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Trial record 13 of 146 for:    epilepsy AND Bethesda

PRX-00023 Therapy in Localization-Related 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: NCT01281956
Recruitment Status : Terminated
First Posted : January 24, 2011
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Epilepsy
Epilepsy, Temporal Lobe
Partial Epilepsy
Interventions Drug: PRX-00023
Drug: Placebo
Enrollment 12
Recruitment Details  
Pre-assignment Details Two participants that were consented to the protocol, did not participate in the study procedures. One participant was screened but was not randomized and did not receive study drug or placebo and one participant did not return for screening visit.
Arm/Group Title Placebo Then PRX PRX Then Placebo
Hide Arm/Group Description Participants with epilepsy receiving placebo during the first period followed by PRX during the second period Participants with epilepsy receiving PRX during the first period followed by Placebo during the second period
Period Title: 1st Intervention (3 Months)
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: 2nd Intervention (3 Months)
Started 5 5
Completed 4 5
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title All Participants Enrolled in Study
Hide Arm/Group Description All participants enrolled in the study
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
40  (12.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Seizure Frequency in the Active and Placebo Periods
Hide Description Participants used a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. Seizure frequency was calculated as the total number of seizures occurring during each three month period. For each period a mean was calculated across subjects.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving Placebo
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: number of seizures
66.6  (93.3) 54.3  (79.7)
2.Secondary Outcome
Title Number of Participants With > 50% Lower Seizure Rate on PRX-0023.
Hide Description Participants used a seizure calendar to record the number of seizures that occurred during each three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. Seizure rate was calculated as the total number of seizures occurring during the three month period. The number of participants with >50% lower seizure frequency during the active compared with the placebo period was determined.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants Who Completed Study
Hide Arm/Group Description:
All participants who completed both arms of the study
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Mean Score on the Hamilton Anxiety Rating Scale at the End of the Active and Placebo Periods.
Hide Description Participants were administered the Hamilton Anxiety Rating Scale (HAM-A) at the end of each three month treatment period, i.e., while participants were either on PRX-0023 or Placebo. The HAM-A measures an individual’s severity of anxiety symptoms. The scale consists of 14 parameters, each defined by a series of symptoms. Each group of symptoms is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where </=17 indicates mild anxiety, 18–24 mild to moderate anxiety and 25–30 moderate to severe anxiety and >30 severe anxiety.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving Placebo
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.1  (5.0) 5.7  (5.7)
4.Secondary Outcome
Title Mean Score on the Hamilton Depression Rating Scale at the End of the Active and Placebo Periods
Hide Description The Hamilton Depression Rating Scale (HAM-D) was administered to participants at the end of each treatment period. The HAM-D is a multiple item questionnaire used to provide an indication of depression. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Although the HAM-D form lists 21 items, the scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2 with 0 = absent and 2 = frequent or severe. Scores range from 0 to 50 with a score of 0-7 representing normal and a score >/= 23 representing very severe depression.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.3  (3.9) 8.6  (12.8)
5.Secondary Outcome
Title Mean Score on the Hopkins Verbal Learning Test-Revised (HVLT-R) at the End of the Active and Placebo Periods
Hide Description The HVLT-R is a word-list learning and memory test.The participant is read a list of words and asked to recall as many as possible, without regard to the order in which they were read.The list is read three times with recall requested after each presentation (immediate recall) and after a delay (delayed recall). Individual test results are compared to others of the same age (+/-5 years).Test results are presented as T-scores which are conventionally used in neuropsychology. The participant’s raw scores are compared to a population expected raw score, for a particular age group. That score is converted to a T-score.The interpretation of these T-scores is such that 50 is representative of the normal score in that age group in the general population. The standard deviation of these distributions are 10 units. Therefore, a score between 30-40 is considered mildly impaired, 20-30 is indicative of severe problems with learning and memory and a score of 60-70 indicates a very good memory.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete the delayed recall in one participant in the placebo arm.
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: psychometric T-score
Immediate Recall Number Analyzed 9 participants 10 participants
34.8  (13.8) 41.6  (10.1)
Delayed Recall Number Analyzed 9 participants 9 participants
33.3  (14.1) 39.2  (10.8)
6.Secondary Outcome
Title The Mean Score on the Brief Visuospatial Memory Test-Revised (BVMT-R), at the End of the Active and Placebo Period.
