderate, were reported by 39% of children during the single-blind placebo period and by 83% of children during tiagabine treatment. The events predominantly affected the nervous system with asthenia (19%), nervousness (19%), dizziness (17%) and somnolence (17%) being the most common. Only three children (6%) withdrew because of adverse events. Tiagabine appeared to reduce seizures more in localisation-related epilepsy syndromes than in generalised epilepsy syndromes. Twenty-three patients with localisation-related epilepsy syndromes were included and 17 of these patients entered the fourth dosing period. The 17 patients had a median reduction of seizure rate in the fourth month of treatment of 33% compared with baseline. In comparison, 13 of 22 children with seven different generalised epilepsy syndromes entered the fourth dosing period with a median change of seizure rate of 0%. Two patients experienced single episodes of status epilepticus during treatment; both cases resolved. Tiagabine showed efficacy mainly in localisation-related syndromes and was well tolerated by most children in a group of very refractory patients and warrants further study in children with epilepsy.

• Authors: P Uldall, C Bulteau, S A Pedersen, O Dulac, K Lyby
• Journal: Epilepsy research (Epilepsy Res) Vol. 42 Issue 2-3 Pg. 159-68 (Dec 2000) ISSN: 0920-1211 [Print] Netherlands
• PMID: 11074188 (Publication Type: Journal Article)

Chemical References

• Anticonvulsants
• Nipecotic Acids
• Tiagabine

Topics

• Adolescent
• Anticonvulsants (administration & dosage, adverse effects, blood)
• Child
• Epilepsy (blood, drug therapy, psychology)
• Female
• Humans
• Male
• Nipecotic Acids (administration & dosage, adverse effects, blood)
• Prospective Studies
• Single-Blind Method
• Tiagabine