Epilepsies, Partial
Conditions
Keywords
partial onset epilepsy, adult epilepsy, partial seizures, anticonvulsant, catamenial epilepsy, adult partial onset epilepsy
Brief summary
To allow open-label extension to patients who have completed Protocol 1042-0600.
Detailed description
This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.
Interventions
DRUGganaxolone
liquid suspension dosed tid
Sponsors
Marinus Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who have completed all scheduled clinical study visits in the previous protocol 1042-0600 and have been deemed eligible (no major adverse events thought to be drug related) by the Investigator. 2. Diagnosis of epilepsy with CPS with or without secondarily generalized seizures according to the International League Against Epilepsy \[ILAE\] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and computerized tomography (CT) or magnetic resonance imaging (MRI) of the brain to rule out progressive structural lesions and electroencephalogram (EEG) or video EEG with results consistent with partial-onset epilepsy. 3. Male or female, 18 to 69 years of age (inclusive). \[Note: Participants who are \> 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.\] 4. A 12-lead electrocardiogram (ECG) without clinically significant abnormalities. 5. Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. 6. Able to participate for the full term of study. 7. Able to keep a seizure diary throughout the course of the study. 8. Sexually active women of childbearing potential must be using a medically acceptable method of birth control and have a negative qualitative serum beta-human chorionic growth hormone (beta HCG) pregnancy test result from a blood sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable form of birth control and qualitative serum βHCG pregnancy tests must be tested per protocol. 9. Participants with a history of depression must be stable and may be taking one antidepressant medication
Exclusion criteria
1. Presence of non-motor simple partial seizures only. 2. History of pseudoseizures in the last 5 years. 3. History of a primary generalized seizure in the last 5 years. 4. Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed). 5. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease. 6. Status epilepticus within the last year prior to randomization in 1042-0600 study. 7. Clinically unstable psychiatric disorder within the last 2 years. 8. Suicide attempt within the last 5 years or current significant suicidal ideation. 9. History of psychosis within the last 5 years. 10. Current use of neuroleptics for psychosis. 11. A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the participant at increased risk. 12. Known sensitivity or allergy to progesterone or related steroid compounds. 13. History of drug use or alcohol abuse within the past 5 years. 14. Sexually active women of childbearing potential (WCBP) who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a serum pregnancy test. 15. A history of chronic noncompliance with drug regimens. 16. Females who are currently breastfeeding. 17. Exposure to any other investigational drug within 30 days prior to randomization in 1042-0600 study. 18. Aspartate transaminase (AST) or alanine transaminase (ALT) levels \> 3 times the upper limit of normal (ULN) at screening. 19. Participant has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted. 20. Inability to withhold grapefruit and grapefruit juice from diet during the entire clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Baseline (Day 0) and Week 1 through Week 117 | Percent Change in weekly seizure frequency by treatment group compared to Baseline at the beginning of the double-blind study 1042-0600 is presented. Weekly seizure frequency included partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS) during Weeks 1 through Week 117. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders During Weeks 1 Through 117 | Baseline (Day 0) and Week 1 through Week 117 | Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600. |
| Number of Seizure-free Days During Weeks 1 Through 117 | Week 1 through Week 117 | Average number of seizure-free days per week for a given period was calculated as follows: (Total number of days with no seizures of any type during that period / number of days with seizure diary in that period) multiplied by 7. |
| Number of Seizure-free Participants | Day 1 through Day 224 (Week 32) | Number of Seizure-free participants is presented. |
| Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Baseline (Day 0) and up to Week 104 | QOLIE-31 was a survey of health-related QOL for adults with epilepsy and evaluated how much distress the participant feels about problems and worries related to epilepsy. It included 38 items grouped into eight multi-item subscales - Energy/Fatigue, Emotional Well-Being, Daily Activities/Social Functioning, Cognitive Functioning, Medication Effect, Seizure Worry, Overall Quality of Life (QoL) and Distress. The subscale scores and the total score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100; higher scores indicated better function. Baseline was defined as the last non-missing observation prior to the first dose in double-blind study 1042-0600. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
Countries
United States
Participant flow
Pre-assignment details
Participants who completed the previous double-blind controlled trial (Protocol 1042-0600, NCT00465517) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Ganaxolone Participants were administered GNX dose which ranged from 600 mg/day to 1500 mg/day oral liquid suspension. The dose titration schedule started with 300 mg three times daily (tid) (900 mg/day) and increased every 2 days by 100 mg tid (300 mg/day) to 500 mg tid (1500 mg/day). Participants who were able to tolerate the starting dose of 900 mg/day, were moved to increase dose of 1200 mg/day for 2 days, and then to 1500 mg/day until the optimal dose for efficacy and tolerability was achieved. | 123 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | <50% reduction in seizure frequency on or after Visit 7 | 18 |
| Overall Study | Adverse Event | 13 |
| Overall Study | Discretion of the investigator or sponsor | 2 |
| Overall Study | Insufficient clinical response | 36 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 2 |
| Overall Study | Sponsor closure of study | 21 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | Ganaxolone |
|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 11.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 123 |
| other Total, other adverse events | 103 / 123 |
| serious Total, serious adverse events | 15 / 123 |
Outcome results
Primary
Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117
Percent Change in weekly seizure frequency by treatment group compared to Baseline at the beginning of the double-blind study 1042-0600 is presented. Weekly seizure frequency included partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS) during Weeks 1 through Week 117. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Time frame: Baseline (Day 0) and Week 1 through Week 117
