Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)
[Study Sponsor: Medtronic Navigation Inc.]
The purpose of this study is to evaluate the safety and efficacy of the Visualase® MRI-Guided Laser Ablation System (Visualase System).
Key Inclusion Criteria:
- History of drug-resistant mesial temporal lobe epilepsy (MTLE)
- If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months
- On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use
- An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month
- Seizure symptoms and/or auras compatible with MTLE
- Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE
- MRI has evidence consistent with mesial temporal lobe sclerosis
- Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure
This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT02844465
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy (OPUS)
[Study Sponsor: Biogen]
The purpose of this study is to determine the efficacy of intravenous natalizumab adjunctive therapy on seizure frequency due to drug-resistant focal epilepsy.
Key Inclusion Criteria:
- Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with multifocal epilepsy may be included if all other entry criteria are met.
- Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in combination) [Kwan 2010].
- Experiences 6 or more seizures during the 6-week prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period
This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT03283371
For questions regarding the above studies, please contact:
Eddie Soto, CCRP
Research Specialist, Senior
University of Arizona, Health Sciences, Department of Neurology
1501 N. Campbell Avenue
Tucson, AZ 85724
Fax: (520) 626-4903