Hide Description The BVMT-R is a test of memory for visual information. Participants are shown a page with several geometric designs arranged in a 2x3 matrix and asked to study the designs. After the page is shown for a brief period the participant is asked to draw each figure.The same page is shown three times with recall requested after each presentation (immediate recall) and after a delay (delayed recall). Individual test results are compared to other people the same age (+/- 5 years).Test results are presented as T-scores which are conventionally used in neuropsychology. The participant’s raw scores are compared to a population expected raw score, for a particular age group.That score is converted to a T-score.The interpretation of these T-scores is such that 50 is representative of the normal score in that age group in the general population.The standard deviation of these distributions are 10 units. A score of 30-40 is considered mildly impaired, 20-30 is indicative of severe problems
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to complete the delayed recall in one subject in the placebo arm
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: psychometric T-score
Immediate Recall Number Analyzed 9 participants 10 participants
37.4  (9.7) 39.0  (9.9)
Delayed Recall Number Analyzed 9 participants 9 participants
38.0  (11.9) 37.4  (15.4)
7.Secondary Outcome
Title Mean Score on the Columbia Suicide Severity Rating Scale at the End of the Active and Placebo Periods
Hide Description The Columbia Suicide Severity Rating Scale (C-SSRS) was administered to subjects at the end of each treatment period. The C-SSRS, is a suicidal ideation and behavior rating scale which evaluates suicide risk. The assessment rates an individual's degree of suicidal ideation on a scale, ranging from 0 to 6 as follows: 0 = No suicide ideation; 1 = Wish to be dead; 2 = Non-Specific Active Suicidal Thoughts; 3 = Active Suicidal Ideation with any methods (No Plan) without intent to act; 4 = Active Suicidal Ideation with some intent to act, without specific plan; 5 = Active Suicidal Ideation with specific plan and intent; and 6 = Actual Suicide Attempt
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data for one participant in the Placebo group
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
9
 100.0%
8
  88.9%
1
0
   0.0%
1
  11.1%
2
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
5
0
   0.0%
0
   0.0%
6
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Results of Clinical Examination of the Nervous System at the End of the Active and Placebo Treatment Periods
Hide Description A clinical examination of the nervous system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
8
  88.9%
9
  90.0%
1
0
   0.0%
0
   0.0%
2
1
  11.1%
1
  10.0%
3
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Results of Clinical Examination of the Respiratory System at the End of the Active and Placebo Treatment Periods
Hide Description A clinical examination of the respiratory system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
8
  88.9%
10
 100.0%
1
1
  11.1%
0
   0.0%
2
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Results of Clinical Examination of the Cardiovascular System at the End of the Active and Placebo Treatment Periods
Hide Description A clinical examination of the cardiovascular system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
8
  88.9%
9
  90.0%
1
1
  11.1%
1
  10.0%
2
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Results of Clinical Examination of the Musculoskeletal System at the End of the Active and Placebo Treatment Periods
Hide Description A clinical examination of the musculoskeletal system was administered by a physician to subjects at the end of each three month treatment period, i.e., while the participant was on PRX-0023 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0 = normal examination; 1 = Observation only; patient asymptomatic; 2 = Patient reports complaint associated with finding but no dysfunction; 3 = Patient reports some impairment of daily function associated with finding; 4 = Patient unable to carry out usual activities due to dysfunction associated with finding.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
9
 100.0%
9
  90.0%
1
0
   0.0%
1
  10.0%
2
0
   0.0%
0
   0.0%
3
0
   0.0%
0
   0.0%
4
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Subjects With an Abnormal CBC Result at the End of the Active and Placebo Periods
