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A Study to Learn More About Friedrich's Ataxia in People Living in the Gulf Cooperation Council (GCC) Region of the World

Ensayo de BIOGEN INC. en Friedreich's Ataxia (del registro, en inglés).

Fase

no aplica

Estado

Aún sin reclutar

Participantes

40

previstos

Fin del objetivo primario

ene 2029

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en oct 2026.

De principio a fin

1. Empieza el ensayo (oct 2026)
2. Hoy
3. Lectura de resultados ene 2029 (prevista)

Los cambios los anota PivotalWire desde agosto de 2026; lo anterior no lo tenemos. El historial completo, versión a versión, está en ClinicalTrials.gov.

Qué mide

Change From Baseline in Modified Friedreich's Ataxia Rating Scale (mFARS) Score (Baseline up to approximately 24 months) (del registro, en inglés)

Qué se prueba

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn this study, researchers will learn more about a disease called Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. In certain parts of the world, people with FA may not know about the disease or have access to genetic testing to get a diagnosis. To help more people get medical care for FA across the world, researchers need to learn more about any cases that do happen. Participants for this study will come from West Asia, in countries covered by the "Gulf Cooperation Council", also known as the GCC. This will include study sites in Saudi Arabia, Kuwait, Qatar, Oman, Bahrain, and the United Arab Emirates (UAE). The main goal of this study is to learn more about the natural history and participant experience of FA in people living in the GCC region of the world. This will include learning about their experiences, symptoms, and how the disease affects their daily lives over time. To do this, researchers will collect information from participants' medical records and regular healthcare visits. Researchers hope that what they learn from this study will help them understand more about FA in this part of the world so that they can better understand people need for their FA. The main question researchers want to answer in this study is: • What are the experiences of people with FA, and how does the disease affect people over time in the GCC region of the world? Researchers will also learn more about: * About how many cases of FA are happening in this part of the world? * How different do FA cases look like in this part of the world? * What information in the participants' medical records helps show the difference between FA and other kinds of ataxia? This study will be done as follows: * Participants will join the study after signing an informed consent form, also known as an ICF. * During the study, health information from the participants' regular visits to their doctor will be collected about every 6 months. * Information about participants' FA symptoms, medical history, genetic test results, and daily functioning will be collected. * For participants already receiving treatment for FA, information from before they started treatment may also be collected from medical records. * During regular visits, researchers will also collect information about participants' FA symptoms and their ability to do their daily living activities. * Each participant will be in the study for up to about 2 years.

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Ficha completa en ClinicalTrials.gov (NCT07887828), actualizada en oct 2026.