Lamotrigine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Lamotrigine appears in the FDA drug-label database. Marketed as Lamotrigine.
- Drug class
- Anti-epileptic Agent; Mood Stabilizer (FDA established pharmacologic class)
- Mechanism of action
- Organic Cation Transporter 2 Inhibitors; Dihydrofolate Reductase Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Lamotrigine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Lamotrigine orally disintegrating tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older : partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older : Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder : Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. — Taro Pharmaceuticals U.S.A., Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2019-12-20 |
| Presence of Foreign Substance consistent with granules from desiccant packs used during storage — AVKARE Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-05-28 |
| Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. — Unichem Pharmaceuticals Usa Inc | Class III (FDA: unlikely to cause harm) | Terminated | 2016-08-19 |
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. — Torrent Pharma Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-09-11 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Bipolar disorder | 2 |
| Bipolar Disorder Type I With Mania | 1 |
| Bipolar II Disorder | 1 |
| Epilepsy | 1 |
| Obesity | 1 |
| Obesity, Morbid | 1 |
| Pregnancy Related | 1 |
Recruiting trials involving Lamotrigine
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
- Bariatric Surgery and Pharmacokinetics of Lamotrigine
- Lithium Versus Lamotrigine in Bipolar Disorder, Type II
- Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Common questions
Is Lamotrigine FDA-approved?
Yes, marketed as Lamotrigine. Its FDA label carries a boxed warning.
How many recruiting trials involve Lamotrigine?
4 recruiting trials across 7 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.