Clinical Trial 46492

Winter Park, FL 32789


  • Narcolepsy study
  • We are looking for Patients With Narcolepsy With or Without Cataplexy 

  • 3. Is the subject between the ages of 18 and 65? y/n n=exclusion


    4. Is the BMI ≥18 and ≤40 kg/m2? Y/N N=exclusion


    4. Do you have a diagnosis of narcolepsy with cataplexy (loss of muscle tone)? y/n n=exclusion


    5. Do you agree to discontinue all the medications that you are CURRENTLY taking for narcolepsy?


    6. During the study and 90 days after the last dose, do you agree to use an appropriate method of contraception? Y/N N=exclusion


    Any subject who meets any of the following criteria will NOT qualify for entry into the study

    8. Have you participated in another investigational study within 60 days? Y/N Y=exclusion


    9. Are you an employee or a family member of an employee of this site? Y/N Y=exclusion


    10. Do you have any History of cancer (different than a carcinoma in situ that has been resolved or a basal cell skin cancer) ? Y/N Y=exclusion


    11. Do you have any food, drug, latex allergy, had any anaphylactic reaction or intolerance to any drug or food?


    12. If female, are you pregnant or lactating?


    13. Have you been diagnosed recently with hepatitis B or C or HIV? Y/N y=exclusion


    14. Have you had any major surgery or donated blood in the last 4 weeks? Y/N y=exclusion


    15. Is the subject taking any of the prohibited medications and is unable to refrain from them? 


    16. Have you attempted suicide in the last year? Y/N y= exclusion


    17. Have you experienced epilepsy or seizure in the past? (more than 1 time) Y/N y=exclusion


    18. Do you have any psychiatric disorder? (bipolar disorder or schizophrenia)


    19. Do you have any history of cerebral ischemia, ischemia, intracranial aneurysm or malformation?


    20. Do you have history of coronary artery disease, myocardial infarction, angina, arrhythmia or heart failure?


    21. Within 6 months, have you had a gastrointestinal disease? (malabsorption, reflux, peptic ulcer, esophagitis, frequent heartburn or surgical intervention? Y/N y=exclusion


    22. Do you take fluoxetine or more than 300mg or venlafaxine per day? Y/N y=exclusion


    23. Do you have Obstructive Sleep Apnea, Restless legs syndrome, Insomnia?


    24. Do you have anxiety, depression, heart disease, hepatic, pulmonary or renal disease?


    25. Do you suffer from any drug or alcohol abuse?


    26. Do you agreed to abstain from driving and operating dangerous machinery during the duration of the study? Y/N N=exclusion


    27. if smoker, Do you wake up in the middle of the night to smoke? Y/N Y=exclusion (If he doesn’t agreed to stop, is excluded)


    28. Do you have a usual bedtime later than 12am or work during the night? Y/N y=excluded


    29. Do you have a history of major back surgery, back pain, and/or injury?


    30. Do you have any vertebral deformities (scoliosis or kyphosis)?


    31. Do you have any allergy to anesthesia? Y/N y=exclusion


    32. Do you have any known bleeding abnormality, such as thrombocytopenia? Y/N y=excluded


    Study objective: The main purpose of this study is to look at how safe and how well the body handles taking this medication. The study will also look at how your body processes the study drug and how the study drug affects your body and symptoms of your narcolepsy , such as your wakefulness and alertness, or if your cataplexy occurs less frequently

Qualified Participants May Receive:

Compensation Up To : 4,000

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.