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Phase 1 Completed N=26 Randomized Double-blind Treatment

Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)

Source: ClinicalTrials.gov NCT01300455 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Mean Apnea-Hypopnea Index (AHI) — 17.07; 14.41 Events per hour

Summary

This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce a clinically significant increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Apnea-Hypopnea Index (AHI)
17.07; 14.41
PRIMARY
Number of Participants With an Adverse Event
8; 4
PRIMARY
Number of Participants Who Discontinued Study Drug Due to an AE
0; 0
SECONDARY
Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
94.12; 94.15; 94.15; 94.21
SECONDARY
Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%
3.31; 2.57; 0.48; 0.24; NA; NA
SECONDARY
Mean Arterial SaO2 for Different Sleep Stages
94.08; 94.14; 94.12; 94.07; 94.42; 94.94
SECONDARY
Mean AHI
16.25; 16.72

Eligibility Criteria

Inclusion Criteria

  • Female participants of reproductive potential must demonstrate a serum β-human chorionic gonadotrophin (hCG) level consistent with the nongravid state at the pre-study (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the pre-study visit throughout the study.
  • Women who are postmenopausal without menses for at least 1 year and a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, and/or are status post hysterectomy, oophorectomy or tubal ligation may participate.
  • Participants with a Body Mass Index (BMI) ≤40 kg/m2 at the pre-study (screening) visit.
  • Participants have to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
  • Participants without clinically significant abnormality on electrocardiogram (ECG) performed at the pre-study (screening) visit and/or prior to administration of the initial dose of study drug.
  • Participants have an International Classification of Sleep Disorders diagnosis of OSA.
  • Participants have confirmed mild or moderate OSA (defined as mild

OSA with AHI ≥5 and 1.5 x the upper limit of normal (x ULN), aspartate transaminase (AST) >1.5 x ULN, total bilirubin >1.5 x ULN, or serum creatinine of >2 mg/dL.

  • Participants have a history or diagnosis of narcolepsy, cataplexy (familial or idiopathic), circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder, periodic limb movement (PLM) disorder, restless legs syndrome, or primary hypersomnia.
  • Participants have a screening PSG recording with oxygen (O2) saturation 10 PLM per hour associated with an arousal (periodic limb movement arousal index [PLMAI]).
  • Participant is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. Participant who have had situational depression may be enrolled in the study at the discretion of the investigator.
  • Participant has lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; or, a psychiatric condition requiring treatment with a prohibited medication; or, other psychiatric condition that, in the investigator's opinion, would interfere with the participant's ability to participate in the study.
  • Participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab or ECG abnormality or other circumstances that might confound the results of the study, or interfere with the participant's participation for the full duration of the study.
  • Participant has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years.
  • Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Participants with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator.
  • Participant has a history of neoplastic disease except: 1. adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the study; 2. participants with other malignancies which have been successfully treated ≥10 years prior to the prestudy (screening) visit where, in the judgment of both the Investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment th
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01300455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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