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Repository corticotropin injection (Acthar gel; Mallinckrodt, Staines-upon-Thames, UKI) is being assessed as an investigational treatment for amyotrophic lateral sclerosis (ALS), and 50% of the intended participants in a phase 2b study (NCT03068754) are now enrolled. Participants, age 18 to 75 years, who diagnosed with ALS who had their first symptoms in the previous 2 years will be randomly assigned to receive subcutaneous repository corticotropin or placebo on a 2:1 basis for 36 weeks. The intended enrollment is 210 people. Efficacy will be assessed with the ALS Functional Rating...
The first participant is enrolled in a clinical study of ENT-01(Enterin, Philadelphia, PA), a compound designed to reverse neurologic symptoms associated with Parkinson’s disease dementia (PDD). The aim of the DEMET study, an open-label multi-center trial, is to enroll 30 participants with PDD over a 6-month period. Participants will receive escalating daily doses of ENT-01, followed by a fixed dose for 25 days. ENT-01 is a synthetic derivative of squalamine that is not absorbed into the bloodstream. Synthetic squalamine has been shown to prevent buildup and reduce toxicity of...
In a phase 3 study, perampanel (Fycompa; Eisai, Woodcliff Lake, NJ) used as monotherapy for new-onset or untreated partial-onset seizures (POS) provided seizure freedom for 63% (46/73) of people treated (95% CI: 50.9–74.0). In an open-label descriptive study (NCT03201900), 73 participants, age 12 years or more, were treated with 4 mg/day of perampanel after a 6-week titration period and a 4-week pretreatment phase. Participants’ median baseline seizure frequency before treatment was 2 seizures/12 weeks. Of the patients who had secondarily generalized seizures, 65% (31/48)...
James E. Galvin, MD, MPH
Nabeel Saif BA, MS; George Sadek, BA; Sonia Bellara, MBBS; Hollie Hristov, FNP; and Richard S. Isaacson, MD
Peter McAllister, MD