Trial Outcomes & Findings for Levetiracetam to Prevent Post-Traumatic Epilepsy (NCT NCT01463033)

NCT ID: NCT01463033

Last Updated: 2016-01-13

Results Overview

occurrence of PTE (Post-Traumatic Epilepsy)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Levetiracetam 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Observational 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Overall Study STARTED	66	60
Overall Study COMPLETED	59	54
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Levetiracetam 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Observational 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Overall Study Lost to Follow-up	4	4
Overall Study Death	3	2

Baseline Characteristics

Levetiracetam to Prevent Post-Traumatic Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam n=66 Participants 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Observational n=60 Participants 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	33 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	49 Participants n=7 Participants	99 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

occurrence of PTE (Post-Traumatic Epilepsy)

Outcome measures

Outcome measures
Measure	Levetiracetam n=66 Participants 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Observational n=60 Participants 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Post-Traumatic Epilepsy	6 participants	8 participants

SECONDARY outcome

Timeframe: 30 day treatment period

Population: The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.

The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.

Outcome measures

Outcome measures
Measure	Levetiracetam n=66 Participants 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.	Observational 60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Adverse Events Headache	28 Events	—
Adverse Events Fatigue	28 Events	—
Adverse Events Drowsiness	20 Events	—
Adverse Events Memory Impairment	9 Events	—
Adverse Events Amnesia	8 Events	—
Adverse Events Pain	15 Events	—
Adverse Events Irritability	10 Events	—
Adverse Events Dizziness	10 Events	—
Adverse Events Anorexia	6 Events	—
Adverse Events Emotional lability	7 Events	—
Adverse Events Insomnia	5 Events	—
Adverse Events Cognitive changes	7 Events	—
Adverse Events Ataxia	6 Events	—
Adverse Events Depression	7 Events	—
Adverse Events Hostility	3 Events	—
Adverse Events Vertigo	1 Events	—
Adverse Events Nausea	2 Events	—
Adverse Events Cough	2 Events	—
Adverse Events Nervousness	5 Events	—
Adverse Events Paraesthesia	3 Events	—
Adverse Events Weight gain	1 Events	—
Adverse Events Hallucinations	5 Events	—
Adverse Events Other	2 Events	—
Adverse Events Diplopia	3 Events	—
Adverse Events Suicidality	3 Events	—
Adverse Events Psychosis	3 Events	—

Adverse Events

Levetiracetam

Serious events: 18 serious events

Other events: 66 other events

Deaths: 0 deaths

Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Levetiracetam n=66 participants at risk The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	Observational Adverse events were not monitored for the Observational group
Psychiatric disorders Depression	10.6% 7/66 • Number of events 7 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Psychiatric disorders Halluscinations	7.6% 5/66 • Number of events 5 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Psychiatric disorders Suicidality	4.5% 3/66 • Number of events 3 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Psychiatric disorders Psychosis	4.5% 3/66 • Number of events 3 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.

Other adverse events

Additional Information

Dr. Pavel Klein, P.I.

Children's National Medical Center

Phone: 301-704-4925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Levetiracetam n=66 participants at risk The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	Observational Adverse events were not monitored for the Observational group
Nervous system disorders Headache	42.4% 28/66 • Number of events 28 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
General disorders Fatigue	42.4% 28/66 • Number of events 28 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Drowsiness	30.3% 20/66 • Number of events 20 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Memory Impairment	13.6% 9/66 • Number of events 9 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Amnesia	12.1% 8/66 • Number of events 8 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
General disorders Pain	22.7% 15/66 • Number of events 15 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
General disorders Irritability	15.2% 10/66 • Number of events 10 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Dizziness	15.2% 10/66 • Number of events 10 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Metabolism and nutrition disorders Anorexia	9.1% 6/66 • Number of events 6 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Psychiatric disorders Insomnia	7.6% 5/66 • Number of events 5 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Cognitive disturbance	10.6% 7/66 • Number of events 7 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Nervous system disorders Ataxia	9.1% 6/66 • Number of events 6 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Ear and labyrinth disorders Vertigo	1.5% 1/66 • Number of events 1 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Gastrointestinal disorders Nausea	3.0% 2/66 • Number of events 2 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 2/66 • Number of events 2 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Investigations Weight Gain	1.5% 1/66 • Number of events 1 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.	— 0/0 • 30 day treatment period The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.