Last reviewed · How we verify
Topiramate monotherapy
Topiramate is an anticonvulsant that enhances GABA-mediated inhibition and blocks sodium channels to reduce neuronal excitability.
Topiramate is an anticonvulsant that enhances GABA-mediated inhibition and blocks sodium channels to reduce neuronal excitability. Used for Epilepsy / seizure disorders (monotherapy and adjunctive therapy), Migraine prophylaxis, Essential tremor.
At a glance
| Generic name | Topiramate monotherapy |
|---|---|
| Sponsor | Johnson & Johnson Taiwan Ltd |
| Drug class | Anticonvulsant / Antiepileptic agent |
| Target | GABA-A receptor; voltage-gated sodium channels |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Topiramate potentiates the activity of the inhibitory neurotransmitter GABA at GABA-A receptors, thereby increasing neuronal inhibition. Additionally, it blocks voltage-gated sodium channels, which reduces repetitive neuronal firing. These dual mechanisms make it effective for seizure control and other neurological conditions.
Approved indications
- Epilepsy / seizure disorders (monotherapy and adjunctive therapy)
- Migraine prophylaxis
- Essential tremor
Common side effects
- Cognitive impairment / memory problems
- Paresthesia
- Weight loss
- Fatigue
- Dizziness
- Acute myopia / angle-closure glaucoma
- Metabolic acidosis
Key clinical trials
- Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (PHASE4)
- A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy (PHASE3)
- A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy (PHASE4)
- Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis (PHASE4)
- Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy (NA)
- First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients (PHASE4)
- A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Topiramate monotherapy CI brief — competitive landscape report
- Topiramate monotherapy updates RSS · CI watch RSS
- Johnson & Johnson Taiwan Ltd portfolio CI