Narcolepsy With Cataplexy Studies

Takeda 994-1501

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

  • PI:  ANDREA HALLER, MD
  • CONTACT MINDY EXT 2185
  • Phase 2 study
  • Part B NTI Duration 56 days
  • Part D NT2 Duration 28 days
  • VERY STRICT STUDY SCHEDULE.

KEY INCLUSION CRITERIA

  • Ages 18 to 65
  • MUST NOT DRIVE DURING THE DURATION OF THE STUDY.
  • Require washout of stimulants-Provigil, Nuvigil-7 days   Wakix and Sunosi-4 weeks

KEY EXCLUSION CRITERIA

  • Moderate to severe sleep apnea
  • Excessive caffeine use >600 mg per day
  • No third shift workers.

AVADEL-CLFT218-1901

An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy.

  • PI:  JAMES STEVENS, MD
  • CONTACT MINDY
  • PHASE 3   DURATION 2 YEAR STUDY

KEY INCLUSION CRITERIA

  • Are receiving a stable doses of twice-nightly sodium oxybate IR for at least 4 weeks and are willing to switch to FT218.
  • Subjects16 years of age and older.
  • Subjects may use concomitant stimulants, but must comply with the following: a. Stable regimen of stimulants for at least 3 weeks prior to entering the study
  • Willing to adhere to all study restrictions including a. Comply with the requirement to remain in bed for a minimum of 6 hours after taking the investigational product.
  • Refrain from operating a car or heavy machinery, if determined necessary by the investigator, or refrain from operating a car or heavy machinery for at least 6 hours after taking the nightly dose of investigational product.
  • Avoid alcohol for the duration of the clinical study
  • Abstain from cannabis

KEY EXCLUSION CRITERIA

  • Any use of the following prohibited medications for the duration of the clinical study: a. Anticonvulsants b. Clonidine c. Hypnotics d. Anxiolytics e. Sedating antihistamines f. Antipsychotics g. Other experimental medications designed to treat narcolepsy, cataplexy, or any other condition h. Other medications with significant sedating effects/CNS depressant effects.    NO sleep apnea.