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.
Information provided by (Responsible Party):
Neuropharm Identifier:
First received: March 3, 2008
Last updated: April 26, 2012
Last verified: April 2012

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00637221

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
Study Director: Mike Snape, PhD Neuropharm Ltd
  More Information

No publications provided

Responsible Party: Neuropharm 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:

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 processed this record on April 17, 2014