open label study investigating safety and efficacy of npl2009 50 mg - 150 mg on prepulse inhibition tests and continuous performance tasks, adults with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this is an open label exploratory study to investigate the safety and effects of a single dose of npl-2009(50 mg - 150 mg) on prepulse inhibition (ppi) tests and continuous performance tasks (cpt) in adults with fragile x syndrome


Eligibility criteria:
inclusion criteria: * male or female patients, 18 to 45 years of age. * diagnosis of fragile x syndrome. * females must demonstrate a negative pregnancy test at screening. * females of child-bearing potential must be using a medically accepted means of contraception or must remain abstinent for the duration of the study. * each legally authorised representative (lar, usually parent or caregiver) must have a level of understanding sufficient to provide written informed consent to all required study tests and procedures. * each patient must consent/assent (depending on center-specific procedures) to all required study tests and procedures. * permitted concomitant medications must be stable for at least 6 weeks prior to enrollment. the following concomitant medications are permitted: psychostimulants, ssris, atypical antipsychotics, anticonvulsants which do not have liver inducing effects, clonidine. * each patient must be able to swallow the capsules (2, 3 or 4) to be provided in the study. exclusion criteria: * current treatment with anticonvulsants known to induce liver enzymes e.g. depakote * current treatment with n-methyl-d-aspartate (nmda) antagonists * current treatment with tricyclic antidepressants * current treatment with typical antipsychotics * current treatment with lithium * patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behavioural therapy within 6 weeks prior to enrolment. * history of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication. * history of, or current cerebrovascular disease or brain trauma. * history of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism. * history of, or current malignancy. * presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the investigator. * current major depressive disorder (patients must be free of the disorder for 3 months prior to enrolment). * judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the investigator. * tourette's disorder. * female patients who are either pregnant or nursing. * current drug abuse or dependence disorder or dependency in the 3 months prior to enrolment. * clinically significant abnormalities in safety laboratory tests, vital signs or ekg, as measured at screening * patients with significant hearing and/or visual impairments that may affect their ability to complete the test procedures * enrollment in another clinical trial within the previous 30 days

Keywords: safety tolerability