Comparing anti-epileptic treatments for seizures following traumatic brain injury

Phase 3

• Conditions: Post-traumatic seizures in traumatic brain injury patients; Nervous System Diseases

• Registration Number: ISRCTN13200656
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 22 March 2021
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1649

Inclusion Criteria

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

MAST-PROPHYLAXIS:
1. Patients aged =10 years, with TBI managed in an NSU without an acute symptomatic 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 enrolment

Exclusion Criteria

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

MAST-PROPHYLAXIS:
1. Post-traumatic seizures
2. Unsurvivable injury
3. Previous history of epilepsy
4. Patients who are on an AED pre-TBI
5. Pregnancy or breastfeeding
6. Any hypersensitivity to study drug (or hydantoins or pyrrolidone derivatives) or any of its excipients
7. Time interval from the time of admission to NSU to randomisation exceeds 48 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> MAST-DURATION: Occurrence of late PTS measured using self-report questionnaire within 24 months after TBI<br> MAST-PROPHYLAXIS: Occurrence of PTS measured using clinical observation/self-report questionnaire within 2 weeks after TBI<br>