RecruitingPHASE3INTERVENTIONAL

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

This research, called the DEEP SEA Study, is testing a new medication, LP352, for children and adults with Dravet Syndrome. This condition causes severe seizures. The main goal is to find out if LP352 can effectively reduce seizures and if it is safe and well-tolerated. Some participants will receive LP352, while others will receive a placebo – a pill that looks the same but contains no active medicine. This helps researchers understand the true effects of the new medication. The study will last about two years and involves different stages, including starting the medication, using it regularly, and then carefully stopping it. We are looking for people aged 2 to 65 to join.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Longboard Pharmaceuticals

Enrolment target

160

Start

25 Sep 2024

Estimated completion

02 Oct 2026

Dravet Syndrome

What is this study about?

Dravet Syndrome is a serious type of epilepsy that usually starts in the first year of life and causes frequent, severe seizures. It can also lead to other health challenges. Doctors are always looking for new and better ways to help people living with this condition. That's where studies like this one come in.

This particular study is investigating a new potential treatment called LP352. The main goal is to see if LP352 can help reduce the number of seizures people with Dravet Syndrome experience. Researchers also want to make sure it's safe to use and that patients can take it without too many unpleasant side effects. This is a "Phase 3" study, which means it's one of the final steps before a new medication might be approved for wider use.

To get clear and reliable results, the study is designed very carefully. Some people will receive LP352, and others will receive a 'placebo' – a pill that looks identical but has no active medicine. Neither the participants nor their doctors will know who is getting which, to ensure the results are as fair as possible. By comparing the groups, researchers can figure out if LP352 really makes a difference.

Key takeaways

Tests a new medication (LP352) for Dravet Syndrome.
Compares LP352 to a dummy pill (placebo).
Aims to reduce seizures and check safety.
Involves children and adults aged 2-65.
Requires careful diary keeping of seizures.
Study duration is around 2 years.

Who may be eligible?

To join this study, children and adults must be between 2 and 65 years old and have a confirmed diagnosis of Dravet Syndrome. This means their seizures started between 1 and 20 months of age, and they've had specific types of seizures like prolonged generalized tonic-clonic or myoclonic seizures. They should currently be experiencing at least four countable motor seizures each month.

Participants also need to be taking 1 to 4 anti-seizure medications that have been at a steady dose for at least four weeks before starting the study. It's really important that the participant, or their parent/carer, is willing and able to keep a daily diary throughout the study to record seizures and other information.

There are also some reasons why someone might not be able to join. For example, if they have a history of infantile spasms, have been very unwell recently with seizures needing special hospital care, or have another serious brain condition. Also, people using certain medications or cannabis products with high levels of Delta-9-THC are not eligible.

Quick self-check

Are you between 2 and 65 years old?
Do you have a diagnosis of Dravet Syndrome?
Do you currently have at least 4 countable motor seizures per month?
Are you taking 1 to 4 stable anti-seizure medications?
Are you, or your carer, able to keep a daily seizure diary?
Have you not had infantile spasms in the past?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study will last for about two years. It starts with a 'screening' period where doctors check if you're suitable. If you qualify, you'll then enter the 'titration' period, where the study medication (LP352 or placebo) is slowly increased to the right dose. This is followed by a longer 'maintenance' period where you'll take the medication regularly. Throughout these phases, you'll visit the clinic for check-ups, and you or your carer will need to complete daily diaries to record your seizures and any side effects.

After the maintenance period, there will be a 'taper' period where the study medication is gradually reduced and then stopped. Finally, there's a 'follow-up' to make sure you're doing well after stopping the study treatment. You'll have regular visits to the study clinic, and doctors will carefully monitor your health and any changes in your seizures. All medications, tests, and medical care related to the study will be provided at no cost.

Potential risks and benefits

Potential benefits of joining the study include access to a new medication, LP352, which might help reduce your seizures, and close medical monitoring by specialists. However, there's no guarantee that LP352 will work for everyone, and some participants will receive a placebo, meaning their seizures might not improve. Potential risks could include side effects from LP352, which will be carefully monitored. There might also be inconvenience due to extra clinic visits and record-keeping. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (100)

Arkansas Children's Hospital - PIN
Little Rock, United States· Recruiting
Children's Hospital Los Angeles - PIN
Los Angeles, United States· Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, United States· Recruiting
The Stanford Division of Child Neurology
Palo Alto, United States· Recruiting
UCSF Children's Hospital
San Francisco, United States· Completed
Children's Hospital Colorado.
Aurora, United States· Recruiting
Children's National Medical Center
Washington D.C., United States· Recruiting
NW FL Clinical Research Group, LLC
Gulf Breeze, United States· Recruiting
Nicklaus Children's Hospital - PIN
Miami, United States· Recruiting
Research Institute of Orlando LLC
Orlando, United States· Completed
Pediatric Epilepsy and Neurology Specialists
Tampa, United States· Recruiting
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, United States· Completed

+88 more sites — see the official record for the full list.

Common questions

What is LP352?

LP352 is a new medication being tested to see if it can help reduce seizures in people with Dravet Syndrome.

What is a placebo?

A placebo is a dummy pill that looks just like the study medication but contains no active medicine. It helps researchers understand if the new drug truly works.

How long will I be in the study?

The study will last for about two years from start to finish.

Will I know if I'm getting LP352 or the placebo?

Neither you nor your study doctor will know whether you are receiving LP352 or the placebo during the main part of the study. This is called 'double-blind'.

Can I leave the study early?

Yes, you can choose to leave the study at any time, for any reason, without affecting your medical care.

How to find out more

Email contact via H. Lundbeck A/S

HQ_Medinfo@Lundbeck.com +45 36301311 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.