Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Exclusion Criteria

• •Subjects with a history of intolerance to baclofen, roflumilast, or memantine will be excluded.
• •Subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or CNS neurological disease unrelated to FXS.
• •Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months
• •Auditory or visual impairments that cannot be corrected based on visual and auditory screener benchmarks.
• •Moderate to severe renal or hepatic impairment and determined by a study physician incorporating data from exam, medical history and laboratory value evaluation among other data points.
• •Use of barbiturates, benzodiazepines, antiepileptics, or other GABAergic or glutamatergic modulators
• •Current use of: Amifampridine, Butalbital, Codeine, Doxylamine, Ethanol, Hydrocodone, Isocarboxazid, Kava, Metoclopramide, Midazolam, Oxybate, Phenelzine, Promethazine, Thalidomide, Tranylcypromine, Trimethobenzamide, Erythromycin, Ketoconazole, Fluvoxamine, Enoxacin, and Cimetidine.
• •Those taking other psychiatric medications must be on stable doses for 4 weeks before the baseline visit.
• •Pregnancy or breast-feeding. For female subjects of child bearing potential, a urine pregnancy test will be performed.
• •Potential subjects with a creatinine clearance \< 50 mL/min will be excluded.
• •Identified medical issues, inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.