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University of Alabama at Birmingham (UAB) Pediatric CBD Program

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ClinicalTrials.gov Identifier: NCT02695537
Recruitment Status : Completed
First Posted : March 1, 2016
Results First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Martina Bebin, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Seizures
Intervention Drug: Epidiolex
Enrollment 89
Recruitment Details Participants with treatment-resistant epilepsy in the state of Alabama were enrolled. Their primary treating neurologist provided the UAB CBD Treatment Approval Committee with the required information (found on www.uab.edu/cbd) to review. The committee either “approved/recommended” or “disapproved/not recommended” them for treatment in the study.
Pre-assignment Details Of the total 141 participants with epilepsy ages 1-19 screened, 89 were enrolled in this single-center, open-label study. This study was not randomized.
Arm/Group Title Epidiolex
Hide Arm/Group Description The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Period Title: Overall Study
Started 89
Completed 51
Not Completed 38
Reason Not Completed
Adverse Event             3
Lack of Efficacy             28
Withdrawal by Subject             4
Protocol Violation             3
Arm/Group Title Epidiolex
Hide Arm/Group Description The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
Baseline characteristics were reported for all participants who received Epidiolex at the starting dose of 5 mg/kg.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
9.7978  (4.9087)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
48
  53.9%
Male
41
  46.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Asian
3
   3.4%
Black or African American
14
  15.7%
White
72
  80.9%
1.Primary Outcome
Title Number of Participants With Severe Adverse Events (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).
Hide Description Severe adverse events (SAEs) were defined as increase in seizure frequency by more than 100% leading to emergency room visit or hospitalization. During study clinic and phone visits, adverse and severe adverse event monitoring and reporting were assessed among all participants. Data was recorded and stored in the UAB RedCap System.
Time Frame For 1 Year following Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, after all participants have been enrolled and followed for 1 year.
Arm/Group Title Epidiolex
Hide Arm/Group Description:
The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.
Hide Description During study clinic visits, participant vital signs, including blood pressure and heart rate, were collected. Data was recorded and stored in the UAB RedCap System. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events.
Time Frame For 1 Year following Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, after all participants have been enrolled and followed for 1 year.
Arm/Group Title Epidiolex
Hide Arm/Group Description:
The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
Blood Pressure
0
   0.0%
Heart Rate
0
   0.0%
3.Primary Outcome
Title Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.
Hide Description During study clinic visits, participants received laboratory testing to assess for side effects and toxicity. Data was recorded and stored in the UAB RedCap System. Laboratory testing included Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP; included Liver Function Tests (LFTs) mainly looking at alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), Urine Analysis (UA), and Antiepileptic Drug (AED) levels. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events.
Time Frame For 1 Year following Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, after all participants have been enrolled and followed for 1 year.
Arm/Group Title Epidiolex
Hide Arm/Group Description:
The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
CBC: White Blood Cell (WBC) Count
4
   4.5%
CBC: Red Blood Cell (RBC) Count
1
   1.1%
CBC: Hemoglobin
2
   2.2%
CBC: Hematocrit
2
   2.2%
CBC: Platelet
3
   3.4%
CBC: Absolute (ABS) Neutrophils
2
   2.2%
CBC: ABS Lymphocytes
1
   1.1%
CBC: ABS Monocytes
1
   1.1%
CBC: Neutrophils
1
   1.1%
CBC: Lymphocytes
0
   0.0%
CMP: Serum Creatinine
0
   0.0%
CMP: Creatinine Clearance
0
   0.0%
CMP: ALT (SGPT)
11
  12.4%
CMP: AST (SGOT)
8
   9.0%
CMP: Total Bilirubin
0
   0.0%
CMP: Direct Bilirubin
0
   0.0%
CMP: Blood Urea Nitrogen (BUN)
1
   1.1%
CMP: Albumin
0
   0.0%
CMP: Alkaline Phosphate
1
   1.1%
CMP: Glucose
0
   0.0%
CMP: Calcium
0
   0.0%
CMP: Carbon Dioxide
0
   0.0%
CMP: Chloride
0
   0.0%
CMP: Potassium
1
   1.1%
CMP: Sodium
