Effectiveness of Semax in the acute period of hemispheric ischemic stroke (a clinical and electrophysiological study)
Gusev EI, Skvortsova VI, Miasoedov NF, Nezavibat'ko VN, Zhuravleva EIu, Vanichkin AV
Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova (1997) · n=110
The foundational Russian Semax stroke trial: 30 patients with acute hemispheric ischemic stroke received 12–18 mg/day intranasal Semax for 5–10 days added to combined intensive therapy and were compared to 80 conventionally treated controls — accelerated regression of motor and general cerebral deficits was the primary clinical finding, anchored by EEG mapping and somatosensory evoked potential correlates.
This 1997 Russian-language paper in Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova is the landmark trial that established Semax in the Russian clinical formulary as an adjunct for acute hemispheric ischemic stroke. The investigators — led by Evgeny Gusev and Veronika Skvortsova at the Russian State Medical University in Moscow, with the Ashmarin inventor group as co-authors — administered intranasal Semax at 12 mg/day for moderate-severity hemispheric stroke and 18 mg/day for severe stroke, for 5 and 10 days respectively, added to combined intensive therapy. The Semax cohort (n=30) was compared with a control cohort (n=80) of patients with strokes similar in severity and location who received conventional therapy alone. Clinical assessment used standardized rating scales for severity and neurological deficit; electrophysiological assessment used EEG mapping and somatosensory evoked potential analysis. The authors reported that Semax "had some influence on the rate of restoration of the damaged neurological functions in terms of increasing the regress of general cerebral and focal, especially motor disorders." The result is the foundational data behind Semax's inclusion on the Russian List of Vital and Essential Drugs for acute ischemic stroke since 1995-1997 and is the most-cited clinical trial in the broader Russian Semax stroke-rehabilitation literature that followed (Skvortsova 2004, Asanova 2005, and related publications).
This is not a randomized double-blind placebo-controlled trial. The design is a parallel-group comparison with non-randomized assignment, no blinding, no placebo arm, and unequal group sizes (n=30 active vs n=80 control). Effect-size statistics, p-values, and the specific quantitative deltas on the rating scales are not available in the English-language indexing of the paper and would require Russian-language full-text translation to verify. The trial is single-center, conducted by investigators whose group includes the molecule's inventors (Miasoedov, Nezavibat'ko), and the post-trial replication has occurred primarily within the Russian clinical-research network rather than via independently funded Western RCT replication. The Russian regulatory approval that followed reflects the Russian Federation's regulatory standards in the late 1990s, not a Western RCT-pivotal pathway. None of this means the trial is wrong — Semax is genuinely on the Russian formulary, the EEG biomarker corroboration is real, and the parallel-group design with electrophysiological co-measurement is more rigorous than a pure case-series — but the methodological standard sits one or two tiers below what would justify Western practitioner-grade recommendation. Editorial classification at Tier 2 reflects the peer-secondary status given the design.
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