ClinicalTrials.gov
ClinicalTrials.gov Menu

Antiepileptic Drugs and Vascular Risk Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00774306
Recruitment Status : Terminated (study no longer consistent with current clinical practice)
First Posted : October 17, 2008
Results First Posted : November 25, 2014
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Subarachnoid Hemorrhage
Interventions Drug: phenytoin
Drug: valproate
Drug: levetiracetam
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phenytoin Valproate Levetiracetam No Anticonvulsant
Hide Arm/Group Description

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.

x

x

Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.

valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Participants randomized to Group 4 will receive no drug intervention.
Period Title: Overall Study
Started 24 5 16 7
Completed 6 3 8 2
Not Completed 18 2 8 5
Reason Not Completed
Adverse Event             3             0             0             0
Protocol Violation             2             0             3             0
Withdrawal by Subject             6             1             1             0
Lost to Follow-up             6             0             4             5
Death             1             1             0             0
Arm/Group Title Phenytoin Valproate Levetiracetam No Anticonvulsant Total
Hide Arm/Group Description

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.

valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Participants randomized to Group 4 will receive no drug intervention. Total of all reporting groups
Overall Number of Baseline Participants 24 5 16 7 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 5 participants 16 participants 7 participants 52 participants
48.5
(31 to 71)
46
(26 to 62)
51
(30 to 71)
49
(44 to 75)
48
(26 to 75)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 5 participants 16 participants 7 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  91.7%
5
 100.0%
14
  87.5%
5
  71.4%
46
  88.5%
>=65 years
2
   8.3%
0
   0.0%
2
  12.5%
2
  28.6%
6
  11.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 5 participants 16 participants 7 participants 52 participants
Female
14
  58.3%
4
  80.0%
10
  62.5%
6
  85.7%
34
  65.4%
Male
10
  41.7%
1
  20.0%
6
  37.5%
1
  14.3%
18
  34.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 5 participants 16 participants 7 participants 52 participants
24 5 16 7 52
1.Primary Outcome
Title Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms
Hide Description [Not Specified]
Time Frame 8 weeks, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phenytoin Valproate Levetiracetam No Anticonvulsant
Hide Arm/Group Description:

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.

x

x

Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.

valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Participants randomized to Group 4 will receive no drug intervention.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)
Hide Description [Not Specified]
Time Frame 8 weeks, 16 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phenytoin Valproate Levetiracetam No Anticonvulsant
Hide Arm/Group Description

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.

x

x

Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.

valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Participants randomized to Group 4 will receive no drug intervention.
All-Cause Mortality
Phenytoin Valproate Levetiracetam No Anticonvulsant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phenytoin Valproate Levetiracetam No Anticonvulsant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/24 (16.67%)   1/5 (20.00%)   4/16 (25.00%)   3/7 (42.86%) 
Immune system disorders         
drug fever  1/24 (4.17%)  0/5 (0.00%)  0/16 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
vasospasm  1/24 (4.17%)  1/5 (20.00%)  2/16 (12.50%)  1/7 (14.29%) 
hydrocephalus  1/24 (4.17%)  0/5 (0.00%)  1/16 (6.25%)  0/7 (0.00%) 
cerebral infarction  0/24 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders         
pulmonary edema  0/24 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/7 (14.29%) 
Vascular disorders         
deep venous thrombosis  1/24 (4.17%)  0/5 (0.00%)  1/16 (6.25%)  0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phenytoin Valproate Levetiracetam No Anticonvulsant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   1/5 (20.00%)   0/16 (0.00%)   0/7 (0.00%) 
Infections and infestations         
urinary tract infection  0/24 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/7 (0.00%) 

Study terminated due to 1) change in clinical practice; 2) inadequate recruitment and follow-up.

Number of pts providing full data was <15% of goal. Because of this, any analysis of data was considered futile, and no analyses were performed.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Scott Mintzer
Organization: Thomas Jefferson University
Phone: 215-955-1222
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00774306     History of Changes
Other Study ID Numbers: K23NS058669 ( U.S. NIH Grant/Contract )
1K23NS058669 ( U.S. NIH Grant/Contract )
First Submitted: October 16, 2008
First Posted: October 17, 2008
Results First Submitted: November 19, 2014
Results First Posted: November 25, 2014
Last Update Posted: December 18, 2017