Management of seizures following traumatic brain injury

Phase 1

• Conditions: Post traumatic seizures following traumatic brain injury; MedDRA version: 20.0Level: HLGTClassification code 10039911Term: Seizures (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000282-16-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-14
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified