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

NCT ID: NCT00637221

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-04-30

Brief 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

Conditions

Fragile X Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

NPL-2009

Single doses of either 50mg, 100 mg or 150 mg NPL-2009

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuropharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Snape, PhD

Role: STUDY_DIRECTOR

Neuropharm Ltd

Locations

MIND Institute

Sacramento, California, United States

Rush University Medical Centre

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NPL-2009-2-FEN-001

Identifier Type: -

Identifier Source: org_study_id