Clinical results and prospects for the use of phenosanic acid in patients with focal epilepsy

С. Г. Бурд; А. В. Лебедева; N V Pantina; Yu. V. Rubleva; Н. В. Пизова; С. В. Васильев; Anna N. Belova; Vorob'eva Ov; V. V Emelyanova; В. А. Жаднов; Н. Е. Иванова; Kalinin Vv; M. Ya. Kissin; С. В. Котов; Н. Е. Максимова; V A Mihajlov; А. Е. Новиков; И Е Повереннова; M. A. Yamin

doi:10.17116/jnevro202112110152

Key Points

To evaluate the efficacy and safety of the synthetic antioxidant phenosanic acid (Dibufelon) as an adjunctive treatment in patients with focal epilepsy.
Conducted a randomized, double-blind, placebo-controlled, parallel-group study in 120 patients with focal epilepsy receiving baseline antiepileptic drugs.
Tracked seizure frequency dynamics as the primary endpoint, specifically the proportion of patients achieving at least a 50% reduction in seizures.
Measured secondary outcomes including seizure-free days, bilateral tonic-clonic seizure frequency, cognitive function (FAB, MMSE), and emotional and life quality metrics (HADS, QOLIE-31-P, EQ-5D, VAS).
Phenosanic acid demonstrated a statistically significant advantage over placebo for the primary endpoint of reducing epileptic seizure frequency by at least 50% (numerical event rates not reported).
Secondary outcomes, including seizure-free days, bilateral tonic-clonic seizure dynamics, and cognitive and emotional rating scales, showed statistically significant improvements with phenosanic acid.
The treatment demonstrated a favorable safety profile and was well tolerated by patients.

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Implication

Randomized double-blind trial demonstrates reduced seizure frequency with adjunct phenosanic acid in focal epilepsy, indicating promising cognitive and emotional benefits.

Abstract

OBJECTIVE: To study the efficacy and safety of using a new original synthetic antioxidant - phenosanic acid as an adjunct therapy in patients with focal epilepsy. MATERIAL AND METHODS: A randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of phenosanic acid as an adjunct therapy to basic antiepileptic drugs in 120 patients with focal epilepsy. Primary purpose: to study the dynamic of seizure frequency. Secondary purposes: to study the dynamic of seizure-free days, the dynamics of bilateral tonic-clonic seizures, the results of questionnaires and scales (General Dynamics Assessment, Visual Analogue Scale (VAS), Quality of Life in Epilepsy (QOLIE-31-P), European Quality of Life Questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Frontal Asstssment Battery (FAB), Mini-Mental State Examination (MMSE)). RESULTS: Phenosanic acid (Dibufelon) showed statistically significant benefit over placebo in the primary indicator of efficacy (reduction in the frequency of epileptic seizures by at least 50%) and in the secondary indicators. The drug was safe and well tolerated by the patients. CONCLUSION: The addition of phenosanic acid (Dibufelon) to base antiepileptic drugs seems to be perspective because of its positive effect on reducing the number of epileptic seizures, as well as on comorbid disorders in the emotional and cognitive spheres.

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Бурд et al. (2021) studied this question.

synapsesocial.com/papers/6a938062273074d623e1baba https://doi.org/10.17116/jnevro202112110152

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Clinical results and prospects for the use of phenosanic acid in patients with focal epilepsy

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Clinical results and prospects for the use of phenosanic acid in patients with focal epilepsy

Key Points

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Implication

Abstract

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