[15]Meta-analysis (11 studies)2025
Devlikamova FI, Safina DR Zh Nevrol Psikhiatr Im S S Korsakova, 125(2):69-79 (2025)
Devlikamova FI, Safina DR. [Fonturacetam (Actitropil) in asthenia: systematic review and meta-analysis]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(2):69-79. doi: 10.17116/jnevro202512502169. PMID: 40047835.
Original source ↗ · doi:10.17116/jnevro202512502169 · PMID 40047835
- What it supports
- The first meta-analysis of the molecule: 11 studies, 549 patients with asthenia (mean age 45.9), all on 200 mg/day for one month; mean MFI-20 asthenia score fell 16.3 points (95% CI 8.85–23.85; p<0.0001); side-effect frequency averaged 5.5%, described as transient and regressing within a week of continued treatment.
- What it does not show
- A meta-analysis of mostly small, single-country (Russian) studies, published in the journal of record for the manufacturer’s market; the abstract reports no placebo-pooled estimate — treat the effect size with caution.
[16]Double-blind RCT · n=90 · MIXED2014
Grebeniuk OV, Zhukova NG, Alifirova VM Zh Nevrol Psikhiatr Im S S Korsakova, 114(11 Pt 2):27-31 (2014)
Grebeniuk OV, Zhukova NG, Alifirova VM. [The efficacy of add-on treatment with phenotropil in adult patients with locally-induced epilepsy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(11 Pt 2):27-31. doi: 10.17116/jnevro201411411227-31. PMID: 25591651.
Original source ↗ · doi:10.17116/jnevro201411411227-31 · PMID 25591651
- What it supports
- The ONLY double-blind placebo-controlled trial of phenylpiracetam in the indexed literature: 90 adults with symptomatic locally-induced epilepsy, phenotropil 100 or 200 mg versus placebo added to standard antiepileptics; seizure frequency and cognition improved in patients without epileptiform EEG abnormalities.
- What it does not show
- The mixed result is published in the abstract itself: the drug did not decrease the negative effects of standard antiepileptic therapy in 40% of patients. One trial, one indication, one country.
[17]Open observational · n=11702014
Fedin AI, et al. (TRIUMPH program) Zh Nevrol Psikhiatr Im S S Korsakova (2014)
Fedin AI, et al. [TRIUMPH — phenotropil in chronic brain ischemia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014. PMID: 25726789.
Original source ↗ · PMID 25726789
- What it supports
- The largest dataset: 1,170 patients with chronic brain ischemia (age 45–65) treated with phenotropil 100 mg for 2–3 months in primary care; asthenia severity decreased significantly by the end of month 1 and held to month 3, with a greater than twofold reduction in symptom severity.
- What it does not show
- No control group, no blinding, no randomisation — an open observational programme; effect sizes from such designs run high on average.
[18]Controlled, non-randomised · n=4002010
Koval’chuk VV, et al. Zh Nevrol Psikhiatr Im S S Korsakova (2010)
Koval’chuk VV, et al. [Efficacy of phenotropil in the rehabilitation of stroke patients]. Zh Nevrol Psikhiatr Im S S Korsakova. 2010. PMID: 21626817.
Original source ↗ · PMID 21626817
- What it supports
- Four hundred ischemic-stroke patients: 200 received three courses of phenotropil 400 mg/day within complex rehabilitation over the year post-stroke versus 200 controls; restoration of neurologic function and activities of daily living reported significantly better in the main group (p<0.0001).
- What it does not show
- No randomisation or blinding stated in the abstract — a controlled but non-randomised comparison.
[19]Open-label · n=992005
Savchenko AIu, Zakharova NS, Stepanov IN Zh Nevrol Psikhiatr Im S S Korsakova (2005)
Savchenko AIu, Zakharova NS, Stepanov IN. [The phenotropil treatment of the consequences of brain organic lesions]. Zh Nevrol Psikhiatr Im S S Korsakova. 2005. PMID: 16447562.
Original source ↗ · PMID 16447562
- What it supports
- Ninety-nine patients with encephalopathy remote from stroke, brain trauma or glioma surgery, treated with phenotropil 200 mg/day for one month; reported improvements in pareses, motor coordination, memory, attention and mood, with an EEG normalisation trend.
- What it does not show
- No control group stated — an open-label, uncontrolled clinical report.