2
   2.2%
UA: Specific Gravity
0
   0.0%
UA: PH
0
   0.0%
UA: Leukocyte Esterase
27
  30.3%
UA: Nitrite
3
   3.4%
UA: Protein
21
  23.6%
UA: Glucose
5
   5.6%
UA: Ketones
27
  30.3%
UA: Urubilinogen
21
  23.6%
UA: Bilirubin
4
   4.5%
UA: Blood
18
  20.2%
AED: Phenobarbital Level
1
   1.1%
AED: Primidone Level
0
   0.0%
AED: Klonopin Level
0
   0.0%
AED: Clobazam Level
0
   0.0%
AED: Desmethylclobazam Level
0
   0.0%
AED: Lorazepam Level
0
   0.0%
AED: Phenytoin Level
0
   0.0%
AED: Carbamazepine Level
0
   0.0%
AED: Clorazepate Level
0
   0.0%
AED: Valproate Level
0
   0.0%
AED: Felbamate Level
1
   1.1%
AED: Gabapentin Level
0
   0.0%
AED: Lamotrigine Level
0
   0.0%
AED: Levetiracetam Level
0
   0.0%
AED: Oxcarbazepine Level
0
   0.0%
AED: Ethosuximide Level
1
   1.1%
AED: Tiagabine Level
0
   0.0%
AED: Topiramate Level
0
   0.0%
AED: Vigabatrin Level
0
   0.0%
AED: Zonisamide Level
0
   0.0%
AED: Eslicarbazepine Level
0
   0.0%
AED: Ezogabine Level
0
   0.0%
AED: Pregabalin Level
0
   0.0%
AED: Perampanel Level
0
   0.0%
AED: Rufinamide Level
0
   0.0%
AED: Brivaracetam Level
0
   0.0%
AED: Lacosamide Level
0
   0.0%
AED: Diazepam Level
0
   0.0%
4.Secondary Outcome
Title Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.
Hide Description Participants were given seizure diary logs and dairy data collection was done at study clinic visits. Data was recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure frequency over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the frequency of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics.
Time Frame For 1 Year following Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, after all participants have been enrolled and followed for 1 year. Number of participants analyzed differed because: 1) Those who responded to a certain CBD dose had fewer monthly visits; 2) Those who decided to continue on the same CBD dose had fewer monthly visits; or 3) Withdrawal prior to 1 year following enrollment.
Arm/Group Title Epidiolex
Hide Arm/Group Description:
The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Participants Analyzed 89
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: number of seizures/month
Month 1 vs Baseline Number Analyzed 89 participants
0.63
(0.56 to 0.72)
Month 2 vs Baseline Number Analyzed 86 participants
0.44
(0.36 to 0.55)
Month 3 vs Baseline Number Analyzed 82 participants
0.38
(0.3 to 0.5)
Month 4 vs Baseline Number Analyzed 76 participants
0.38
(0.29 to 0.51)
Month 5 vs Baseline Number Analyzed 68 participants
0.4
(0.29 to 0.56)
Month 6 vs Baseline Number Analyzed 65 participants
0.41
(0.29 to 0.6)
Month 7 vs Baseline Number Analyzed 43 participants
0.42
(0.28 to 0.62)
Month 8 vs Baseline Number Analyzed 38 participants
0.41
(0.28 to 0.62)
Month 9 vs Baseline Number Analyzed 43 participants
0.41
(0.27 to 0.62)
Month 10 vs Baseline Number Analyzed 30 participants
0.39
(0.25 to 0.61)
Month 11 vs Baseline Number Analyzed 28 participants
0.38
(0.23 to 0.62)
Month 12 vs Baseline Number Analyzed 40 participants
0.36
(0.21 to 0.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epidiolex
Comments Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.
Type of Statistical Test Other
Comments Single group.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value reported above is the global test for change in seizure frequency over a 12-month period.
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.
Other Statistical Analysis Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
5.Secondary Outcome
Title Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).
Hide Description Seizure severity was collected during study clinic and phone visits using the Chalfont Seizure Severity Scale (CSSS) (Duncan & Sander, 1991, JNNP) through verbal reporting. The CSSS measured components of seizures most disturbing or disruptive to the participants. The total scores for a given seizure type was its severity score. High scores indicated high severity of the seizures (no fixed maximum value), while a score of zero indicated low severity. Scores were recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure severity scores over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the severity of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics.
Time Frame For 1 Year following Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, after all participants have been enrolled and followed for 1 year. Number of participants analyzed differed because: 1) Those who responded to a certain CBD dose had fewer monthly visits; 2) Those who decided to continue on the same CBD dose had fewer monthly visits; or 3) Withdrawal prior to 1 year following enrollment.
