bjects from 33 sites in the United States were randomized into the six-week trial at a ratio of 2:1, active to placebo. The population was composed of patients with a clinically definitive diagnosis of Multiple Sclerosis with evidence of cognitive impairment at intake. Inclusion criteria mandated that all enrolled patients demonstrate a pattern of impairment on the Symbol Digit Modalities test (a measure of processing speed), the California Verbal Learning Test (a measure of verbal learning and memory) and the Paced Auditory Serial Addition Test (a measure of working memory). Patients were screened for depression at intake, and those with evidence of an untreated Major Depressive Disorder were excluded. Dose was titrated over 14 days, and patients remained on a therapeutic dose for another 14 days. Patients were administered a standardized cognitive assessment battery (MACFIMS; Minimal Assessment of Cognitive Function in Multiple Sclerosis) at screening and stable peak dose, and a subset of this battery was administered on intervening study days and at a follow up visit.
The company said it was ready to initiate a pivotal study that establishes the endpoints for Phase III MS trials. Appropriate measures have been validated for use in the U.S. and Europe. It is anticipated that C105 can be submitted for NDA in early 2011 in this most direct path to approval. Additional plans for approval in other, larger markets, including Learning Disorders and Mild Cognitive Impairment, have also been developed.
The levo enantiomer of amphetamine sulfate (l-amphetamine) is similar to dextro enantiomer (d-amphetamine), a widely used central nervous system (CNS) stimulant (known commercially as Dexedrine). Both C105 and d-amphetamine have similar activating properties for norepinephrine; however, C10
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|SOURCE Cognition Pharmaceuticals LLC|
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