This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mo… (NCT05015673) | Clinical Trial Compass
CompletedPhase 1
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
United States18 participantsStarted 2014-06-05
Plain-language summary
This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject must give written informed consent and privacy authorization prior to participation in the study. Female subjects of childbearing potential and male subjects must agree to contraceptive requirements outlined in the informed consent form (ICF).
✓. Subject must be willing and able to comply with the study procedures and visit schedules and must be able to follow verbal and written instructions.
✓. Male or female subject between 18 to 55 years of age, inclusive, with narcolepsy-cataplexy (confirmation of diagnosis may occur during screening period).
✓. Subject's body mass index (BMI) must be at least 16 kg/m2 but no more than 32 kg/m2
✓. Subjects on medications for cataplexy (ie, selective serotonin reuptake inhibitors \[SSRIs\], serotonin and norepinephrine reuptake inhibitors \[SNRIs\], norepinephrine reuptake inhibitors \[NRIs\], tricyclic antidepressants \[TCAs\], or Xyrem) and/or EDS associated with narcolepsy (ie, modafinil, armodafinil, or classical stimulants such as methylphenidate and amphetamine), and/or over-the-counter (OTC) medications known to affect sleep-wake functions must washout the prohibited medications during the 2 weeks (or 5 half-lives) prior to BL-1.
✓. Subject must have a negative urine drug screen (UDS) for drugs of abuse at the screening visit
✓. Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until 60 days after the last study drug administration.
✓. Female subjects must have a negative serum pregnancy test at screening.
Exclusion criteria
What they're measuring
1
Change from baseline in the total number of cataplexy attacks over the 2-week treatment period as assessed by the cataplexy diary.
Timeframe: Baseline and Week 2
2
Clinical Global Impression-Improvement (CGI-I)at the end of the 2-week treatment period to assess change in narcolepsy-cataplexy symptoms
Timeframe: Week 2
Trial details
NCT IDNCT05015673
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
✕. Subject has symptoms of any sleeping disorder other than narcolepsy-cataplexy as determined by the screening sleep history form administered by site personnel.
✕. Subject is a rotating or third-shift worker, is expected to travel (eg, transcontinental flights over 2 time zones), during the course of the study, or has a lifestyle within the prior 3 months that is disruptive to establishing a normal sleep pattern.
✕. Subject does not tolerate venipuncture or has poor venous access that would cause difficulty in collecting blood samples.
✕. Subject has participated in an investigational drug study and received investigational drug within 30 days (or longer if the elimination half-life is known to be ≥ 150 hours) prior to the screening visit, or who is currently participating in another clinical study.
✕. Subject has any clinically significant unstable acute or chronic medical condition that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
✕. Hematologic (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urologic, cardiovascular, hepatic, neurologic, or allergic disease (except for untreated, asymptomatic, seasonal allergies at the time of dosing).
✕. History of any allergic reaction to any medication.
✕. Presence or history of a medically diagnosed, clinically significant psychiatric disorder (including mental retardation).