The PIONEER-KD clinical research study is for adults who have Spinal and Bulbar Muscular Atrophy (SBMA), also known as Kennedy's Disease. This study aims to investigate if the study medication, NIDO-361, is safe, well-tolerated, and effective when taken by patients with Kennedy's Disease.
Patients suffering from Kennedy's Disease may be able to join the study if they meet the following requirements:
Male; 18-70 years of age
Confirmed genetic diagnosis of SBMA
Must have the ability to walk independently or with a walking aid for 6 minutes
Other study requirements will apply.
Participation in the PIONEER-KD study lasts approximately 13.5 months. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study medication, NIDO-361, is designed to correct the function of the androgen receptor and help restore muscle strength and endurance in adults living with Kennedy's Disease. The PIONEER-KD study will investigate the safety and efficacy of NIDO-361 as a potential treatment.
Participants will be chosen at random to receive either NIDO-361 or placebo. A single dose of the assigned treatment will be taken orally every day, in tablet form, for a duration of 12 months.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the PIONEER-KD study.
SBMA, also known as Kennedy's Disease, is a genetic neuromuscular disorder that occurs in men usually between 20-50 years old. Kennedy's Disease primarily affects your neuromuscular system causing loss of strength and movement, and affects reproductive tissues causing reduced fertility.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.