Clinical Trial: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR)

The VALOR study is investigating whether Lacosamide (Vimpat®)—when taken with current anti-epileptic medicine—helps decrease the number of seizures patients experience. This study enrolls children and adults who are at least 4 years or older, have epilepsy with primary generalized tonic-clonic seizures, had at least 2 seizures in the past 12 weeks, and are on a stable dose of anti-epileptic medicines. Patients have a 50% chance of receiving placebo; they have the opportunity to receive Lacosamide for another two years afterwards in an open-label extension study. The study is running in a total of 23 countries, including the United States.

Eligibility Criteria:

Ages Eligible for Study: 4 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalizedtonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
  • Subject has 3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
  • If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
  • Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Antiepileptic drugs (AEDs) OR 1 to 3 AEDs (with 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS)
  • Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

 

Exclusion Criteria:

  • History of partial onset seizures or EEG findings indicating partial onset seizures
  • Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
  • Lifetime history of suicide attempt, or suicidal ideation in past 6 months
  • Women of child bearing potential must practice contraception according to protocol requirements
  • Regular use of clozapine, monoamine oxidase (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
  • Use of Vigabatrin within the last 6 months

Mayor Emanuel Interviews Singer, Actor and “Hamilton” Star Miguel Cervantes on “Chicago Stories”

On this week’s episode of “Chicago Stories” the star of Chicago’s “Hamilton” Miguel Cervantes gives Mayor Emanuel his take on the smash-hit musical, shares the story of his hard-won career, and talks about his biggest role of all as “Dad” and raising awareness for childhood epilepsy.

Born and raised in Dallas, Miguel wasn’t interested in theater growing up, at least not at first, but an audition for a local production in sixth grade planted the first step to a journey that took him to Dallas’ Booker T. Washington High School for the Performing Arts, Boston’s Emerson College, and then finally the bright lights of Broadway?—?or so he thought.

“When I graduated I went right to New York as the big fish in my school,” Miguel said. “I thought: ‘this is great, this is easy, this is going to be awesome,’ and then crash and burn.”

As Miguel told Mayor Emanuel, he wasn’t ready. (Though, as Mayor Emanuel told Miguel, the real problem was New York wasn’t ready for him.)

After a brief return home, Miguel hooked up with friends in Boston and embarked on an artistic rebirth that eventually brought him back to the Big Apple, but this time to a mix of Broadway, Off-Broadway, and touring productions.

“Opportunity comes at its own pace,” Miguel said, “and sometimes your opportunity is not when you’re 21 when you think you’re ready?—?that may not be the right time for you.”

For Miguel, opportunity came in a big way in 2016 when the mega-hit “Hamilton” was looking to recast its famous title role. Immediately once auditions started, Miguel could tell something was different.

“Three weeks later, after four auditions, I called my wife and said ‘I think we’re moving to Chicago,’” Miguel said.

Miguel’s biggest role of all though has been as “Dad” to his six-year-old son and two-year-old daughter Adelaide, who at seven-months-old was diagnosed with epilepsy just as “Hamilton” was coming into his life.

As devastating as childhood epilepsy is, the news got worse after doctors discovered Adelaide had “infantile spasms,” a particularly devastating form of epilepsy that can lead to severe developmental and cognitive delays.

Not knowing where to go or who to turn to, Miguel and his wife Kelly connected with the Chicago-based Citizens United in Research for Epilepsy, or “CURE,” the nation’s largest non-governmental organization funding epilepsy research.

“We got here terrified, just absolutely terrified,” Miguel told Mayor Emanuel. “And we come to Chicago and the folks at CURE wrapped their arms around us and said ‘we got you here.’”

Since then both Miguel and Kelly have become passionate advocates for epilepsy awareness through CURE, including their My Shot at Epilepsy fundraising campaign and the #MyShotAtEpilepsy Challenge.

Today, 3.4 million Americans suffer from epilepsy, including 470,000 children, while an estimated 65 million people currently life with epilepsy worldwide. Meanwhile, research is still underfunded, and comprehensive treatment for families like the Cervantes’ is still a long way off.

“What we say is we may not be able to do so much for [Adelaide]—what we can actually achieve in her life may be limited,” Miguel said, “but if we raise our voices and do everything that we can, at some point some parents will not have to go through what we have to go through.”

Be sure to listen to the full episode as Miguel and Mayor Emanuel talk about the impact of “Hamilton,” Chicago’s theater community and culture of giving back, and where Miguel hopes opportunity takes him next.

You can check out the full episode on iTunesSoundCloud, and Spotify.

April 2018 CURE Update

I took a brief break from overseeing CURE’s research efforts last week to attend a CURE Benefit in Boston hosted by Anne Finucane & Mike Barnicle as well as Susan & David Axelrod. I’m so grateful to them for being such wonderful hosts and would like to thank all those who attended. At the event, CURE’s founder Susan Axelrod spoke about the importance of epilepsy research and highlighted our plans to work with the Department of Defense on Post-Traumatic Epilepsy. I had the opportunity to speak about recent CURE-funded research that may lead to important diagnostic and treatment advances.

The 2018 Boston Benefit for the Cure was a wonderful opportunity to get together with members of our passionate community who are dedicated to finding a cure.

Couldn’t attend the Boston event? Read on… you can participate in other ways. Our next online webinar will feature news about promising anti-epileptic drugs in development. Or, if you’re looking to attend an event in-person, I’ve included information about CURE’s next Day of Science events as well as additional news and events that I’m excited to share with you.

Best regards,
Dr. Laura Lubbers

 

PROMISING ANTI-EPILEPTIC DRUGS IN DEVELOPMENT ? WEBINAR

This free webinar will outline therapies in development for epilepsy and seizures, including promising therapies for patients with treatment-resistant epilepsy and children with severe epilepsy. The webinar will also focus on drugs that may not only reduce seizures, but improve treatment of the underlying disease.

The webinar will be presented by Dr. Jacqueline French, a professor of Neurology in the Comprehensive Epilepsy Center at NYU Langone School of Medicine and Founder/Director of the Epilepsy Study Consortium. Dr. French’s presentation will be followed by an interactive Q&A session.

The information session is scheduled for Wednesday, April 18, 2018 at 1pm EDT / 2pm CDT. The webinar is free, but you do need to register.