CDKL5 Deficiency Disorder
Conditions
Keywords
refractory seizures, genetic pediatric encephalopathies, epilepsy in children, seizure disorder
Brief summary
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
Detailed description
The Marigold Study is a global, double-blind, placebo-controlled, Phase 3 clinical trial that will enroll approximately 70 patients between the ages of 2 and 21 with a confirmed disease-related CDKL5 gene variant. Patients will undergo a baseline period before being randomized to receive, in addition to their existing anti-seizure treatment, either ganaxolone or placebo for 17 weeks. Following the treatment period, all patients that meet certain eligibility requirements will have the opportunity to receive ganaxolone in the open label phase of the study. The study's primary efficacy endpoint is percent reduction in seizures. Secondary outcome measures will include non-seizure-related endpoints to capture certain behavioral and sleep disturbances that have been seen in previous clinical studies with ganaxolone.
Interventions
DRUGganaxolone
active drug
DRUGPlacebo
inactive
Sponsors
Marinus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Genetically confirmed CDKL5 gene mutation, seizure onset by 1 year of age and lack of independent ambulation by 2 years of age * Failure to control seizures despite 2 or more anti-seizure medications * At least 16 seizures per 28 days of primary seizure types * On a stable regimen of 0-4 anti-seizure medications (Vagus nerve stimulator, ketogenic diet, and modified Atkins diet do not count towards this limit) * Additional Inclusion Criteria apply and can be discussed with study team
Exclusion criteria
* Previous exposure to ganaxolone * West Syndrome with hypsarrhythmia pattern on EEG or seizures predominantly of Infantile Spasms type * Use of adrenocorticotropic hormone (ACTH), prednisone or other glucocorticoid or use of moderate or strong inducers or inhibitors of CYP3A4/5/7 are prohibited * Use of tetrahydrocannabinol (THC) or cannabidiol (CBD) is prohibited during the double-blind phase, unless patient has a prescription of Epidiolex® * Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening * Plasma allopregnanolone-sulfate (Allo-S) levels greater than or equal to 6.0 ng/ml at screening visit * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of 28-day Seizure Frequency for Major Motor Seizure Types | End of the double-blind 17 week treatment period | Summary of 28-day seizure frequency for Major Motor Seizure Types during the double-blind treatment period relative to the 6-week prospective baseline period Note: Summaries are based on the sum of the individual seizures, the countable seizures, and the clusters with uncountable seizures (each cluster with uncountable seizures counts as 1 seizure). Within the baseline and post baseline intervals, 28-day seizure frequency was calculated as the total number of seizures in the interval divided by the number of days with available seizure data in the interval, multiplied by 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Global Impression of Change in Target Behavior | End of the double-blind 17 week treatment period | Caregiver global impression of change in target behavior during the double-blind treatment period of ganaxolone compared to placebo. Investigators and caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives. |
| Clinical Global Impression of Improvement - Parent/Caregiver | End of the double-blind 17 week treatment period | Clinical global impression of improvement during the double-blind treatment period of ganaxolone compared to placebo. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses. |
| Clinical Global Impression of Improvement - Clinician | [Time Frame: End of the double-blind 17 week treatment period] | Clinical global impression of improvement during the double-blind treatment period of ganaxolone compared to placebo |
| Caregiver Global Impression of Change in Attention | End of the double-blind 17 week treatment period | Caregiver global impression of change in attention during the double-blind treatment period of ganaxolone compared to placebo. Investigators and caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives |
| Arithmetic Change in Longest Seizure Free Interval, Based on Primary Seizure Types | End of the double-blind 17 week treatment period | Arithmetic change in longest seizure free interval, based on primary seizure types during the double-blind treatment period of ganaxolone compared to placebo |
| Caregiver Global Impression of Change in Seizure Intensity and Duration | End of the double-blind 17 week treatment period | Caregiver global impression of change in seizure intensity and duration during the double-blind treatment period of ganaxolone compared to placebo. CGI-C is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. |
