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Trial record 42 of 103 for:    PHENYTOIN

Antiepileptic Drugs and Vascular Risk Markers

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phenytoin

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

Valproate

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.

Levetiracetam

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.

No Anticonvulsant Participants randomized to Group 4 will receive no drug intervention.

Participant Flow:   Overall Study
    Phenytoin   Valproate   Levetiracetam   No Anticonvulsant
STARTED   24   5   16   7 
COMPLETED   6   3   8   2 
NOT COMPLETED   18   2   8   5 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phenytoin

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.

Valproate

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.

Levetiracetam

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.

No Anticonvulsant Participants randomized to Group 4 will receive no drug intervention.
Total Total of all reporting groups

Baseline Measures
   Phenytoin   Valproate   Levetiracetam   No Anticonvulsant   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   5   16   7   52 
Age 
[Units: Years]
Median (Full Range)
 48.5 
 (31 to 71) 
 46 
 (26 to 62) 
 51 
 (30 to 71) 
 49 
 (44 to 75) 
 48 
 (26 to 75) 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   24   5   16   7   52 


  Outcome Measures

1.  Primary:   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   [ Time Frame: 8 weeks, 16 weeks ]

2.  Secondary:   Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)   [ Time Frame: 8 weeks, 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information

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
e-mail: scott.mintzer@jefferson.edu



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