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Avanir Pharmaceuticals, Inc. Message Board

  • onlyfactsplease onlyfactsplease Jan 17, 2013 11:37 AM Flag

    The PRISM Registry is closed

    Not sure if that's been reported here before but the abstract below says it closed in September of 2012 with 5290 patients (I think the plan had been for 20k). The incidence of PBA based on the CNS-LS is reported by disease and is similar to what has been reported before for their interrim reports. The CNS-LS 13 is overly sensitive for clinically relevant PBA IMO.

    [P03.215] PRISM Registry: A Novel Tool To Estimate the Prevalence of Pseudobulbar Affect Symptoms

    Benjamin Brooks, Charlotte, NC, David Crumpacker, Plano, TX, Jonathan Fellus, Secaucus, NJ, Daniel Kantor, Ponte Vedra Beach, FL, Randall Kaye, Aliso Viejo, CA

    OBJECTIVE: To prospectively estimate the prevalence of pseudobulbar affect (PBA) symptoms across six commonly associated disease states. BACKGROUND: PBA is a neurological disorder of emotional expression, occurring secondary to a variety of neurological conditions and characterized by uncontrollable, inappropriate outbursts of laughing and/or crying. Although US prevalence of PBA is estimated at about 2 million persons, PBA is thought to be under-recognized. Disease registries are powerful tools for obtaining epidemiologic data. DESIGN/METHODS: The PBA Registry Series (PRISM) was established to prospectively estimate the prevalence of PBA symptoms in a clinic sample. Participating centers had Institutional Review Board approval. Investigators were asked to enroll ≥20 patients with Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson's disease (PD), stroke, or traumatic brain injury (TBI); patients were not screened for depression or other psychiatric disorders. Participants (or their caregivers) completed the Center for Neurologic Study–Lability Scale (CNS-LS; validated as corresponding to physician diagnosis of PBA in ALS and MS at CNS-LS thresholds ≥13 and ≥17, respectively) and a scale assessing impact of their neurological condition on quality of life (QOL). Demographics and use of antipsychotic/antidepressant medications were also recorded. RESULTS: The PRISM registry closed in September 2012 with 5290 participants. Of these, 1944(36.7%) had PBA symptoms defined as a CNS-LS score ≥ 13 (29.3%, AD;44.8% ALS; 45.8%, MS; 26.0%, PD; 37.8%, stroke; and 52.4%, TBI). Patients with CNS-LS ≥13 reported a greater impact of their neurologic condition on QOL (6.7 ;0-to-10[11-point-scale]) than patients with CNS-LS

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