Levetiracetam: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Levetiracetam appears in the FDA drug-label database. Marketed as Levetiracetam.
FDA-approved use
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap — AuroMedics Pharma LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-03-27 |
| Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap — AuroMedics Pharma LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-03-27 |
| LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. — Dr. Reddy's Laboratories, Inc. | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2025-03-13 |
| Presence of foreign substance (screw) — Hetero Labs, Ltd. - Unit III | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2017-10-12 |
| CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed — Aurobindo Pharma USA Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-03-18 |
Phase breakdown
Conditions being studied
Recruiting trials involving Levetiracetam
- Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
- Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk
- Levetiracetam Three Times Daily in Epilepsy
- Levetiracetam for Seizure Prevention After Brain Tumor Surgery
- Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
- Precision Medicine in the Treatment of Epilepsy
- Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease
Common questions
Is Levetiracetam FDA-approved?
Yes, marketed as Levetiracetam.
How many recruiting trials involve Levetiracetam?
7 recruiting trials across 12 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.