Comparison of Efficacy between Original and Generic Levetiracetam for Acute Repetitive Convulsive Seizure or status Epilepticus

Comparison of Efficacy between Original and Generic Levetiracetam for Acute Repetitive Convulsive Seizure or Status Epilepticus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190513001

Enrollment

Unknown

Registered

2019-05-13

Start date

2018-04-25

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute repetitive seizures (ARS) is a term to describe a condition manifest by multiple seizures occurring over a relatively brief period of time &#45

Interventions

. Screening Phase: Physical Examination&#44

before the first Levetiracetam infusion. 2. Dose&#45

Loading Phase: The Dose&#45

Loading Phase of the study will consist of : On the first day of each dosing period&#44

patients will receive a single 30&#45

minutes IV infusion dose of Levetiracetam. Dose is recommended to comply with the approval posology according to the patient condition and physician decision. 3. An End&#45

of&#45

Treatment (EOT) After the first dose is received&#44

either at the end of the Maintenance Phase or earlier if the patient withdraws from the study. During the EOT Visit&#44

safety and efficacy assessments will be performed. ,. Screening Phase: Physical Examination&#44

safety and efficacy assessments will be performed.

Placebo Comparator Drug,Active Comparator Drug

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: . Patient in male or female ages over 18 year-old whom oral administration is temporality not feasible. 2. Be diagnosed as Acute Repetitive Convulsive Seizure or Status Epilepticus 3. Active seizure is unable to control in generalized tonic-clonic seizures(GTCs) patients . 4. Patients who have had nonresponse to Phenytoin, Sodiam Valpolate and benzodiazepine therapy. 5. Able and willing to provide written informed consent for study participation.

Exclusion criteria

Exclusion criteria: Patients with a history of adverse drug reaction to Levitracetam. 2.Being received both of Carbamazepine and Probenecid treatment at screening 3.Have history of Neutropenia or Neutrophil < 1,500 prior to participate into the study. 4.Female patient who in currently breastfeeding or pregnant at the enrolment date. 5. Patients with current or past history of depression or suicide.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of brand-name and generic 12 months EEG	—

Secondary

Measure	Time frame
To safety monitor between Original and Generic Levetiracetam for Acute Repetitive Convulsive Seiz 12 months EEG	—

Countries

Thailand

Contacts

Public ContactSomsak Tiamkao

Faculty of Medicine, Khonkean University

somtia@kku.ac.th0810504626

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026