[20]Open controlled · TOLERANCE SIGNAL2014
Medvedev VE, Frolova VI, Epifanov AV Zh Nevrol Psikhiatr Im S S Korsakova (2014)
Medvedev VE, Frolova VI, Epifanov AV. [Phenotropil in cardiovascular patients with neurotic disorders]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014. PMID: 25403298.
Original source ↗ · PMID 25403298
- What it supports
- The waning-effect evidence: in an open comparative study in cardiovascular patients with mild neurotic, somatoform, stress and depressive disorders, “the effect (in particular anxiolytic one) of phenotropil decreased after 4–8 weeks of treatment” — the published signal behind the tolerance discussion. Tolerability was described as satisfactory.
- What it does not show
- An open study of 70 patients total; a waning effect over weeks, consistent with — but not proof of — stimulant tolerance.
[21]Open · n=752013
Savenkov AA, Badalian OL, Avakian GN Zh Nevrol Psikhiatr Im S S Korsakova (2013)
Savenkov AA, Badalian OL, Avakian GN. [Nootropics and antioxidants in the complex therapy of symptomatic posttraumatic epilepsy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2013. PMID: 23887448.
Original source ↗ · PMID 23887448
- What it supports
- Seventy-five patients with symptomatic focal posttraumatic epilepsy; phenotropil and mexidol within complex antiepileptic therapy; reported seizure reduction, cognitive and quality-of-life improvement, and no seizure aggravation of the kind typical of many nootropic drugs.
- What it does not show
- Design not stated in the abstract; appears open/observational; combination therapy confounds attribution.
[22]Controlled, non-randomised · n=612007
Bel’skaia GN, et al. Zh Nevrol Psikhiatr Im S S Korsakova (2007)
Bel’skaia GN, et al. [Complex treatment of epilepsy with phenotropil]. Zh Nevrol Psikhiatr Im S S Korsakova. 2007. PMID: 18379471.
Original source ↗ · PMID 18379471
- What it supports
- Thirty-one epilepsy patients on phenotropil 100 mg/day for two months added to standard antiepileptics versus thirty on antiepileptics alone; significant seizure decrease and EEG improvement reported in the main group.
- What it does not show
- No randomisation or blinding stated; small groups.
[23]Narrative review2024
Gromova OA, Torshin IY Zh Nevrol Psikhiatr Im S S Korsakova, 124(8):21-31 (2024)
Gromova OA, Torshin IY. [Pharmacological effects of fonturacetam (Actitropil) and prospects for its clinical use]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(8):21-31. PMID: 39269293.
Original source ↗ · PMID 39269293
- What it supports
- The rebranding-era review: surveys experimental and clinical work under the INN and the new Actitropil brand — cerebral ischemia, neurodegenerative disease, epilepsy, asthenia, mental disorders — claiming anxiolytic, antiasthenic, antidepressant, anti-inflammatory and anticonvulsant effects.
- What it does not show
- A narrative review, not a systematic one; claims are surveyed, not re-tested.
[24]Narrative review2023
Titova NV, et al. Zh Nevrol Psikhiatr Im S S Korsakova (2023)
Titova NV, et al. [Asthenia, mental fatigue and cognitive dysfunction]. Zh Nevrol Psikhiatr Im S S Korsakova. 2023. PMID: 37315240.
Original source ↗ · PMID 37315240
- What it supports
- A rationale review concluding that combination therapy of fonturacetam with a nicotinoyl-GABA/Ginkgo biloba preparation is “pathogenetically justified” — an argument from mechanism, cited here to show how the Russian literature frames the drug.
- What it does not show
- A pathogenetic-rationale argument, not trial data.
[25]Cochrane · class context · NULL2001
Flicker L, Grimley Evans G Cochrane Database Syst Rev, (2):CD001011 (2001)
Flicker L, Grimley Evans G. Piracetam for dementia or cognitive impairment. Cochrane Database Syst Rev. 2001;(2):CD001011. PMID: 11405971.
Original source ↗ · PMID 11405971
- What it supports
- The family context every honest carphedon page needs: for the parent compound piracetam, the Cochrane reviewers’ verbatim conclusion — “the evidence available from the published literature does not support the use of piracetam in the treatment of people with dementia or cognitive impairment. Although effects were found on global impression of change, no benefit was shown by any of the more specific measures.”
- What it does not show
- A piracetam review, not a phenylpiracetam one — no Cochrane review of phenylpiracetam exists; included as class context, not as a verdict on carphedon itself.