Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 107 for:    PHENYTOIN

Evaluating the Transporter Protein Inhibitor Probenecid In Patients With Epilepsy

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: NCT00610532
Recruitment Status : Terminated (Investigators decided not to continue)
First Posted : February 8, 2008
Results First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Jim McAuley, Ohio State University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: phenytoin
Drug: phenytoin and probenecid
Enrollment 8
Recruitment Details Patients were recruited between Feb 2006 and Sept 2007.
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
Period Title: Intravenous Phenytoin Alone
Started 8
Completed 8
Not Completed 0
Period Title: Intravenous Phenytoin Plus Probenecid
Started 7 [1]
Completed 7
Not Completed 0
[1]
one participant dropped out between periods
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
33  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
0
   0.0%
Male
8
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Quantitative EEG Recordings
Hide Description [Not Specified]
Time Frame end of each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data was analyzed because the study was terminated by the investigators after they decided not to continue the project
Arm/Group Title Intravenous Phenytoin Alone Intravenous Phenytoin Plus Probenecid
Hide Arm/Group Description:
intravenous phenytoin alone
intravenous phenytoin plus probenecid
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Phenytoin Alone Intravenous Phenytoin Plus Probenecid
Hide Arm/Group Description intravenous phenytoin alone intravenous phenytoin plus probenecid
All-Cause Mortality
Intravenous Phenytoin Alone Intravenous Phenytoin Plus Probenecid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Phenytoin Alone Intravenous Phenytoin Plus Probenecid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   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 0%
Intravenous Phenytoin Alone Intravenous Phenytoin Plus Probenecid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
problems with measurement led to uninterpretable data
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jim McAuley
Organization: The Ohio State University
Phone: 614-292-9713
Responsible Party: Jim McAuley, Ohio State University
ClinicalTrials.gov Identifier: NCT00610532     History of Changes
Other Study ID Numbers: 2005H0170
First Submitted: January 28, 2008
First Posted: February 8, 2008
Results First Submitted: December 6, 2012
Results First Posted: May 14, 2013
Last Update Posted: May 14, 2013