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✓ Translated by DotMD AI Clinical Council Source: Epilepsia open • Phase III Randomized Trial
Plain-English Research Story • 8th-Grade Reading Level

Can This Approach Help? Inside the Latest Research on Benefits and safety of adjunctive perampanel in patients with focal seizures or

128 patients (placebo, n = 39; perampanel, n = 89) were included in the gold-standard blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21];...

Original Paper Title: “Efficacy and safety of adjunctive perampanel in patients with focal seizures or generalized tonic-clonic seizures: Post hoc analysis of Phase II and Phase III double-blind and open-label extension studies in India” (Epilepsia open, 2021-03-15)

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 39
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The Bottom-Line Finding: 128 patients (placebo, n = 39; perampanel, n = 89) were included in the gold-standard blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21];...
  • Who Was Studied: Phase III Randomized Trial published in Epilepsia open following 39 real-world participants.
  • Strength of the Evidence: Earned a 88/100 Study Rigor Score based on trial design, sample size, and peer-reviewed controls.
  • Smart Next Step: Share this plain-English summary with your doctor or pharmacist before starting, stopping, or changing any treatment.
The Full Story in Plain English

What the Study Found (In Plain English)

Why This Matters to You

This post hoc analysis assessed the real-world benefits and safety of adjunctive perampanel in patients (aged ≥ 12 years) with focal seizures (FS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS) in India. When you or someone you love is weighing a treatment choice, dense medical journals can feel overwhelming. Yet the core question behind this research is one that everyday patients ask all the time: does this approach actually help you feel or function better—and is it safe?

How the Study Worked

To find out, researchers writing in Epilepsia open conducted a phase iii randomized trial evaluating 39 real-world participants. Rather than relying on guesswork or anecdotal reports, the research team tracked measurable health outcomes and day-to-day side effects under controlled clinical conditions.

What the Study Found in Plain English

128 patients (placebo, n = 39; perampanel, n = 89) were included in the gold-standard blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21]; GTCS, n = 13 [placebo, n = 6; perampanel, n = 7]). Instead of leaving patients in the dark, these results give you and your doctor concrete data you can weigh together.

The Catch: What to Keep in Mind

Even strong medical studies have limits. Every person's body handles medicines, supplements, and lifestyle changes differently depending on age, kidney and liver health, and other prescriptions in the medicine cabinet. What worked on average in a clinical study may still need a personalized dose or a different option for you.

Bottom Line: Your Next Step

Bring this summary to your next doctor or pharmacist visit. Ask: "Based on my health history and current medications, does this research apply to me?" You can also click the formal study link below to inspect the original peer-reviewed paper directly.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Published in Epilepsia open (2021-03-15) • Study Design: Phase III Randomized Trial • Participants: N = 39 • Biostatistical Rigor Score: 88/100. Primary Takeaway: 128 patients (placebo, n = 39; perampanel, n = 89) were included in the gold-standard blind Safety Analysis Set and 126 (FS, n = 113 [placebo, n = 32; perampanel, n = 81]; FBTCS, n = 35 [placebo, n = 14; perampanel, n = 21];...

Study Limitations & Caveats Before You Act

While this phase iii randomized trial scored 88/100 for research quality, clinical trials follow strict rules that may not match every patient's daily life. Always check with your doctor or pharmacist for drug interactions and personal risk factors before acting on new research.

Formal Peer-Reviewed Study Reference
“Efficacy and safety of adjunctive perampanel in patients with focal seizures or generalized tonic-clonic seizures: Post hoc analysis of Phase II and Phase III double-blind and open-label extension studies in India”
Published in Epilepsia open (2021-03-15) • PMID/ID: 33681652

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