Hide Description A Complete Blood Count (CBC) was administered at the end of each three month treatment period. A complete blood count test measures several components and features of your blood, including: Red blood cells (which carry oxygen), White blood cells (which fight infection), Hemoglobin (the oxygen-carrying protein in red blood cells), Hematocrit (the proportion of red blood cells to the fluid component (plasma) in your blood), Platelets, (which help with blood clotting). Abnormal increases or decreases in cell counts as revealed in a complete blood count may indicate an underlying medical condition, i.e., anemia (abnormal red blood cells, hemoglobin, and/or hematocrit), leucopenia (a decrease in white blood cells), leucocytosis (an increase in white blood cells), and thrombocytosis (an increase in platelets). Results were classified as either normal or abnormal.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
anemia
2
  22.2%
1
  10.0%
leucopenia
2
  22.2%
1
  10.0%
leucocytosis
2
  22.2%
3
  30.0%
thrombocytosis
0
   0.0%
2
  20.0%
13.Secondary Outcome
Title Number of Subjects With Abnormal Clinical Chemistry Labs at the End of the Active and Placebo Periods
Hide Description The number of subjects with abnormal clinical chemistry labs which is defined as a value outside of the NIH Clinical Center normal range.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX-0023
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
electrolyte abnormality
4
  44.4%
4
  40.0%
hyperglycemia
2
  22.2%
1
  10.0%
elevated liver function < 2 x normal
3
  33.3%
3
  30.0%
elevated liver function > 2 x normal
1
  11.1%
0
   0.0%
abnormal urinalysis
3
  33.3%
4
  40.0%
elevated uric acid
0
   0.0%
1
  10.0%
elevated BUN or Creatinine
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Subjects With an Abnormal ECG Result at the End of the Active and Placebo Periods
Hide Description An electrocardiogram was administered to participants at the end of each treatment period, i.e., at the end of the PRX-0023 and Placebo treatment periods. The number of abnormal ECG readings was noted in this measure.
Time Frame Three months
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description:
Participants with epilepsy receiving PRX
Participants with epilepsy receiving placebo
Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
3
  33.3%
Time Frame Adverse Events were collected following baseline history and physical examination and continued until study completion. Study duration was 42-46 weeks (+/- 4 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRX-0023 Placebo
Hide Arm/Group Description Participants with epilepsy receiving PRX-0023 Participants with epilepsy receiving placebo
All-Cause Mortality
PRX-0023 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PRX-0023 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PRX-0023 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      7/10 (70.00%)    
Eye disorders     
Eye pain *  1/9 (11.11%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Constipation *  1/9 (11.11%)  1 1/10 (10.00%)  1
Diarrhea *  1/9 (11.11%)  2 0/10 (0.00%)  0
GI Upset *  1/9 (11.11%)  2 1/10 (10.00%)  1
Weight gain *  0/9 (0.00%)  0 1/10 (10.00%)  1
Increased appetite *  0/9 (0.00%)  0 1/10 (10.00%)  2
Hepatobiliary disorders     
Elevated liver function test >2x normal *  1/9 (11.11%)  1 0/10 (0.00%)  0
Infections and infestations     
Upper Respiratory Infection * [1]  2/9 (22.22%)  2 1/10 (10.00%)  1
Stomach flu *  1/9 (11.11%)  1 0/10 (0.00%)  0
Achy and sweaty *  0/9 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Injury following seizure *  1/9 (11.11%)  1 0/10 (0.00%)  0
Nervous system disorders     
Gait Imbalance *  1/9 (11.11%)  1 0/10 (0.00%)  0
Headache *  0/9 (0.00%)  0 2/10 (20.00%)  2
Lethargy *  0/9 (0.00%)  0 4/10 (40.00%)  4
Respiratory, thoracic and mediastinal disorders     
Chest pressure during sleep *  0/9 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Itching *  1/9 (11.11%)  1 2/10 (20.00%)  2
Small bumps on back *  1/9 (11.11%)  3 0/10 (0.00%)  0
Bumps at IV site *  1/9 (11.11%)  1 0/10 (0.00%)  0
Change in nails and hair *  1/9 (11.11%)  1 0/10 (0.00%)  0
Bug bites *  0/9 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Chest cold, URI
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William Theodore
Organization: National Institutes of Health
Phone: 301-496-1505
EMail: theodorw@ninds.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01281956     History of Changes
Other Study ID Numbers: 110039
11-N-0039
First Submitted: January 21, 2011
First Posted: January 24, 2011
Results First Submitted: October 10, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018