Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)

Last updated: April 17, 2020
Sponsor: Millennium Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT04091425
TAK-925-2001
  • Ages 18-67
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime sleepiness (EDS) despite adequate use of CPAP as the primary OSA therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has OSA diagnosed according to the international classification of sleep disorders-3 (ICSD-3) criteria and with current use of CPAP.

  • Has a complaint of EDS despite "consistent use" of CPAP as defined by machine trackingtime as having at least 4 hours of CPAP use/night on at least 70% during theapproximately 1 month before randomization.

  • If taking a stimulant medication for the treatment of excessive daytime sleepinessmust be willing to discontinue medication before randomization into the study.

  • Has a regular bedtime between 21:00 and 24:00 as verified by history and regular timein bed averaging between 7.5 and 9.0 hours/night and gets at least 6.5 hours/night onaverage of sleep, as defined by approximately 7 days of actigraphy supported by asleep diary, which are completed at least 1 week before Study Day-2.

  • Has a Epworth sleepiness scale (ESS) score of ≥10 at screening and Study Day -2, withor without stimulants.

  • Nocturnal polysomnography (NPSG) demonstrates that the participant does not have othercomorbid sleep disorders or clinically significant nocturnal hypoxemia (O2 saturation ≤80% for ≥5% of total sleep time) and that their apnea-hypopnea index (AHI) is ≤10.

  • Has an average (of 4 sessions) baseline MWT sleep latency less than or equal to 20minutes and no single session has a sleep latency of greater than 30 minutes asdetermined by the site investigator.

Exclusion

Exclusion Criteria:

  • Has supine or standing average systolic blood pressure (SBP) ≥140 millimeters ofmercury (mm Hg) or average diastolic blood pressure (DBP) ≥90 mm Hg at screening orStudy Day-2; blood pressures will be averaged over 3 readings done 10 minutes (min)apart.

  • A screening electrocardiogram (ECG) reveals a QT interval with Fridericia correctionmethod >450 milliseconds (ms) (men) or >470 ms (women).

  • Has a usual bedtime later than 01:00 or an occupation requiring nighttime shift workor variable shift work within the past 6 months or travel with significant jet lagwithin 14 days before Study Day-2.

  • Short sleepers with chronic sleep deprivation who get on average less than 7.5hours/night time in bed and/or less than 6.5 hours of sleep per night as defined byapproximately 1 week of nocturnal actigraphy testing and supported by a sleep diary,both of which are completed at least 1 week before Study Day -2 admission to theclinical unit.

  • Has a history of a sleep disorder other than OSA that is associated with EDS on thebasis of interviews at the screening visit, such as, for example, restless legssyndrome, confirmed by prior pretreatment polysomnography (PSG) data demonstratingperiodic limb movement during sleep (PLMS) >15.

  • Has used any over-the-counter (OTC) or prescription medications with stimulatingproperties within 7 days before dosing or 5 half-lives (whichever is longer) thatcould affect the evaluation of EDS or any use of sodium oxybate within 3 months ofscreening.

  • Has nicotine dependence that is likely to have an effect on sleep (e.g., a participantwho routinely awakens at night to smoke) or challenge the conduct of this study (smokes ≥10 cigarettes/day) and/or the participant is unwilling to discontinue allsmoking and nicotine use during the study.

  • Has a caffeine consumption of more than 600 mg/day for 7 days before Study Day-1 (1serving of coffee is approximately equivalent to 120 mg of caffeine).

  • History or presence of any acutely unstable medical condition, behavioral orpsychiatric disorder (including active suicidal ideation), or surgical history thatcould affect the safety of the subject or interfere with study efficacy, safety, PKassessments, or the ability of the subject to complete the study per the judgment ofthe investigator.

Study Design

Total Participants: 25
Study Start date:
November 21, 2019
Estimated Completion Date:
April 02, 2020

Study Description

The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat participants who have EDS due to OSA despite using CPAP. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single IV dose of TAK-925 in participants with OSA.

The study will enroll approximately 42 patients. The study will utilize a three-way cross over design with a 24 hour wash-out between each treatment.

On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.

The multi-center study will be conducted in United States. The patient's participation in the study will last for up to 43 days and include an 8-day stay in the study clinic and a safety follow-up phone call 7 days after the end of treatment.

Connect with a study center

  • Wright Clinical Research

    Alabaster, Alabama 35007
    United States

    Site Not Available

  • Pulmonary Associates Clinical Trials

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Stanford School of Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • Pacific Research Network, Inc

    San Diego, California 92103
    United States

    Site Not Available

  • Delta Waves Sleep Disorders and Research Center

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • MD Clinical

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Pulmonary Disease Specialists, PA, d/b/a PDS Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida 32789
    United States

    Site Not Available

  • NeuroTrials Research, Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • SleepCare Research Institute, Inc. d/b/a Clinical Research Institute

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • CTI Clinical Trial and Consulting Services

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Sleep Therapy & Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

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