Population: Intent-To-Treat (ITT) Population included all participants who received at least 1 dose of open-label study medication. Only participants who received at least 1 dose of ganaxolone in the open-label (OL) study (1042-0601), had seizure diary data for Baseline (from double-blind study 1042-0600), and who had data from at least 7 seizure diaries in the open-label study (1042-0601) were included. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >13-26 | -19.6 Percent Change | Standard Deviation 42.38 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >26-39 | -37.7 Percent Change | Standard Deviation 33.79 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >39-52 | -29.1 Percent Change | Standard Deviation 51.26 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >78-91 | -38.8 Percent Change | Standard Deviation 66.24 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >104-117 | -93.3 Percent Change | — |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks 1-10 | -14.8 Percent Change | Standard Deviation 54.86 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks 1-13 | -14.0 Percent Change | Standard Deviation 52.91 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >52-65 | -29.9 Percent Change | Standard Deviation 51.85 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >65-78 | -41.4 Percent Change | Standard Deviation 38.21 |
| GNX/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >91-104 | -69.4 Percent Change | Standard Deviation 43.96 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >13-26 | -19.8 Percent Change | Standard Deviation 56.43 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >78-91 | -43.6 Percent Change | Standard Deviation 37.6 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >26-39 | -48.6 Percent Change | Standard Deviation 37.54 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks 1-13 | -13.7 Percent Change | Standard Deviation 65.6 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >39-52 | -42.9 Percent Change | Standard Deviation 59.81 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >91-104 | -100 Percent Change | — |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >65-78 | -67.7 Percent Change | Standard Deviation 23.09 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks >52-65 | -43.1 Percent Change | Standard Deviation 59.45 |
| PBO/GNX | Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117 | Weeks 1-10 | -12.3 Percent Change | Standard Deviation 64.08 |
Secondary
Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire
QOLIE-31 was a survey of health-related QOL for adults with epilepsy and evaluated how much distress the participant feels about problems and worries related to epilepsy. It included 38 items grouped into eight multi-item subscales - Energy/Fatigue, Emotional Well-Being, Daily Activities/Social Functioning, Cognitive Functioning, Medication Effect, Seizure Worry, Overall Quality of Life (QoL) and Distress. The subscale scores and the total score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100; higher scores indicated better function. Baseline was defined as the last non-missing observation prior to the first dose in double-blind study 1042-0600. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 0) and up to Week 104
Population: ITT Population. Only participants who received at least 1 dose of ganaxolone in the open-label study (1042-0601), had seizure diary data for Baseline (from double-blind study 1042-0600), and who had data from at least 7 seizure diaries in the open-label study (1042-0601) were included. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Emotional Well-Being | -4.7 Scores on a Scale | Standard Deviation 13.83 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Energy/Fatigue | -5.7 Scores on a Scale | Standard Deviation 18.16 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Social Function | -3.6 Scores on a Scale | Standard Deviation 24.67 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Cognitive | 2.1 Scores on a Scale | Standard Deviation 19.91 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Medication Effect | -3.9 Scores on a Scale | Standard Deviation 25.28 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Seizure Worry | 3.6 Scores on a Scale | Standard Deviation 25.4 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Overall QoL | -3.8 Scores on a Scale | Standard Deviation 17.26 |
| GNX/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Distress | -5.5 Scores on a Scale | Standard Deviation 18.49 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Distress | 0.7 Scores on a Scale | Standard Deviation 21.92 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Emotional Well-Being | 3.3 Scores on a Scale | Standard Deviation 22.13 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Cognitive | 2.9 Scores on a Scale | Standard Deviation 18.04 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Medication Effect | 0.9 Scores on a Scale | Standard Deviation 26.85 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Energy/Fatigue | 3.9 Scores on a Scale | Standard Deviation 17.2 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Overall QoL | 0.0 Scores on a Scale | Standard Deviation 15.17 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Social Function | 8.4 Scores on a Scale | Standard Deviation 21.44 |
| PBO/GNX | Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire | Seizure Worry | -3.1 Scores on a Scale | Standard Deviation 35.73 |
Secondary
Number of Responders During Weeks 1 Through 117
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Time frame: Baseline (Day 0) and Week 1 through Week 117
Population: ITT Population. Only subjects who received at least 1 dose of ganaxolone in the open-label study (1042-0601), had seizure diary data for Baseline (from double-blind study 1042-0600), and who had data from at least 7 seizure diaries in the open-label study (1042-0601) were included. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >52-65 | 8 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >26-39 | 11 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >65-78 | 6 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >39-52 | 10 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >78-91 | 4 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >13-26 | 12 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >91-104 | 3 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks 1-10 | 22 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >104-117 | 1 Participants |
| GNX/GNX | Number of Responders During Weeks 1 Through 117 | Weeks 1-13 | 19 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >26-39 | 12 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks 1-13 | 12 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >13-26 | 8 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >39-52 | 10 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks 1-10 | 11 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >52-65 | 8 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >65-78 | 11 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >78-91 | 4 Participants |
| PBO/GNX | Number of Responders During Weeks 1 Through 117 | Weeks >91-104 | 1 Participants |
Secondary
Number of Seizure-free Days During Weeks 1 Through 117
Average number of seizure-free days per week for a given period was calculated as follows: (Total number of days with no seizures of any type during that period / number of days with seizure diary in that period) multiplied by 7.
