Arcade Study Criteria CDD & DUP15Q FAQ Resources Clinical Research Sponsor

Now Open: Seeking participants with CDKL5 deficiency disorder or duplication 15q syndrome for a new clinical study

Ovid Therapeutics is sponsoring a clinical research study called the ARCADE study. ARCADE will assess the effect of OV935, an investigational medicine, on the frequency of seizures in participants with CDKL5 deficiency disorder (CDD) or duplication 15q syndrome (Dup15q). The study will also examine the safety and tolerability of OV935 and how it works within the body.

What is the Arcade Study?

ARCADE is a Phase 2 open-label pilot study. A Phase 2 study typically evaluates different doses of a medicine that is in development. Open-label means the study participants know they will receive the investigational medicine. The term “pilot” indicates a primary step in the research process that will help determine if the study should be conducted in the same but larger manner in the future.  OV935 works in a new and different way, and it may be effective in controlling seizures. Four Phase I studies successfully evaluated healthy participants’ abilities to tolerate OV935. ARCADE is the first Phase 2 study of OV935 in children and adults with CDD or Dup15q. As with any clinical research study, all potential risks and benefits cannot be known in advance. Your child or the individual you care for will be closely monitored throughout the study so potential risks can be anticipated and addressed.

Study Details

The study enrolls 30 participants between the ages of 2 and 35 and lasts for 30 weeks

 

The ARCADE study will enroll approximately 30 participants between the ages of 2 and 35, including 15 children or adults with CDD and 15 children or adults with Dup15q. A parent or primary caregiver for the child will need to provide consent and assent, attend scheduled visits and participate in study assessments.

If your child or the individual you care for qualifies for ARCADE, participation will last approximately 30 weeks and include seven visits to the study medical center and four phone appointments. During visits, you will meet with the study team, which will include a doctor, nurse and other healthcare professionals. They will explain the study, answer all your questions and closely monitor participant health. During the phone appointments, you will discuss the seizure diary and any adverse events, or unexpected medical concerns, with a member of the study team.

At the end of ARCADE, you and your child, or the individual you care for, will have the opportunity to enroll in a two-year extension of this study.

The investigational medicine in ARCADE, referred to as OV935, will be provided at no charge by Ovid Therapeutics, the study sponsor. Ovid Therapeutics will also cover the cost of travel, lodging, childcare and other study-related costs. Please talk to your study team for details. 

Addressing an Unmet Medical Need

CDD and Dup15q are rare and complex diseases, and current treatment options help manage specific symptoms. Many children and adults with CDD or Dup15q receive multiple services, including physical, occupational and speech therapies that are beneficial in enhancing or maintaining quality of life. They may also take medications to help manage seizures. The purpose of the ARCADE study is to determine if the investigational medicine OV935 impacts the frequency of seizures experienced by children or adults with CDD and Dup15q.

By participating in ARCADE, your child, or the individual you care for, may help medical researchers learn more about CDD or Dup15q and potential future treatment options.

Who Qualifies?

To participate in the ARCADE study, individuals must meet the following criteria:

  • Has a documented diagnosis of CDD or Dup15q
  • Has a parent or caregiver who can provide consent and assent, attend scheduled visits and participate in study assessments
  • Is between the ages of 2 and 35
  • Has an average of at least three motor seizures per month

ARCADE also has other requirements that help ensure the safety of all participants. If your child or the individual you care for qualifies to participate in the study, these additional conditions will be reviewed with you by the team at your study medical center.

Take the prescreener to help determine if your child or the individual you care for with CDD or Dup15q may qualify for the ARCADE study.

What Is CDKL5 Deficiency Disorder (CDD)?

CDKL5 (cyclin-dependent kinase-like 5) deficiency disorder is a rare genetic condition that is caused by mutations in the CDKL5 gene, which is found on the X chromosome. The CDKL5 gene tells the body how to make a protein that is needed for typical brain development.

Most people affected by a CDKL5 disorder have seizures beginning in the first months of life. Problems with development often lead to cognitive and physical delays, sleeping issues, scoliosis (curvature of the spine), visual challenges and gastrointestinal difficulties.

 

What Is Duplication 15q Syndrome (Dup15q)?

Duplication 15q syndrome (Dup15q) is a neurodevelopmental disorder caused by the partial duplication of chromosome 15, causing a variety of symptoms, including seizures, autism, cognitive and physical delays, and low muscle tone.

There is a wide range of severity in the challenges associated with Dup15q, and two people with the syndrome may have very different abilities and skills.

FAQ – Frequently Asked Questions

What is the ARCADE study?

  • ARCADE is a Phase 2 open-label pilot study. The primary goal of the ARCADE study is to assess the effect of OV935 on the frequency of participants’ seizures. Other key study objectives include examining the safety and tolerability of OV935 and how it works within the body.

What is the investigational medication?

  • The investigational medication in the ARCADE study is OV935. To learn more about OV935, click here.

What does it cost to participate in the ARCADE study?

  • There is no charge for participants to take part in the clinical study. The investigational medicine and study-required care plus travel-related expenses and childcare will be covered by the study sponsor, Ovid Therapeutics.

How can I learn more about participating in the ARCADE study?

  • You can learn more about study eligibility by answering this short prescreener. If your child or the individual you care for qualifies for referral to a study medical center conducting ARCADE, other study requirements will be explained to you by the study team.

How will privacy be protected during the study?

  • The study sponsor, Ovid Therapeutics, respects the privacy of families and those who participate in its clinical studies and the personal healthcare data generated throughout the study. In accordance with HIPAA regulations, only the medical personnel associated with the study will have access to any personally identifiable medical information.

What if we begin to have doubts about participating?

  • The study team is available to answer all your questions. Please remember that the healthcare professionals on your study team are a resource for you. Participating in ARCADE is completely voluntary, and your child or the individual you care for may withdraw from the study at any time and without consequences.

Who do I contact with questions?

Helpful Resources

You can learn more about ARCADE by downloading materials. Additional materials may be available in the future.

The following organizations are dedicated to CDD and Dup15q research and support for patients and families:

Information about clinical research studies and what it means to be a study participant can be found on the following websites:

Includes important information to consider before joining a clinical trial, as well as informational videos on how to be a good clinical trial participant.

A comprehensive list of all clinical studies currently underway in the United States.

Information for people who are interested in joining a clinical trial.

Clinical Research

A clinical research study is a scientific test that helps determine if and how a potential medicine or treatment may work.Clinical research studies, like the ARCADE study, are conducted in four different phases that involve increasing numbers of study doctors and participants and longer periods of time. The U.S. Food and Drug Administration monitors clinical research studies, and independent ethics committees review research studies to safeguard the rights and welfare of research participants.

Participating in a study is voluntary, and people agree to participate in studies for many reasons. These can include the chance to help others who may be or become affected by certain conditions, to give back to the scientific community, to play an active role in their health, and to gain access to new potential medicines.

Participating in a clinical study includes potential risks and benefits, and it is not possible to know in advance who may or may not experience them. Your study team will explain the possible risks and benefits to you and your child, or the individual you care for, and you can ask questions at any time during the study.

Deciding to volunteer in a clinical research study is an important choice. If your child, or the individual you care for, qualifies to participate in ARCADE, your study team will ensure that both of you understand the study and its possible risks and benefits. Participants can decide to withdraw from the ARCADE study at any time.