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):
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
Fragile X Syndrome
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
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:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637221
|Sacramento, California, United States, 95817 |
|Rush University Medical Centre
|Chicago, Illinois, United States, 60612 |
||Mike Snape, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 3, 2008
||April 26, 2012
||United States: Food and Drug Administration
Keywords provided by Neuropharm:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Mental Retardation, X-Linked
Fragile X Syndrome
Nervous System Diseases
Sex Chromosome Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System