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
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
|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 October 16, 2014
Fragile X Syndrome
Mental Retardation, X-Linked
Nervous System Diseases
Sex Chromosome Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System