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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuropharm
ClinicalTrials.gov Identifier:
NCT00637221
First received: March 3, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Fragile X Syndrome
Drug: NPL-2009
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Neuropharm:

Primary Outcome Measures:
  • 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 [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NPL-2009
    Single doses of either 50mg, 100 mg or 150 mg NPL-2009
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637221

Locations
United States, California
MIND Institute
Sacramento, California, United States, 95817
United States, Illinois
Rush University Medical Centre
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Neuropharm
Investigators
Study Director: Mike Snape, PhD Neuropharm Ltd
  More Information

No publications provided

Responsible Party: Neuropharm
ClinicalTrials.gov Identifier: NCT00637221     History of Changes
Other Study ID Numbers: NPL-2009-2-FEN-001
Study First Received: March 3, 2008
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuropharm:
Safety
Tolerability

Additional relevant MeSH terms:
Mental Retardation, X-Linked
Fragile X Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on July 28, 2014