Data updated: May 26, 2026
SPRITAM (levetiracetam)
CNS
Approved 2015-07-31
3
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-07-31
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
SPRITAM Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
40 FDA actions from 2015 to 2025 · 2 indication expansions
Dec 2015 SUPPL Priority
Mfg
What SPRITAM Treats
3 FDA approvalsOriginally approved for its first indication in 2015 . Covers 3 distinct patient populations.
- Other (3)
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Clinical Trial Registry
66 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06866691 SEIZE-TBI | IRB00123210 | Ph 4 | recruiting | Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide |
| NCT01857934 results posted | NB2012 NCI-2013-00034 | Ph 2 | completed | Therapy for Children With Advanced Stage Neuroblastoma |
| NCT01345058 results posted | 2010-P-001630 | Ph 3 | completed | Add on Lacosamide Versus High Dose Monotherapy |
| NCT03875638 LeAD | 2019P000091 | Ph 2 | completed | Treating Hyperexcitability in AD With Levetiracetam |
| NCT05735717 | 2021LS061 | Ph 2 | recruiting | MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies |
| NCT07490769 LEVTID | SCTR25011502 | Ph 3 | recruiting | Levetiracetam Three Times Daily in Epilepsy |
| NCT06345495 | 2023-0899 NCI-2024-02814 | Ph 2 | recruiting | High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly |
| NCT06442748 LIBRA | 4385 | Ph 3 | recruiting | Short Versus Long-term Levetiracetam in Brain Tumors |
| NCT07284498 HIE | MDP.25.01.179 | Ph 4 | not yet recruiting | Treatment of Seizures in Neonate With HIE |
| NCT07239115 PREVENT | KY2025-213-02 | Ph 3 | not yet recruiting | Levetiracetam for Seizure Prevention After Brain Tumor Surgery |
| NCT04833907 CAN-GT | CAN-GT | Ph 1, Ph 2 | enrolling by invitation | rAAV-Olig001-ASPA Gene Therapy for Treatment of Children With Typical Canavan Disease |
| NCT06081283 results posted | 23-0157 | Ph 4 | terminated | Antiseizure Medication in Seizure Networks at Early Acute Brain Injury |
| NCT07220902 LEVMag | 1559 | Ph 3 | not yet recruiting | Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure |
| NCT07072624 E-PTS | AIIMS/IEC/2024/4889 IIRPIG-2023-0001210 | Ph 4 | recruiting | Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) |
| NCT03034356 results posted | MHBB-006-16S I01CX001414 | Ph 1, Ph 2 | completed | Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia |
| NCT07046611 KLaSSEC | Soh-Med-25-6-2PD | Ph 2, Ph 3 | recruiting | Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children |
| NCT06773364 EAST | 2024-228 | Ph 3 | recruiting | Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial |
| NCT02201251 results posted | CR104425 TOPMATEPY4067, 2012-001552-19 | Ph 3 | completed | A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy |
| NCT01228747 results posted | N01159 2014-004401-32 | Ph 3 | completed | A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures) |
| NCT03048084 STING | 77353 | Ph 4 | recruiting | Seizure Treatment in Glioma |
| NCT01801072 SPAR results posted | HUM00064523 | Ph 4 | completed | Seizure Prophylaxis in Aneurysm Repair |
| NCT05897658 LeviTaTe Pilot | 14147 | Ph 3 | not yet recruiting | Levetiracetam Prophylaxis in Brain Tumor Resection Pilot |
| NCT04643327 TRIP | HREC/2020/QRBW/69379 | Ph 2 | recruiting | Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease |
| NCT03340064 PEACH results posted | EP0100 | Ph 3 | completed | A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age |
| NCT02348216 ZUMA-1 results posted | KTE-C19-101 2015-005007-86 | Ph 1, Ph 2 | completed | Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma |
| NCT03489044 ILiAD | IRAS 203849 2016-003109-32 | Ph 2 | completed | An Investigation of Levetiracetam in Alzheimer's Disease |
| NCT03436433 results posted | Pro00081334 | Ph 2 | terminated | Seizure Prophylaxis in Patients With Glioma or Brain Metastasis |
| NCT03129360 results posted | 17-00266 | Ph 2 | completed | Levetiracetam in Early Psychosis |
| NCT04926844 | Soh-Med-21-06-07 | Ph 2 | completed | Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children |
| NCT02002819 LEV-AD results posted | NEUR-2017-25879 PCTRB-13-288476 | Ph 2 | completed | Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability |
| NCT03940326 results posted | LEVIGS | Ph 4 | completed | Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures |
| NCT02334722 results posted | IRB201400876 OCR14673 | Ph 4 | completed | 1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients |
| NCT01239212 results posted | 101335 | Ph 1, Ph 2 | completed | Dosing of Levetiracetam (Keppra) in Neonates |
| NCT01960075 ESETT results posted | 18078 119756, U01NS088034 | Ph 3 | completed | Established Status Epilepticus Treatment Trial |
| NCT04573803 MAST | A095460 | Ph 3 | not yet recruiting | Pharmacological Management of Seizures Post Traumatic Brain Injury |
| NCT04610879 CASTLE | CASTLE 2018-003893-29, RP-PG-0615-20007 | Ph 4 | terminated | Changing Agendas on Sleep, Treatment and Learning in Epilepsy |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT00489281 results posted | J0676 P30CA006973, P01CA015396 | Ph 2 | terminated | Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders |
| NCT00627133 | K17644 | Ph 2 | withdrawn | Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01464359 results posted | MT2011-15 | Ph 2 | terminated | T-Cell Depleted Double UCB for Refractory AML |
| NCT01521130 FIRST | R01NS065840-01 R01NS065840-01 | Ph 1 | completed | Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children |
| NCT01935908 SPLASH - Pilot | SPLASH-P1 | Ph 4 | withdrawn | Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study |
| NCT02602860 | EP0074 | Ph 1 | completed | A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers |
| NCT01891890 COPE results posted | IRB00066541 PCORI 527 | Ph 3 | terminated | Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) |
| NCT02726867 | MAES-003 | Ph 3 | withdrawn | Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus |
| NCT01375374 VICTOR results posted | SP0978 2010-022534-84 | Ph 3 | terminated | Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide |
| NCT01398956 results posted | N01361 | Ph 3 | completed | An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures |
| NCT01954121 results posted | N01364 | Ph 3 | completed | Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures |
| NCT01229735 results posted | N01353 | Ph 4 | completed | Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures |
Showing 50 of 66 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SPRITAM FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
7 international docs across 1 countries
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.