Image

A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder

Exploring ZX008 for CDKL5 Deficiency Disorder: Safety and Effects Study

Recruiting
1-35 years
All
Phase 3

This study is about finding out how well a new medicine called ZX008 works and how safe it is for people with a condition called CDKL5 Deficiency Disorder (CDD). CDD is a problem that affects the brain and causes seizures. Seizures are like sudden bursts of electricity in the brain that make it hard for the person to control their body. This study will include children and adults who have a hard time controlling their seizures even though they already take medicine for it. The study has two parts.

Part 1 lasts 20 weeks and involves taking the new medicine or a dummy pill (placebo) in addition to their current medicine. Part 2 is a longer 54-week part where everyone gets the real medicine to see how it works over time. To join, participants need to have tried at least two other seizure medicines without success, and must be between 1 to 35 years old.

Key points to consider:

  • The first part of the study is 20 weeks long.
  • Participants will need to have regular check-ups.
  • The study involves taking a new medicine along with current treatments.

Study details
    CDKL5 Deficiency Disorder
    Generalized Tonic Clonic Seizure
    Epileptic Spasm
    Refractory Seizures

NCT05064878

Zogenix, Inc.

24 November 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.