A New Wave of Hope
Join Us in the Quest to Help Advance Treatment for Developmental and Epileptic Encephalopathies (DEE)
A clinical study to potentially help reduce the number of seizures in children and adults with a severe form of epilepsy that affects learning and development. Lennox-Gastaut Syndrome (LGS) is one example of a DEE but many other diagnoses fall within this spectrum.
WHO CAN TAKE PART?
Eligible participants include individuals aged 2 to 65 who have been diagnosed with Developmental and Epileptic Encephalopathies (DEE) and have experienced the onset of seizures between birth to 8 years old for people with Lennox-Gastaut Syndrome (LGS) or birth to 5 years old for people with DEE (other). Additionally, they have experienced an average of four seizures per month over the past three months.
Patients with Dravet Syndrome may qualify for the DEEp SEA Study. To learn more about the DEEp SEA study please visit the study website.
Participants who may be eligible to join:
- Have been diagnosed with DEE, such as LGS or other.
- Are between the ages of 2 and 65 years old.
- Have experienced seizure onset between:
- Birth and 8 years old for people with LGS.
- Birth and 5 years old for people with DEE (other)
- Have had an average of 4 seizures per month during the last 3 months.
- Are willing and able or have a carer who can maintain study diaries throughout the DEEp OCEAN study.
What to expect during the DEEp OCEAN study
SCREENING
To take part in this study, the participant will need to be evaluated by a doctor to determine eligibility. It may take up to five weeks to evaluate a potential participant’s eligibility for the study.
SCREENING
To take part in this study, the participant will need to be evaluated by a doctor to determine eligibility. It may take up to five weeks to evaluate a potential participant’s eligibility for the study.
STUDY TREATMENT
Eligible participants will take part in a 15-week treatment period. Participants will be randomly assigned to receive a liquid formulation of either the investigational drug or placebo. The placebo will look and taste like the investigational drug being tested in the clinical study but has no active ingredients in it.
During the study, participants can expect at least 6 on-site visits for tests and evaluations, as well as 3 telephone visits to review progress. Participants or carers will need to maintain electronic diaries throughout the study.
STUDY TREATMENT
During the study, participants can expect at least 6 on-site visits for tests and evaluations, as well as 3 telephone visits to review progress. Participants or carers will need to maintain electronic diaries throughout the study.
OPEN-LABEL EXTENSION
Participants who complete the last visit of the study treatment period can continue in an open-label extension study (OLE). During the OLE, all participants will receive the investigational drug.
OPEN-LABEL EXTENSION
FOLLOW-UP
Participants who choose not to enter the open-label extension study will continue their participation until the follow-up.
.svg){kind=small}
.svg){kind=small}
