Post traumatic seizures following traumatic brain injury MedDRA version: 20.0 Level: HLGT Classification code 10039911 Term: Seizures (incl subtypes) System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Levetiracetam
Product Name: Levetiracetam
Pharmaceutical Form:
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Concentration unit: g gram(s)
Concentration type: up to
Concent
Sponsors
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MAST-PROPHYLAXIS: 1. Patients aged aged =10 years with acute TBI managed in NSU without an acute seizure 2. Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient randomisation within 48 hours of admittance. MAST-DURATION: 1. Patients aged =10 years with TBI managed in an NSU who have started on Phenytoin or Levetiracetam due to an acute symptomatic seizure during acute hospitalisation 2. Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1349 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: MAST-PROPHYLAXIS: 1. Post-traumatic seizures 2. Un-survivable injury 3. Previous history of epilepsy 4. Patients who are taking an AED pre-TBI 5. Pregnancy or breastfeeding 6. Any known hypersensitivity to study drugs (or hydantoins or pyrrolidone derivatives) or any of their excipients 7. Time interval from the time of admission to NSU to randomisation exceeds 48 hours MAST DURATION 1. Un-survivable injury 2. Previous history of epilepsy 3. Patients who are on an AED pre-TBI 4. Patient who has been clinically prescribed an AED to treat PTS (other than phenytoin or levetiracetam) since current admission 5. Any hypersensitivity to study drug selected or any of its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: MAST_PROPHYLAXIS: To determine the comparative clinical effectiveness (absolute difference in the rate of PTS within the first 2 weeks post-TBI) of a 7-day course of phenytoin or levetiracetam, used as seizure prophylaxis, versus no AED for TBI patients MAST-DURATION: To determine the comparative clinical effectiveness (absolute difference in the rate of late PTS within 24 months post-TBI) of a longer course of AED (at least 6 months) versus a shorter course (up to 3 months) for TBI patients with early seizures. ;Secondary Objective: MAST-PROPHYLAXIS: 1. Compare the rate of PTS within 24 months post-TBI 2. Compare outcomes (extended Glasgow Outcome Scale), cognitive function (Neurobehavioural Symptom Inventory), quality of life (EQ-5D-5L), and adverse events (Liverpool Adverse Events Profile) at 6, 12, 18 and 24 months, between the three arms. 3. Undertake a detailed economic evaluation. 4. To compare the frequency of PTS between the three arms. 5. Mortality at 6, 12, 18 and 24 months. 6. Adverse events of special interest during treatment. MAST-DURATION: 1. Compare outcomes (extended Glasgow Outcome Scale), cognitive function (Neurobehavioural Symptom Inventory), quality of life (EQ-5D-5L), and adverse events (Liverpool Adverse Events Profile) at 6, 12, 18 and 24 months, between the two arms. 2. Undertake a detailed economic evaluation. 3. To compare the frequency of PTS between the two arms. 4. Mortality at 6, 12, 18 and 24 months. 5. Adverse events of special interest during treatment. ;Primary end point(s): MAST-PROPHYLAXIS: Occurrence of PTS within 2 weeks after TBI. MAST-DURATION: Occurrence of late PTS within 24 months after TBI. ;Timepoint(s) of evaluation of this end point: MAST-DURATION: Primary outcome - day 1, discharge, 6, 12, 18 and 24 months. MAST-PROPHYLAXIS: Primary outcome - day 7 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes (both trials: - questionnaires (functional outcomes, neurobehavioral symptoms, HRQOL) - Economic evaluation - Adverse events Secondary outcomes (MAST-PROPHYLAXIS ONLY): - occurrence/frequency of PTS within 24 months;Timepoint(s) of evaluation of this end point: Both trials: All questionnaires at 6, 12, 18 and 24 months. Economic evaluation at 24 months Adverse events during treatment only Secondary outcomes (MAST-PROPHYLAXIS ONLY): - occurrence/frequency of PTS at 6, 12, 18 and 24 months | — |
Countries
United Kingdom
Contacts
Public ContactRegulatory & Quality Manager
Cambridge Univeristy Hospitals NHS Foundation Trust
Outcome results
None listed