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BHV-4157 for Ataxia
Study Summary
This trial is to test the efficacy of BHV-4157 in treating cerebellar ataxia in adults. Patients will be required to visit UCLA five times over the course of the 12 weeks--once for screening, once for baseline testing, and then once every four weeks. There is also the option to extend the trial for an additional 36 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't taken tricyclic antidepressants or MAO inhibitors in the last 30 days.I have not taken memantine in the last 30 days.I use NSAIDs regularly and take proton pump inhibitors unless advised not to by a doctor.I am between 18 and 75 years old.I have a specific type of hereditary ataxia or non-genetic pure cerebellar ataxia and have been taking Riluzole for over 8 weeks.I am willing to undergo genetic testing if I haven't already.- You can walk 8 meters without help, but can use canes or other devices if needed.
- Your medical history, physical exam, lab test results, and ECG show that you are stable.
- You have completed at least 6 years of education.
- You have good hearing, vision, and language skills to communicate with study personnel.
- You understand and agree to follow the study's medication and procedure instructions, attend appointments, and report any side effects or other medications you take.
- If you are a woman who can become pregnant, you and your partner must use two forms of birth control during the study to avoid pregnancy. Hormonal contraceptives alone are not enough. One method must be a barrier method like a condom with spermicide, an IUD, or cervical cap. The second method can be another barrier method or oral contraceptives.Your liver test results are not normal.You have kidney problems detected during the screening.You have had blood problems within the last 3 months.I have been treated with riluzole for at least 8 weeks.I have not taken chlorzoxazone in the last 30 days.I haven't taken aminopyridine in the last 30 days.My balance and walking difficulties are moderate to severe.My memory and thinking skills test score is below 24.Your SARA total score is higher than 30 points during screening.I haven't started and won't start physical or occupational therapy in the next 3 months.People with weakened immune systems.I am between 18 and 75 years old.I have liver disease or a history of liver reactions to medications.I was diagnosed with cancer within the last 5 years.You have been diagnosed with schizophrenia or bipolar disorder, or have been treated for these conditions in the past.I have not had a major depressive episode in the last 6 months.I have had neurosyphilis in the past.You have struggled with drug or alcohol abuse in the past year.I have hereditary ataxia (SCA1, SCA2, SCA3, or SCA6) and have been on Riluzole for over 8 weeks.I am currently using approved Alzheimer's treatments.I have a type of ataxia that affects my balance and coordination, not caused by genetics.I have been diagnosed with multiple system atrophy of the cerebellar type (MSA-C).I have SCA and have been on Riluzole for over 8 weeks.I have had a stroke in the past.I have had serious stomach or intestine problems.I can follow the study's treatment plan, attend all appointments, and communicate openly about side effects and medications.I am using effective birth control during and up to 30 days after the study.Women who could become pregnant must have a negative pregnancy test before the study and before taking any medication.My ataxia symptoms are not caused by another medical condition.I haven't had any major heart, lung, stomach, or liver problems in the last month.I have a long-term lung condition.My blood pressure is not controlled with medication.My heart's electrical activity is irregular or the time it takes my heart to recharge between beats is longer than normal.I couldn't tolerate riluzole treatment.I have not taken riluzole in the last 30 days and will not during the study.You have used medical marijuana within the 30 days before the study starts.I can walk 8 meters by myself.I haven't started or changed any anxiety or sleep medication in the last 30 days.People who fit the specific group or condition the study is looking to test or treat.You or your legal representative must sign a form that explains the study and your participation before any procedures can begin.My heart condition is in its final stage.Your HbA1C level is higher than 7.5% in the last 3 months.You have severe muscle stiffness or uncontrollable muscle movements that make it difficult to accurately measure the severity of your ataxia.You have low levels of vitamin B12 or folate in your body.
- Group 1: Open Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Am I eligible to participate in this research?
"The ideal candidates for this clinical trial are those suffering from spinocerebellar ataxias who fall between the ages of 18 and 75. So far, around 24 people have met the requirements."
Does this research include geriatric patients in the test group?
"To be eligible for this study, patients must fall between the ages of 18-75. There are 19 similar studies recruiting patients that are underaged and 33 trials for seniors."
Are people currently being recruited for this experiment?
"According to the most recent update on clinicaltrials.gov, this particular trial is not recruiting patients at the moment. The original posting was on December 15th, 2017 however the last update was on June 10th, 2022. There are other 47 trials that are currently looking for participants though."
What are the deleterious effects of BHV-4157?
"BHV-4157 was given a safety score of 3. This is based on the fact that it is currently in Phase 3 trials, meaning that there is both efficacy and safety data available."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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