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Participate in a Clinical Trial
A clinical trial is a research study using human volunteers designed to determine the safety and effectiveness of a drug, biologic (such as a vaccine), device, or other treatment or behavioral intervention. Clinical trials are the fastest way to find treatments that work in people and methods to improve health. Participants may also gain access to new research treatments before they are widely available and help others by contributing to medical research.
For information about clinical trials, go to: www.clinicaltrials.gov
In an observational study, researchers observe individuals without changing their treatment to learn more about a disease or medical condition. The Epilepsy Genome/Phenome Project (EPGP) is an observational study sponsored by the National Institutes of Health. EPGP is enrolling two types of participants:
- A person who has been diagnosed with epilepsy who also has
a brother or sister with epilepsy of unknown cause; OR
- A person who has been diagnosed with epilepsy due to
Infantile Spasms, Lennox-Gastaut Syndrome, Polymicrogyria,
Periventricular Heterotopia
Participation involves a blood draw, interviews, and review of medical records.
For more information: www.epgp.org or 1-888-279 -EPGP (3747).
 CHARLES L. SHOR FOUNDATION FOR EPILEPSY RESEARCH FUNDING STRESS MANAGEMENT INTERVENTION FOR LIVING WITH EPILEPSY (SMILE) STUDY
Stress Management Intervention for Living with Epilepsy (SMILE) is a groundbreaking study focused on determining whether:
- Stress can cause seizures
- A reduction in stress can keep seizures from occurring at all
The study, funded by the Charles L Shor Foundation for Epilepsy Research, is being conducted by researchers at the University of Cincinnati. It combines an Integrative Medicine approach (treatment of the mind, body and soul) with seizure prediction methods including:
- Stress reduction using non-medication, alternative treatment approach (progressive muscle relaxation plus diaphragmatic breathing vs. attention practice twice daily)
- Smartphone monitoring of stress and other triggers multiple times per day. (8-week seizure baseline using smartphone for stress and mood variables plus seizures
For more information on the study, please visit www.shorfoundation.org/SMILE.html.
UPSHER-SMITH LABORATORIES BEGINS PHASE III STUDY OF INTRANASAL MIDAZOLAM
FOR RESCUE TREATMENT OF SEIZURE CLUSTERS IN EPILEPSY PATIENTS
Research strives to address unmet needs for treatment of seizure clusters in the outpatient setting
Maple Grove, MN – July 18, 2011 – Upsher-Smith Laboratories, Inc. announced today the initiation of a Phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA).
The Phase III randomized, double-blind, placebo-controlled study, ARTEMIS1 [“Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray”], will compare intranasal midazolam, a benzodiazepine, with an intranasal placebo in males and females ages 14 to 65 years with a diagnosis of seizure clusters and who have a competent caregiver. The seizure clusters must have a pattern that is different from the individual’s other non-cluster seizure activity and must be recognizable by a caregiver. USL261 may allow a caregiver to deliver an appropriate dose of the medication intranasally to an individual who is experiencing an intermittent bout of increased seizure activity. It is intended that this administration will not require an active inhalation by the patient.
The trial will enroll eligible patients with partial or generalized seizures who are on stable AED regimens. USL261 is the subject of a global Phase III clinical trial (ARTEMIS1), being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
For more information on the study, please visit http://www.seizureclusterstudy.com/.
ROSE (RADIOSURGERY OR OPEN SURGERY FOR EPILEPSY)
Epilepsy surgery can be an effective therapy for some people whose seizures cannot be controlled by anticonvulsant medications. A new clinical trial is testing whether a minimally-invasive approach called radiosurgery is as effective as standard open surgery at reducing or eliminating seizures in patients with medically refractory partial epilepsy. Radiosurgery is a radiation procedure already in use to treat tumors and other abnormalities of the brain. The Gamma Knife® radiosurgery instrument used in this study uses tightly focused beams of radiation to target the seizure focus, rather than removing it with open surgery.
The ROSE Trial (Radiosurgery or Open Surgery for Epilepsy), sponsored by the National Institutes of Health and Elekta, the company that manufactures the Gamma Knife, is designed to compare the two different surgical procedures on outcomes including seizure frequency, language impairment (sometimes caused by surgery), cost of the procedures, and effects on quality of life. NIH will possibly have to close the study before it is complete if patient enrollment does not increase within the next few months. The ROSE Trial is being conducted in major epilepsy centers across the US and Canada.
For more information about this trial and to locate an enrolling center near you please visit clinicaltrials.gov using this link http://www.clinicaltrials.gov/ct2/show/NCT00860145?term=radiosurgery+and+epilepsy&rank=1 or visit the ROSE study website at http://epilepsysurgery-rosetrial.com/
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