| Percentage of Seizure-free Days for Major Motor Seizure Types | End of the double-blind 17 week treatment period | Percentage of Seizure-free Days for Major Motor Seizure types during the double-blind treatment period of ganaxolone compared to placebo. The major motor seizure types include bilateral tonic (sustained motor activity = 3 seconds), generalized tonic-clonic, atonic/drop, bilateral clonic, and focal to bilateral tonic-clonic. |
Countries
Australia, France, Israel, Italy, Poland, Russia, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo suspension 3x's /day for 17 weeks
Placebo: inactive | 51 |
| Ganaxolone ganaxolone suspension (50 mg/ml) 3x's /day for 17 weeks
ganaxolone: active drug | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Ganaxolone | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 6.78 years STANDARD_DEVIATION 4.705 | 7.26 years STANDARD_DEVIATION 4.547 | 7.73 years STANDARD_DEVIATION 4.382 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 87 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 93 Participants | 47 Participants |
| Region of Enrollment Australia | 4 participants | 6 participants | 2 participants |
| Region of Enrollment France | 3 participants | 6 participants | 3 participants |
| Region of Enrollment Israel | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Italy | 9 participants | 15 participants | 6 participants |
| Region of Enrollment Poland | 5 participants | 10 participants | 5 participants |
| Region of Enrollment Russia | 7 participants | 14 participants | 7 participants |
| Region of Enrollment United Kingdom | 4 participants | 7 participants | 3 participants |
| Region of Enrollment United States | 18 participants | 42 participants | 24 participants |
| Sex: Female, Male Female | 39 Participants | 80 Participants | 41 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 45 / 51 | 43 / 50 |
| serious Total, serious adverse events | 5 / 51 | 6 / 50 |
Outcome results
Primary
Summary of 28-day Seizure Frequency for Major Motor Seizure Types
Summary of 28-day seizure frequency for Major Motor Seizure Types during the double-blind treatment period relative to the 6-week prospective baseline period Note: Summaries are based on the sum of the individual seizures, the countable seizures, and the clusters with uncountable seizures (each cluster with uncountable seizures counts as 1 seizure). Within the baseline and post baseline intervals, 28-day seizure frequency was calculated as the total number of seizures in the interval divided by the number of days with available seizure data in the interval, multiplied by 28.
Time frame: End of the double-blind 17 week treatment period
Population: ITT Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Summary of 28-day Seizure Frequency for Major Motor Seizure Types | Baseline (Median) | 49.17 Seizures per day |
| Placebo | Summary of 28-day Seizure Frequency for Major Motor Seizure Types | 17 week-post baseline phase (Median) | 55.50 Seizures per day |
| Ganaxolone | Summary of 28-day Seizure Frequency for Major Motor Seizure Types | Baseline (Median) | 54.00 Seizures per day |
| Ganaxolone | Summary of 28-day Seizure Frequency for Major Motor Seizure Types | 17 week-post baseline phase (Median) | 45.03 Seizures per day |
Secondary
Arithmetic Change in Longest Seizure Free Interval, Based on Primary Seizure Types
Arithmetic change in longest seizure free interval, based on primary seizure types during the double-blind treatment period of ganaxolone compared to placebo
Time frame: End of the double-blind 17 week treatment period
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Arithmetic Change in Longest Seizure Free Interval, Based on Primary Seizure Types | -4.63 days | Standard Deviation 14.867 |
| Ganaxolone | Arithmetic Change in Longest Seizure Free Interval, Based on Primary Seizure Types | -0.02 days | Standard Deviation 9.376 |
Secondary
Caregiver Global Impression of Change in Attention
Caregiver global impression of change in attention during the double-blind treatment period of ganaxolone compared to placebo. Investigators and caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives
Time frame: End of the double-blind 17 week treatment period
Population: Per Protocol Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Caregiver Global Impression of Change in Attention | Minimally Improved - Visit 5 (End of Week 17) | 14 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | Minimally Worse - Visit 5 (End of Week 17) | 1 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | Much Improved - Visit 5 (End of Week 17) | 7 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | Much Worse - Visit 5 (End of Week 17) | 1 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | No Change - Visit 5 (End of Week 17) | 23 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | Very Much Worse - Visit 5 (End of Week 17) | 0 Participants |
