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

Fragile X Syndrome Clinical Trial

Official title:

An Open Label Exploratory Study to Investigate the Safety and Effects of NPL-2009 ( 50 mg - 150 mg Single Dose) on Prepulse Inhibition Tests and Continuous Performance Tasks, in Adults With Fragile X Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637221
• Other study ID #: NPL-2009-2-FEN-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 3, 2008
• Last updated: April 26, 2012
• Start date: March 2008
• Est. completion date: April 2008

Study information

• Verified date: April 2012
• Source: Neuropharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fragile X Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Centre	Chicago	Illinois
United States	MIND Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Neuropharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for the study is that of safety and subjects will be assessed post-dose at at least hourly intervals for any signs of Adverse Events - up to allowing discharge from the unit at 6 hours post-dose		7 Days	Yes
Secondary	Tolerability		7 days	No