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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.
Star Trial Criteria
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).
A clinical study is enrolling patients who have pseudobulbar affect, a neurologic condition characterized by episodes of uncontrollable laughing and/or crying.
A total of 270 adults diagnosed 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 a targeted investigational treatment known as Zenvia™ or AVP-923. This study is known as the STAR trial (Safety, Tolerability and Efficacy Results of AVP-923 in PBA).
STAR TRIAL MAIN INCLUSION/EXCLUSION CRITERIA- The patient is 18-80 years of age.
- The patient has a clinical diagnosis of pseudobulbar affect.
- Patient exhibits uncontrollable episodes of laughing and/or crying.
- The patient has a confirmed diagnosis of amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).
- If female, must not be pregnant, breastfeeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study.
- If female, must have been practicing an established method of birth control for at least the prior month, or be surgically sterile or post-menopausal.
- Patient must be willing to not take any prohibited medications during participation in the study.