| Placebo | Caregiver Global Impression of Change in Attention | Very Much Improved - Visit 5 (End of Week 17) | 1 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Very Much Worse - Visit 5 (End of Week 17) | 1 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Very Much Improved - Visit 5 (End of Week 17) | 1 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Much Improved - Visit 5 (End of Week 17) | 2 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Minimally Improved - Visit 5 (End of Week 17) | 21 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | No Change - Visit 5 (End of Week 17) | 18 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Minimally Worse - Visit 5 (End of Week 17) | 1 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Attention | Much Worse - Visit 5 (End of Week 17) | 1 Participants |
Secondary
Caregiver Global Impression of Change in Seizure Intensity and Duration
Caregiver global impression of change in seizure intensity and duration during the double-blind treatment period of ganaxolone compared to placebo. CGI-C is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Time frame: End of the double-blind 17 week treatment period
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | Minimally Improved - Visit 5 (End of Week 17) | 11 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | 4Minimally Worse - Visit 5 (End of Week 17) | 5 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | Much Improved - Visit 5 (End of Week 17) | 5 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | Much Worse - Visit 5 (End of Week 17) | 4 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | No Change - Visit 5 (End of Week 17) | 21 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | Very Much Worse - Visit 5 (End of Week 17) | 0 Participants |
| Placebo | Caregiver Global Impression of Change in Seizure Intensity and Duration | Very Much Improved - Visit 5 (End of Week 17) | 1 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | Very Much Worse - Visit 5 (End of Week 17) | 2 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | Very Much Improved - Visit 5 (End of Week 17) | 2 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | Much Improved - Visit 5 (End of Week 17) | 15 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | Minimally Improved - Visit 5 (End of Week 17) | 11 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | No Change - Visit 5 (End of Week 17) | 10 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | 4Minimally Worse - Visit 5 (End of Week 17) | 3 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Seizure Intensity and Duration | Much Worse - Visit 5 (End of Week 17) | 2 Participants |
Secondary
Caregiver Global Impression of Change in Target Behavior
Caregiver global impression of change in target behavior during the double-blind treatment period of ganaxolone compared to placebo. Investigators and caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives.
Time frame: End of the double-blind 17 week treatment period
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Caregiver Global Impression of Change in Target Behavior | Minimally Improved - Visit 5 (End of Week 17) | 14 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | Minimally Worse - Visit 5 (End of Week 17) | 1 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | Much Improved - Visit 5 (End of Week 17) | 6 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | Much Worse - Visit 5 (End of Week 17) | 2 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | No Change - Visit 5 (End of Week 17) | 22 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | Very Much Worse - Visit 5 (End of Week 17) | 1 Participants |
| Placebo | Caregiver Global Impression of Change in Target Behavior | Very Much Improved - Visit 5 (End of Week 17) | 0 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Very Much Worse - Visit 5 (End of Week 17) | 0 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Very Much Improved - Visit 5 (End of Week 17) | 0 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Much Improved - Visit 5 (End of Week 17) | 4 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Minimally Improved - Visit 5 (End of Week 17) | 20 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | No Change - Visit 5 (End of Week 17) | 19 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Minimally Worse - Visit 5 (End of Week 17) | 2 Participants |
| Ganaxolone | Caregiver Global Impression of Change in Target Behavior | Much Worse - Visit 5 (End of Week 17) | 0 Participants |
Secondary
Clinical Global Impression of Improvement - Clinician
Clinical global impression of improvement during the double-blind treatment period of ganaxolone compared to placebo
Time frame: [Time Frame: End of the double-blind 17 week treatment period]
