A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
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|ClinicalTrials.gov Identifier: NCT00465517|
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : October 30, 2009
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
|Condition or disease||Intervention/treatment||Phase|
|Partial Epilepsy Catamenial Epilepsy||Drug: Ganaxolone||Phase 2|
Subjects will undergo
- 8-week baseline seizure period
- Randomization to ganaxolone or placebo
- Dose titrate for 2 weeks followed by 8 weeks of maintenance.
- Eligible subjects will be offered participation in the open-label extension study.
- Those not entering open-label will undergo a 6-week dose de-escalation to gradually taper ganaxolone.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||November 2008|
Oral suspension 200-500 mg 3x/day
|Placebo Comparator: non-active drug||
Oral suspension 200-500 mg 3x/day
- Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including POS with or without secondary generalization, but not non-motor SPS] during the Maintenance Phase (Weeks 3 to 10). [ Time Frame: 10-16 weeks ]
- Change and percent change of mean weekly seizure frequency from baseline [ Time Frame: 10-16 weeks ]
- Change and percent change of weekly seizure frequency from baseline for each week after dosing [ Time Frame: 10-16 weeks ]
- Responder rate. Responders are defined as patients experiencing ≥50% of reduction in mean weekly seizure frequency during the maintenance period from the baseline [ Time Frame: 10-16weeks ]
- Number of seizure-free days [ Time Frame: 10-16 weeks ]
- Number of seizure-free subjects and seizure-free rate [ Time Frame: 10-16 weeks ]
- The weekly seizure frequencies, changes, and percent changes from baseline for each seizure subtype: POS with or without secondary generalization, but not non-motor SPS [ Time Frame: 10-16 weeks ]
- Seizure severity questionnaires and quality of life surveys changes [ Time Frame: 10 weeks ]
- Change in rate of seizures in catamenial epilepsy [ Time Frame: 10-16 weeks ]
- Weekly seizure frequency for each week after dosing. [ Time Frame: 10-16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465517