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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuropharm

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