Time frame: Week 1 through Week 117
Population: ITT Population. Only participants who received at least 1 dose of ganaxolone in the open-label study (1042-0601), had seizure diary data for Baseline (from double-blind study 1042-0600), and who had data from at least 7 seizure diaries in the open-label study (1042-0601) were included. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >104-117 | 6.9 Seizure free days | — |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks 1-13 | 4.8 Seizure free days | Standard Deviation 1.97 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >13-26 | 5.1 Seizure free days | Standard Deviation 1.54 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >26-39 | 5.2 Seizure free days | Standard Deviation 1.69 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >39-52 | 5.4 Seizure free days | Standard Deviation 1.66 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >52-65 | 5.1 Seizure free days | Standard Deviation 2.11 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >78-91 | 5.4 Seizure free days | Standard Deviation 2.32 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks 1-10 | 4.8 Seizure free days | Standard Deviation 1.99 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >65-78 | 5.3 Seizure free days | Standard Deviation 1.93 |
| GNX/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >91-104 | 5.6 Seizure free days | Standard Deviation 2.56 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >65-78 | 5.7 Seizure free days | Standard Deviation 1.61 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks 1-13 | 5.0 Seizure free days | Standard Deviation 1.85 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >78-91 | 4.7 Seizure free days | Standard Deviation 1.88 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >13-26 | 5.3 Seizure free days | Standard Deviation 1.4 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks 1-10 | 5.0 Seizure free days | Standard Deviation 1.81 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >26-39 | 5.4 Seizure free days | Standard Deviation 1.75 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >52-65 | 5.2 Seizure free days | Standard Deviation 2.1 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >39-52 | 5.4 Seizure free days | Standard Deviation 1.56 |
| PBO/GNX | Number of Seizure-free Days During Weeks 1 Through 117 | Weeks >91-104 | 6.8 Seizure free days | — |
Secondary
Number of Seizure-free Participants
Number of Seizure-free participants is presented.
Time frame: Day 1 through Day 224 (Week 32)
Population: ITT Population. Only participants who received at least 1 dose of ganaxolone in the open-label study (1042-0601), had seizure diary data for Baseline (from double-blind study 1042-0600), and who had data from at least 7 seizure diaries in the open-label study (1042-0601) were included. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GNX/GNX | Number of Seizure-free Participants | >= 28 days (4 weeks) | 20 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=91 days (13 weeks) | 4 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=182 days (26 weeks) | 0 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=119 days (17 weeks) | 43 Participants |
| GNX/GNX | Number of Seizure-free Participants | >= 56 days (8 weeks) | 6 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=133 days (19 weeks) | 3 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=224 days (32 weeks) | 0 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=154 days (22 weeks) | 3 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=70 days (10 weeks) | 4 Participants |
| GNX/GNX | Number of Seizure-free Participants | >=1 day | 75 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=224 days (32 weeks) | 18 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=1 day | 41 Participants |
| PBO/GNX | Number of Seizure-free Participants | >= 28 days (4 weeks) | 38 Participants |
| PBO/GNX | Number of Seizure-free Participants | >= 56 days (8 weeks) | 33 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=182 days (26 weeks) | 20 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=70 days (10 weeks) | 31 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=91 days (13 weeks) | 29 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=119 days (17 weeks) | 27 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=133 days (19 weeks) | 27 Participants |
| PBO/GNX | Number of Seizure-free Participants | >=154 days (22 weeks) | 25 Participants |