Interested in learning more about PBA and our clinical trial? Please take a moment to fill out our interest form so that we may contact you.
PBA is a condition characterized by episodes of uncontrollable laughing and/or crying that may be inappropriate, unrelated to the situation at hand, or not expressing the person's mood. The condition is known by other terms, including emotional lability, emotional incontinence, and pathological laughing and crying.
If you or someone you know experiences episodes of uncontrollable laughing and/or crying, you may be eligible to participate in a clinical study now underway to find a treatment for pseudobulbar affect (PBA).
Trial FAQs
Frequently Asked Questions about Pseudobulbar Affect (PBA) Research Studies
Click on questions and answers will appear.
What research trials are available?
How will I know if I'm eligible?
What are my rights?
Will I get a placebo (sugar pill)?
How many study visits will I make?
What does the drug consist of?
What were the side effects of Zenvia™ in prior studies?
Will participation in the STAR trial cost me anything?
Who should I contact?
How can I be sure my privacy is protected if I participate in the STAR trial?
Who is funding the STAR trial?
What research trials are available?
top
How will I know if I'm eligible?
top
What are my rights?
top
Will I get a placebo (sugar pill)?
top
How many study visits will I make?
top
What does the study drug consist of?
top
What were the side effects of Zenvia™ in prior studies?
top
Will participation in the STAR trial cost me anything?
top
Who should I contact?
top
How can I be sure my privacy is protected if I participate in a STAR trial?
top
Who is funding the STAR trial?
top
Click on questions and answers will appear.
What research trials are available?
How will I know if I'm eligible?
What are my rights?
Will I get a placebo (sugar pill)?
How many study visits will I make?
What does the drug consist of?
What were the side effects of Zenvia™ in prior studies?
Will participation in the STAR trial cost me anything?
Who should I contact?
How can I be sure my privacy is protected if I participate in the STAR trial?
Who is funding the STAR trial?
What research trials are available?
- The STAR trial is enrolling patients who have pseudobulbar affect (PBA), a condition characterized by episodes of uncontrollable laughing and/or crying associated with various neurologic disorders.
- A total of 270 adults with multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS) exhibiting signs and symptoms of pseudobulbar affect are being sought for approximately 30 U.S. study sites testing the efficacy and safety of an investigational targeted treatment known as Zenvia™ or AVP-923.
top
How will I know if I'm eligible?
- If you are diagnosed with multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS) and also have PBA, you may be eligible.
- If you have experienced uncontrollable laughing and/or crying but have not yet been diagnosed with pseudobulbar affect, you may be eligible but need to visit a study site for assessment of your symptoms.
- A number of inclusion and exclusion criteria will determine your eligibility (see trial Criteria).
- Your eligibility will be determined by the clinical study site conducting the trial.
top
What are my rights?
- You have the right to informed consent. Informed consent is a process that ensures you understand all aspects of the clinical study. Informed consent also is a document derived directly from the specific information about the clinical trial and how it may affect you. It is a form to read and sign, indicating your willingness to participate in the study.
- The form contains potential risks and benefits of participating in the study.
- The form also will highlight details of the study, including required tests and examinations.
- Participation in this, or any, clinical trial is voluntary. You have the right to withdraw from the study at any time, and this decision will not have any impact in your medical treatment.
- You have the right to know about any significant findings that may influence you and your health during the remainder of the study.
top
Will I get a placebo (sugar pill)?
- You will have 33% chance of getting placebo (sugar pill). The inclusion of placebo is necessary to compare the investigational drug and evaluate the results of the clinical study.
top
How many study visits will I make?
- The study lasts up to 3 months with an optional 3-month extension phase. In a three-month timeframe, you will need to come to the clinic a total of six times.
- You will be required to keep a patient diary during the duration of the trial.
- The shortest clinic visits last about 30-45 minutes. The longest clinic visits are one to two hours.
top
What does the study drug consist of?
- Zenvia™ is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine.
top
What were the side effects of Zenvia™ in prior studies?
- Adverse events associated with Zenvia™ were generally mild to moderate in severity and included dizziness, nausea, sleepiness, and headache.
top
Will participation in the STAR trial cost me anything?
- No, there is no cost to participate.
top
Who should I contact?
- Please complete our STAR trial Interest form.
top
How can I be sure my privacy is protected if I participate in a STAR trial?
- The initial pre-screener and the doctor and nurses at the study site will know you are participating in the study. Names or other personally identifiable information of study participants will not be shared with the STAR trial sponsor Avanir Pharmaceuticals. Processes and procedures are in place to protect your privacy. Your name would be provided to affiliated third parties only with your written permission.
top
Who is funding the STAR trial?
- The trial is sponsored by Avanir Pharmaceuticals. Avanir, based in Aliso Viejo, California, is a drug discovery and development company focused on novel treatments for central nervous system disorders.
top