Arm/Group Title Epidiolex
Hide Arm/Group Description:
The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
Overall Number of Participants Analyzed 89
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
Month 1 vs Baseline Number Analyzed 89 participants
0.66
(0.58 to 0.75)
Month 2 vs Baseline Number Analyzed 86 participants
0.47
(0.37 to 0.59)
Month 3 vs Baseline Number Analyzed 82 participants
0.37
(0.28 to 0.5)
Month 4 vs Baseline Number Analyzed 76 participants
0.35
(0.26 to 0.46)
Month 5 vs Baseline Number Analyzed 68 participants
0.36
(0.28 to 0.48)
Month 6 vs Baseline Number Analyzed 65 participants
0.4
(0.3 to 0.52)
Month 7 vs Baseline Number Analyzed 43 participants
0.43
(0.33 to 0.55)
Month 8 vs Baseline Number Analyzed 38 participants
0.44
(0.34 to 0.58)
Month 9 vs Baseline Number Analyzed 43 participants
0.45
(0.35 to 0.59)
Month 10 vs Baseline Number Analyzed 30 participants
0.46
(0.35 to 0.6)
Month 11 vs Baseline Number Analyzed 28 participants
0.46
(0.34 to 0.63)
Month 12 vs Baseline Number Analyzed 40 participants
0.46
(0.31 to 0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epidiolex
Comments Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.
Type of Statistical Test Other
Comments Single group.
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value reported above is the global test for change in seizure severity scores over a 12-month period.
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.
Other Statistical Analysis Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
Time Frame For 1 Year following Enrollment
Adverse Event Reporting Description Adverse events and severe adverse events were collected and reported in all enrolled participants who received study drug. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03 was used to determine clinical significance. Adverse events categorized as a grade 3 or above was considered clinically significant. Adverse events grade 4 or above was considered severe adverse events.
 
Arm/Group Title Epidiolex
Hide Arm/Group Description The participants (or their caregivers) self-administered CBD 100mg/mL oral solution at a starting dose of 5 mg/kg/day in twice daily dosing and titrated by 5 mg/kg/2 weeks up to 25 mg/kg/day. Additional increases in dosing, by 5 mg/kg/day up to a maximum of 50 mg/kg/day, was instituted at the discretion of the treating PI.
All-Cause Mortality
Epidiolex
Affected / at Risk (%)
Total   0/89 (0.00%)    
Hide Serious Adverse Events
Epidiolex
Affected / at Risk (%) # Events
Total   15/89 (16.85%)    
Blood and lymphatic system disorders   
Abnormal liver funtion panel * [1]  1/89 (1.12%)  2
Gastrointestinal disorders   
Fecal impaction *  1/89 (1.12%)  1
General disorders   
Hospital admission *  6/89 (6.74%)  8
Hepatobiliary disorders   
Nausea *  1/89 (1.12%)  1
Metabolism and nutrition disorders   
Dehydration *  1/89 (1.12%)  1
Nervous system disorders   
Dysphagia *  1/89 (1.12%)  2
Increased seizure frequency *  3/89 (3.37%)  3
Renal and urinary disorders   
Urinary tract infection *  1/89 (1.12%)  2
Respiratory, thoracic and mediastinal disorders   
Aspiration pneumonia *  1/89 (1.12%)  2
Pneumonia *  1/89 (1.12%)  2
Obstructive sleep apnea *  1/89 (1.12%)  1
Skin and subcutaneous tissue disorders   
Rash *  1/89 (1.12%)  2
Surgical and medical procedures   
Spinal fusion for scoliosis *  1/89 (1.12%)  1
Gastrostomy tube (G-tube) placement *  1/89 (1.12%)  1
Elective endoscopy *  1/89 (1.12%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Elevated ALT, Elevated AST
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epidiolex
Affected / at Risk (%) # Events
Total   82/89 (92.13%)    
Blood and lymphatic system disorders   
Abnormal CBC values *  4/89 (4.49%)  28
Abnormal liver function panel *  8/89 (8.99%)  37
Anemia *  1/89 (1.12%)  9
Thrombocytopenia *  2/89 (2.25%)  3
