excessive sleepiness MedDRA version: 9.1 Level: LLT Classification code 10015595 Term: Excessive daytime sleepiness
Conditions
Interventions
Product Name: VSF-173
Product Code: VSF-173
Pharmaceutical Form: Tablet
Current Sponsor code: VSF-173
Other descriptive name: 2-[2-methylimidazol-1-ylmethyl] pyridine fumarate
Concentration unit: mg m
Sponsors
Vanda Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General 1. ability and acceptance to provide written informed consent; 2. male or female = 18 and = 40 years old; 3. Body Mass Index [BMI] of > 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sleep History 1. history or evidence of excessive daytime sleepiness as determined by a score of more than 10 in the Epworth Sleepiness Scale ; 2. history or evidence of sleep apnea as determined by a high-risk score in any two of the three categories in the Berlin Questionnaire ; 3. evidence of insomnia as determined by a score of more than 10 in the Athens Insomnia Scale-5 (AIS-5) ; 4. history or evidence of any other sleep disorder; 5. evidence of daytime nap (per actiwatch) of more than two hrs for the 5 days prior to Day 1. Medical History 6. history of hypotension or syncope; 7. history of drug induced allergy; 8. history of more than 3 episodes of hives within the last 12 months; 9. history or current evidence of cardiovascular, hepatic, hematopoietic, endocrine, renal, gastrointestinal or metabolic dysfunction; 10. known history of leukopenia or thrombocytopenia; 11. a systolic blood pressure of less than 95 mmHg or greater than 140 mmHg; or a diastolic blood pressure of less than 60 mmHg or greater than 90 mmHg after lying supine for 10 minutes and standing for 3 minutes, or a heart rate less than 50 bpm or more than 90 bpm; 12. loss or withdrawal of one pint (approximately 450 mL) or more of blood within one month before the screening visit; 13. a positive hepatitis B surface antigen (HBsAg) test result; 14. a positive hepatitis C antibody or HIV serology test result; 15. pregnancy or lactation; 16. active disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of drugs; 17. a history or a current diagnosis of cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms); 18. psychiatric or neurological disorders requiring chronic medication (including but not limited to psychotropic medication) or liable to prejudice subject compliance; 19. unstable, severe, or clinically significant cardiovascular disease (e.g., myocardial infarction in the past 5 years, or unstable angina, cardiac failure [New York Heart Association, Class II or more], or second or third degree atrioventricular block); 20. past history or current diagnosis of seizure disorder; 21. a significant physical illness that requires hospitalization in the 4-week period preceding and during the screening visit; 22. a known exaggerated pharmacological sensitivity or hypersensitivity to NDD094/VSF-173 or fumarate salts; 23. any other medical condition, not previously mentioned, that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk; 24. subjects who have participated in a previous NDD094/VSF-173 trials; Medication Use 25. any subjects who smoke cigarettes or has a urine cotinine greater than 1.2 µmol/L (200ng/mL); 26. consume more than 450 mg of caffeine per day for the 2 weeks preceding Day 1 or consume any caffeine after lunch during screening; The Investigator should be guided by Appendix 12.7 (Caffeine Content of Selected Drugs and Food) to calculate the average subject’s caffeine consumption per day. 27. consume more than 40 g/day of alcohol within the 3 weeks preceding the screening visit; 28. history of drug abuse, known drug addiction or positive test for drug abuse at screening or on Day 1; 29. use of any prescription medications (except for menopausal-related hormone replaceme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of VSF-173 compared to placebo in healthy subjects with induced excessive sleepiness (ES) as assessed by the Maintenance of Wakefulness test (MWT). ;Secondary Objective: (1) to assess the effect of VSF-173 compared to placebo on subjective sleepiness as measured by Karolinska Sleepiness Scale (KSS) in healthy subjects with induced ES; (2) to assess the effect of VSF-173 compared to placebo on objective performance as measured by Psychomotor Vigilance Task (PVT) in healthy subjects with induced ES; (3) to assess the effect of VSF-173 compared to placebo on mood as measured by a visual analog scale (VAS) in healthy subjects with induced ES; (4) to assess the safety and tolerability of VSF-173 in healthy subjects.;Primary end point(s): The primary endpoint will be defined as the average of the 6 post-baseline MWT tests performed every 2 hours during the study. | — |
Countries
France
Outcome results
None listed