Clinical Trials Resource Center

Mental Disability

August 2, 2010

Seaside Therapeutics released positive results from a phase II trial of STX209 for the treatment of Fragile X syndrome. This randomized, double-blind, placebo-controlled, two-period crossover study enrolled 63 subjects, ranging in age from six to 40 years old. Dosing was conducted as a flexible titration, every three days, to the optimal titrated dose (OTD). The starting dose was 1 mg twice a day and was gradually increased up to 10 mg twice a day for subjects <11 years and up to 10 mg three times a day for subjects ≥12 years. OTD was continued for the remainder of the four-week treatment period. Data are from 54 evaluable subjects. While improvement was noted for the primary endpoint, the Irritability subscale of the Aberrant Behavior Checklist, statistical significance was not reached versus placebo. STX209 consistently showed a positive trend for all global measures, including investigators assessments of Clinical Global Impressions of Improvement (p≡0.18) and Severity (p<0.10) and investigator (p<0.10) and caregiver treatment preference (p<0.10). STX209 was well tolerated and there were no metabolic side effects.

August 28, 2006

Neuron reported positive pharmacokinetic results from a phase IIa trial of Glypromate for the prevention of cognitive decline following cardiac surgery. This trial enrolled 33 cardiac surgery subjects, 12 of whom received Glypromate at 3.0 mg/kg/hr, 11 of whom received it at 1.0 mg/kg/hr and 10 subjects received placebo. Pharmacokinetic results revealed a linear dose/exposure relationship; subjects infused at the lower dose achieved blood levels of Glypromate of 960 ng/mL and those infused at the higher dose had a maximal level of 3,508 ng/mL. At both doses Glypromate displayed an elimination half-life of 2 to 3 minutes. Neuren expected to initiate phase III trials before the end of 2006.

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