Hyponatremia *  2/89 (2.25%)  8
Hypokalemia *  1/89 (1.12%)  1
Leukopenia *  1/89 (1.12%)  6
Ear and labyrinth disorders   
Otitis media *  5/89 (5.62%)  6
Eye disorders   
Sty *  1/89 (1.12%)  11
Conjunctivitis *  1/89 (1.12%)  4
Gastrointestinal disorders   
Diarrhea *  31/89 (34.83%)  156
Constipation *  5/89 (5.62%)  26
Loose stool *  1/89 (1.12%)  66
Gastroesophageal reflux disease (GERD) *  2/89 (2.25%)  19
General disorders   
Hospital admission *  1/89 (1.12%)  1
Weight gain *  2/89 (2.25%)  10
Hair loss *  1/89 (1.12%)  3
Concussion *  1/89 (1.12%)  1
Hepatobiliary disorders   
Anorexia *  2/89 (2.25%)  14
Increased appetite *  1/89 (1.12%)  12
Decreased appetite *  4/89 (4.49%)  42
Malnutrition *  1/89 (1.12%)  6
Distended gallbladder *  1/89 (1.12%)  7
Abdominal pain *  6/89 (6.74%)  28
Nausea *  11/89 (12.36%)  33
Infections and infestations   
Flu *  4/89 (4.49%)  5
Viral gastroenteritis *  4/89 (4.49%)  5
Tonsilitis *  1/89 (1.12%)  1
Common cold *  7/89 (7.87%)  11
Ear infection *  7/89 (7.87%)  16
Tooth abscess *  1/89 (1.12%)  1
Fever *  5/89 (5.62%)  7
Upper respiratory tract infection *  6/89 (6.74%)  12
Strep pharyngitis *  1/89 (1.12%)  1
Strep throat *  6/89 (6.74%)  7
Sinusitis *  6/89 (6.74%)  8
Injury, poisoning and procedural complications   
Fracture (seizure-related) *  1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders   
Upper body pain * [1]  2/89 (2.25%)  6
Nervous system disorders   
Sedation *  39/89 (43.82%)  260
Insomnia *  10/89 (11.24%)  61
Dizziness *  6/89 (6.74%)  20
Sleep disturbance *  2/89 (2.25%)  20
Ataxia *  4/89 (4.49%)  17
Double vision *  1/89 (1.12%)  3
Lethargic *  2/89 (2.25%)  13
Dysphagia *  1/89 (1.12%)  2
Loss of motor control *  1/89 (1.12%)  8
Memory loss *  1/89 (1.12%)  1
Psychiatric disorders   
Depression/mood issues *  13/89 (14.61%)  104
Behavior changes *  7/89 (7.87%)  48
Homicidal thoughts *  1/89 (1.12%)  2
Renal and urinary disorders   
Urinary retention *  1/89 (1.12%)  1
Urinary tract infection *  2/89 (2.25%)  4
Proteinuria *  1/89 (1.12%)  2
Reproductive system and breast disorders   
Menorrhagia *  4/89 (4.49%)  5
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/89 (1.12%)  1
Croup *  1/89 (1.12%)  1
Hypoxemia *  1/89 (1.12%)  1
Nasal congestion *  1/89 (1.12%)  1
Seasonal allergies *  1/89 (1.12%)  1
Nosebleeds *  2/89 (2.25%)  16
Pharyngitis *  1/89 (1.12%)  1
Skin and subcutaneous tissue disorders   
Rash *  5/89 (5.62%)  9
Hematoma *  1/89 (1.12%)  2
Acne *  1/89 (1.12%)  1
Eczema *  1/89 (1.12%)  17
Cellulitis *  1/89 (1.12%)  1
Ecchymosis *  2/89 (2.25%)  3
Ingrown toenail *  1/89 (1.12%)  1
Lacerations * [2]  3/89 (3.37%)  3
Diaper rash *  1/89 (1.12%)  1
Surgical and medical procedures   
Ear tube placement *  1/89 (1.12%)  1
Port placement *  1/89 (1.12%)  1
Wisdom teeth extraction *  1/89 (1.12%)  1
Vascular disorders   
Headaches *  4/89 (4.49%)  5
*
Indicates events were collected by non-systematic assessment
[1]
Includes chest, arm, hand
[2]
Laceration on lip
Flexible dosing schedule; Over- or underreporting of seizure frequency and severity that may reflect patients' or caregivers' desires to qualify or remain in the study; Non-normality of the data; Early withdrawal of participants.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Martina Bebin, MD
Organization: University of Alabama at Birmingham
Phone: 205-934-3866
EMail: ebebin@uab.edu
Publications:
Pinheiro, J.C. and Bates, D.M. (2000). Mixed-Effects Models in S and S-Plus. Springer, Verlag, New York
Layout table for additonal information
Responsible Party: Martina Bebin, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02695537    
Other Study ID Numbers: IRB-140905010
First Submitted: February 24, 2016
First Posted: March 1, 2016
Results First Submitted: February 27, 2020
Results First Posted: April 10, 2020
Last Update Posted: April 10, 2020