Disease × agent evidence record

Diazepam for Epilepsy: evidence, trials and status

Diazepam has both completed registered trials and synthesis-level publications linked to Epilepsy. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 0 recruiting 20 publications Evidence tier A · Strong Score 64.5
Research Tracker › Pairs › Epilepsy › Diazepam
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Diazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Epilepsy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Epilepsy. ClinicalTrials.gov lists 8 registered trials linking Diazepam to Epilepsy: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02474407). The largest enrolment is 584 participants (NCT03346382). Registration activity spans 2015 to 2023. The literature layer holds 20 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews, 4 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2014 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Epilepsy ranks 187 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 60-85% achieve seizure freedom on medication; of those, 50-75% remain seizure-free after withdrawal (varies by syndrome and duration of freedom).

Open in Repurposing ExplorerEpilepsy hubEpilepsy biomarkers & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score64.5 (trials 14.5, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other
Linked publications20 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 4 randomised controlled trial publications, 2 systematic reviews)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
Linked via biomarker / targetAARS1
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT03179891Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
2017
completedPhase 235
NCT02474407Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
2015
terminatedPhase 278
NCT02724423Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects
2016
completedPhase 157
NCT03346382Emergency Medical Services and Epilepsy in Switzerland
2015
completedNot applicable584
NCT03953820Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
2019
completedPHASE1, PHASE231
NCT02904265Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome
2016
terminatedPHASE2, PHASE33
NCT05361447Diazepam Trial in GAD65 Associated Epilepsy
2023
withdrawnPHASE1, PHASE2—
NCT03636958Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy
2021
withdrawnNot applicable—

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AARS1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Diazepam approved for Epilepsy?

Diazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Epilepsy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Epilepsy. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Diazepam in clinical trials for Epilepsy?

ClinicalTrials.gov lists 8 registered trials linking Diazepam to Epilepsy: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02474407). The largest enrolment is 584 participants (NCT03346382). Registration activity spans 2015 to 2023.

What does the evidence show for Diazepam in Epilepsy?

Diazepam has both completed registered trials and synthesis-level publications linked to Epilepsy. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AARS1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Diazepam for Epilepsy: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/epilepsy/diazepam.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.