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 with CDD or Dup15q. As with any clinical research study, all potential risks and benefits cannot be known in advance. Your child will be closely monitored throughout the study so potential risks can be anticipated and addressed.
The ARCADE study will enroll approximately 30 participants between the ages of 2 and 17, including 15 children with CDD and 15 children 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 qualifies for ARCADE, participation will last approximately 22 weeks and include eight visits to the study medical center. During these visits to the study medical center, you and your child 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 your child’s health. At the end of ARCADE, you and your child 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 will also cover the cost of travel, lodging, childcare and other study-related costs. Please talk to your study team for details.
CDD and Dup15q are rare and complex diseases, and current treatment options help manage specific symptoms. Many children with CDD or Dup15q receive multiple services, including physical, occupational and speech therapies that are beneficial in enhancing or maintaining quality of life. Children with CDD and Dup15q 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 with CDD and Dup15q.
By participating in ARCADE, your child may help medical researchers learn more about CDD or Dup15q and potential future treatment options.
To participate in the ARCADE study, your child must meet the following criteria:
ARCADE also has other requirements that help ensure the safety of all participants. If your child qualifies to participate in the study, these additional conditions will be reviewed with you by the team at your study medical center.
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.
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.
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 parents and children who are interested in joining a clinical trial.
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, 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 qualifies to participate in ARCADE, your study team will ensure that both of you understand the study and its possible risks and benefits. You or your child can decide to withdraw from the ARCADE study at any time.
