Be informed. Get support. Be empowered.

Join a clinical trial to learn more about your seizures.

RegulaR, uncontRolled paRtial seizuRes?

epilepsy and new medicines you aRe not aloneBe empoweredOver 3 million people are living with seizures and epilepsy in

the U.S., and about 200,000 new cases are diagnosed annually.

clinical research studies (clinical trials) are necessary for the epilepsy community to bring forward new medications, and while treatment choices are available, still more are needed. this is because about 1 in 3 people taking anti-seizure (or antiepileptic) medication(s) still have seizures, and others get unwanted side effects.

if you are currently taking antiepilep-tic medication for partial-onset sei-zures and you are still experiencing seizures, we invite you to read on, since this clinical research study may be of interest to you.

Be empowered throuGh knowledGe

medical specialists are conducting this clini-cal trial to determine if a new investigational add-on (or ‘adjunctive’) anti epileptic medi-cation is effective in controlling partial-onset seizures when taken along with other antiepi-leptic medication(s).

if you have uncontrolled partial-onset seizures, learning more about your epilepsy through a daily seizure diary is an important step toward seizure management. a daily diary is included in this clinical research study. the information collected with the support of the medical specialists can empower you with greater knowledge about your health and treatment options.

“I have tried different medicines and I still get seizures.”

“i have tried different medications and i still get seizures.”

you are invited to take part in this epilepsy research study if you meet the study’s entry criteria. taking part in a clinical study can help you learn more about your health and your partial-onset seizures under the care and supervision of medical specialists.

For a limited time, these medical special-ists are enrolling people aged 16 and over, with a documented diagnosis of partial-on-set seizures. they want to see if this inves-tigational medication is effective in control-ling partial-onset seizures when it is added to antiepileptic medications that people are already taking.

to qualify for this study, people with epilepsy must be taking one or two antiepileptic med-ications, and have had at least 4 partial-on-set seizures over the past 4 weeks. if you are not currently being screened by the medical team, you can pre-screen for this clinical trial online at researchepilepsy.org.

partial seizures

this clinical research study involves people who regularly experience partial-onset sei-zures despite antiepileptic medication. these types of seizures usually last for 2 minutes or less. they are caused by unusual electrical activity in one part of the brain. these partial seizures are different for each person, but can cause some of the following symptoms:

• Stiffness

• Sudden sharp movements, like finger jerking

• Repetitive movements like chewing or picking at clothing

• Hearing, smelling, seeing, tasting, or feeling things that are not real

• sudden unexplained feeling of fear, joy, anger, sadness or nausea (feeling sick)

• Laughing, screaming, or crying

• Repetition of words or phrases

afterwards, people often feel tired or confused, weak, or forget what had happened.

“I have tried different medicines and I still get seizures.”

“i refuse to allow epilepsy to

control my life.”

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about the studyThis clinical study will see if an investigational medication is effective in controlling partial-onset seizures when it is added to your existing antiepileptic medication(s).

receive the investigational study medicine

receive placebo

Can i partiCipate in this study?

you may qualify to take part in this study if you:

are 16 years of age or over •

Were diagnosed with epilepsy • at least 12 months ago

are currently taking one or two • antiepileptic (or seizure-prevention) medications

Have had at least 4 partial-onset • seizures in the past 4 weeks

are willing to document your seizures • on a daily basis

can provide documentation of • your epilepsy diagnosis

Please note: if you are aged 16 or 17, a par-ent or legal guardian must take the study spe-cific screener and answer questions on your behalf. They must also agree to your partici-pation, and both of you will need to sign the informed consent document and agree to take part in this clinical study.

important information

there is no penalty and it’s no • problem if the research doctor is outside your insurer’s network

all study-related specialist care is • provided at no cost to you

compensation for time and travel • may be provided

to find out more and see if you qualify go to researchepilepsy.org now.

how is this study desiGned?

if you qualify and decide to take part in this clinical research study, you will continue to take your current antiepileptic medication(s). everyone who takes part in this research study will receive the investigational medication or a placebo (an inactive substance) at no cost. you have a 2 in 3 (67%) chance of receiving the investigational medication and a 1 in 3 (33%) chance of receiving placebo. the study medication will be taken once a day, along with your current antiepileptic medication(s) as directed.

what does the study involve?

to take part in this study, you must be willing to:

Visit the study center 5 times in 22 • weeks (compensation for time and travel may be provided)

Have your blood drawn for testing on • at least 4 separate occasions (as well as having other simple medical tests)

take the study medication every day • along with your current antiepileptic medication(s), as directed

Document your seizures daily, • recording whether or not you have had a seizure

at the end of the study, should you decide, you may also be eligible to take part in an optional ‘extension study’. this will allow you to take the investigational medication regardless of whether you received this or the placebo dur-ing the first part of the study. you will continue to be part of this research community and con-tinue to receive the care and oversight from the same team of medical specialists.

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?To find ouT more abouT The sTudy and To screen online go To

ResearchEpilepsy.org

what aBout my sChedule?

to help you take part in this study, talk to the research center staff about:

the availability of flexible clinic hours•

compensation for time and travel may • be provided

any questions you may have about the • schedule of visits and how long each visit may take

informed Consent

if you qualify to take part in this study, mem-bers of the study’s medical team will dis-cuss the details of this research study. this is called the ‘informed consent’ process. this helps you understand the key elements of the study including:

study design•

study medication •

tests you will have•

What you will be asked to do • (daily documentation of seizures)

Possible risks and benefits of the • study medication, examinations, and procedures

what are the Benefits of this study?

When you participate in this study, you will have an opportunity to become empowered by documenting and learning about your sei-zures, get more information about your epi-lepsy, and be part of an important research community.

During the study, you will receive at no cost to you (whether you are taking placebo or the investigational medication):

what are the risks of this study?

a member of the clinical study team will answer your questions and discuss the potential risks and benefits of this study with you. it is impor-tant to know that you will be monitored closely by medical specialists, and during each study visit, the medical staff will check your health and seizure status closely.

each person responds differently to differ-ent medications. that is why development of new antiepileptic medications is so impor-tant, and new medications can be evaluated only through clinical research studies like this one.

what aRe the Risks and benefits?

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care from a team of medical specialists•

study-related exa• ms, tests, and health and seizure tracking

study medication or placebo • (an inactive substance)

compensation for time and travel • may be provided

31. see if you pre-qualify by answering questions online at researchepilepsy.org or calling 1.888.570.3140

2. Give permission to send your information to the study center you select (if you pre-qualify).

3. talk with the medical specialist, study nurse or study coordinator when you are called to schedule a screening visit.

Be informed. Get support. Be empowered.

Join the clinical research team. Find out more and see if you qualify today!

Visit: ReseaRchepilepsy.oRg oR call: 1.888.570.3140

easy steps to see if you qualify to paRticipate