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Clinical Global Impression of Improvement - Clinician | Much Worse - Visit 5 (End of Week 17) - Clinician | 0 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | Very Much Improved - Visit 5 (End of Week 17) - Clinician | 0 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | Much Improved - Visit 5 (End of Week 17) - Clinician | 7 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | Minimally Improved - Visit 5 (End of Week 17) - Clinician | 13 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | No Change - Visit 5 (End of Week 17) - Clinician | 19 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | Minimally Worse - Visit 5 (End of Week 17) - Clinician | 9 Participants |
| Placebo | Clinical Global Impression of Improvement - Clinician | Very Much Worse - Visit 5 (End of Week 17) - Clinician | 0 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Much Worse - Visit 5 (End of Week 17) - Clinician | 3 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | No Change - Visit 5 (End of Week 17) - Clinician | 16 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Very Much Improved - Visit 5 (End of Week 17) - Clinician | 0 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Very Much Worse - Visit 5 (End of Week 17) - Clinician | 1 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Much Improved - Visit 5 (End of Week 17) - Clinician | 7 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Minimally Worse - Visit 5 (End of Week 17) - Clinician | 2 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Clinician | Minimally Improved - Visit 5 (End of Week 17) - Clinician | 19 Participants |
Secondary
Clinical Global Impression of Improvement - Parent/Caregiver
Clinical global impression of improvement during the double-blind treatment period of ganaxolone compared to placebo. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses.
Time frame: End of the double-blind 17 week treatment period
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Minimally Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 13 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Minimally Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 4 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Much Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 7 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Much Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 1 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | No Change - Visit 5 (End of Week 17) - Parent/Caregiver | 22 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Very Much Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 0 Participants |
| Placebo | Clinical Global Impression of Improvement - Parent/Caregiver | Very Much Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 1 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Very Much Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 0 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Very Much Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 0 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Much Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 13 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Minimally Improved - Visit 5 (End of Week 17) - Parent/Caregiver | 17 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | No Change - Visit 5 (End of Week 17) - Parent/Caregiver | 14 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Minimally Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 2 Participants |
| Ganaxolone | Clinical Global Impression of Improvement - Parent/Caregiver | Much Worse - Visit 5 (End of Week 17) - Parent/Caregiver | 2 Participants |
Secondary
Percentage of Seizure-free Days for Major Motor Seizure Types
Percentage of Seizure-free Days for Major Motor Seizure types during the double-blind treatment period of ganaxolone compared to placebo. The major motor seizure types include bilateral tonic (sustained motor activity = 3 seconds), generalized tonic-clonic, atonic/drop, bilateral clonic, and focal to bilateral tonic-clonic.
Time frame: End of the double-blind 17 week treatment period
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Seizure-free Days for Major Motor Seizure Types | Baseline | 30.32 percent of seizure-free days | Standard Deviation 27.07 |
| Placebo | Percentage of Seizure-free Days for Major Motor Seizure Types | 17-week-Post-Baseline Phase | 36.17 percent of seizure-free days | Standard Deviation 30.932 |
| Placebo | Percentage of Seizure-free Days for Major Motor Seizure Types | Arithmetic Change from Baseline | 5.86 percent of seizure-free days | Standard Deviation 15.35 |
| Ganaxolone | Percentage of Seizure-free Days for Major Motor Seizure Types | Baseline | 22.57 percent of seizure-free days | Standard Deviation 25.761 |
| Ganaxolone | Percentage of Seizure-free Days for Major Motor Seizure Types | 17-week-Post-Baseline Phase | 32.29 percent of seizure-free days | Standard Deviation 30.615 |
| Ganaxolone | Percentage of Seizure-free Days for Major Motor Seizure Types | Arithmetic Change from Baseline | 9.62 percent of seizure-free days | Standard Deviation 21.364 |