Biohaven Troriluzole Study in the US

[wobblybee]

🙂 Although this Study is US based, it’s an interesting read.

Spinocerebellar Ataxia Study

Have you or a loved one been diagnosed with Spinocerebellar Ataxia (SCA)? If so, you could help us learn about a new investigational medication being tested in people with SCA.

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Biohaven Pharmaceuticals is studying an investigational medication called troriluzole to see if it can slow down and improve symptoms in people with SCA. If you are at least 18 years of age you may qualify.

Contact one of our research sites and find out if you qualify for this clinical research study. The investigational drug, plus all study-related

assessments, will be provided at no cost to you. Health insurance is not required to take part in this study and compensation for participation may also be provided. Learn more about why you should participate.

See If You Qualify

Visit the Clara Health websites below for more information:

Visit here if you suffer from hereditary ataxia

Visit here if your loved one suffers from hereditary ataxia

Purpose of the SCA Study

This is a research study, or clinical trial, to test a new investigational medication. An investigational medication is one that is not approved by the United States Food and Drug Administration (FDA). The purpose of this research study is to determine if troriluzole can slow down and improve symptoms in people with SCA.

About 300 subjects will be screened.

About 230 study participants will enter into the treatment phase of the study.

This study will include study participants primarily with disease-types SCA1 and SCA2, but may also include SCA3, SCA6, SCA7, SCA8 and SCA10 (enrollment cap met for SCA 3,6,7,8, and 10).

SCA Study Details

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Participants are randomized one-to-one to receive a placebo (an inactive tablet that does not contain study medication) or troriluzole (investigational medication for slowing down and improving the symptoms of ataxia) and take two pills once daily.

If you qualify, your participation will last approximately 106 weeks and will include approximately 17 study visits to the study center near you.

The first 48 weeks of the treatment phase is double blind, meaning that neither you nor your study doctor will know if you are receiving placebo or the Investigational Product. You may then qualify for 48 weeks of open label medication (no placebo is given during this time; study participants are only assigned to active investigational medication).

Cheerful Seniors

About Spinocerebellar Ataxia (SCA)

See if You Qualify

SCA is an inherited form of ataxia, a rare and progressive neurological disease that develops due to damage to the cerebellum, the part of the brain responsible for coordinating movement.

Ataxia affects nearly 150,000 people living in the U.S. of which an estimated 3,200–18,000 have SCA.

Symptoms of SCA may include lack of coordination, trouble with balance, difficulty swallowing, slurred speech and/or deterioration of fine motor skills.

The most common types of SCA are SCA1, SCA2, SCA3, SCA6 and SCA7 which are caused by specific genetic defects.

People are typically diagnosed in their mid-30s but SCA can affect individuals of any gender, age, or race.

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There is no cure or FDA-approved treatment for SCA. Current treatment approaches focus on symptom management to improve quality of life.

[Litty]

Thank you so much. Their drug sounds very interesting. Shame in America but I have emailed them (I have SCA1), so keep you posted. Thanks x

[Litty in reply to Litty]

Good reply but not feasible -

Hi Lit,

This study does accept international applicants - however, it also requires each participant be able to attend every study visit in person. There are 17 in-person visits total over a 24 month period. Is this feasible for you?

Thank you,

Clara Team

[wobblybee in reply to Litty]

😏 Yes, I expect any trial in this country would be inundated. This started off as Trigriluzole, and was ‘tweaked’ to Troriluzole. You can follow the progress on clinicaltrials.gov..I’ll look for the trial number.