Poster 97 Rehabilitation of a Stroke Patient with Charles Bonnet Syndrome: A Case Report

Abstract

were excluded if they had a history of malignancy (except for local skin cancer or in situ cervical carcinoma) or inflammatory granuloma, or if they had a life expectancy <12 months. Interventions: After obtaining an informed consent, the provider withdrew residual 2 mg/mL baclofen from the subject's implanted pump and replaced it with 3 mg/mL of Gablofen Ò . Dose adjustments were not allowed for the first 10 days, after which the dose was adjusted up to 2 mg/day. Main Outcome Measures: Incidence of catheter-tip granulomas as confirmed by Magnetic Resonance Imaging (MRI) with or without contrast or a CT scan (when MRI was contraindicated), as well as other treatment-emergent adverse events (TEAEs) reported in the study population. Results or Clinical Course: Of the 153 enrolled subjects (age range 4 -69 years old), 108 (70.6%) completed their 9-month follow-up at the time of this safety analysis. A total of 50 serious adverse events (SAEs) were reported in 29 subjects (19%), and 4 events in 3 subjects (2.0%) were reported to be related to the study medication. None of the reported SAEs were considered unexpected based on the safety profile of intrathecal baclofen. Among the 63.4% of study subjects who experienced at least one TEAE, 8.5% of adverse events were considered treatment-related by the investigator. Overall, seven subjects presented with clinical signs and symptoms suggestive of a granuloma. Results from MRI in 6 subjects and CT scan in one subject confirmed absence of any catheter-tip granulomas in all seven subjects. Discussion: Not applicable Conclusion: No confirmed masses or catheter tip granulomas were seen in subjects who were administered 3 mg/mL baclofen via intrathecal pump during the 9-month duration. The 3 mg/mL concentration of baclofen appears to be safe and well-tolerated in the study population.Poster 97