The study will last approximately two years and include nine (9) clinic visits.
The investigational NPI-001 oral tablets are being studied to determine their potential to slow vision loss caused by RP associated with Usher Syndrome. This trial is not designed to treat or assess hearing loss associated with Usher Syndrome.
Yes. Taking part in this study is entirely voluntary. Your decision whether or not to participate will not affect the medical care you currently receive or may receive in the future. If you qualify and choose to join the study, you may leave the study at any time and for any reason.
No. The study sponsor will provide all study-related tests and procedures at no cost to you. However, tests, procedures or treatments that are considered routine care for your eye condition and are not part of the study may be billed to you or your insurance.
Your privacy is important. Personal and medical information collected during the study will be handled in accordance with applicable privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Before you join the study, the research team will explain how your information will be used, who may have access to it, and the measures in place to help protect your privacy.
Yes. This study is registered on ClinicalTrials.gov, a public database of clinical studies maintained by the U.S. National Library of Medicine. You can learn more about the study, including eligibility criteria and study locations, by visiting: https://clinicaltrials.gov/study/NCT07710196.
The U.S. Food and Drug Administration (FDA) has granted NPI-001 Breakthrough Therapy, Fast Track and Orphan Drug designations for the treatment of RP associated with Usher Syndrome. These designations are intended to help support the development and review of potential treatments for serious or rare diseases.
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