A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 427
- Locations
- 4
- Primary Endpoint
- Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •History of jet lag symptoms during the past 5 years.
- •The subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ECG) and physical examination findings.
- •Women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study).
- •The subject is willing to comply with study restrictions and remain at the study center overnight, as required.
- •The subject must agree to refrain from alcohol use during the study.
- •The subject has a valid U.S. passport
Exclusion Criteria
- •The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder.
- •The subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant significant medical condition.
- •The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hypersensitivity reaction, or multiple allergies.
- •The subject has a history of deep vein thrombosis (DVT).
- •The subject has known human immunodeficiency virus (HIV).
- •The subject is pregnant or lactating.
- •The subject has used nicotine within the last 3 months.
- •The subject has a history of seizures, except for a single febrile seizure.
- •The subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures.
- •The subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings.
- •The subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics).
- •The subject has used an investigational drug within 1 month before the screening visit.
- •The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- •The subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
Arms & Interventions
1
armodafinil - dosage of 50 mg/day
Intervention: armodafinil (Drug)
2
armodafinil - dosage of 150 mg/day
Intervention: armodafinil (Drug)
3
matching placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2
Time Frame: Days 1 and 2
MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.
Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2
Time Frame: Days 1 and 2
The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term "ill" refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here.
Secondary Outcomes
- Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)(Days 1 and 2)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1(Day 1)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2(Day 2)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3(Day 3)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline(Baseline prior to starting study medication)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1(Day 1 bedtime)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2(Day 2 bedtime)
- Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3(Day 3 bedtime)
- Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline(Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1)
- Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1(Day 1)
- Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2(Day 2)
- Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3(Day 3)
- Mean Patient Global Impression of Severity of General Condition Ratings at Baseline(Baseline, prior to start of study drug dosing)
- Mean Patient Global Impression of Severity of General Condition Ratings at Day 1(Day 1)
- Mean Patient Global Impression of Severity of General Condition Ratings at Day 2(Day 2)
- Mean Patient Global Impression of Severity of General Condition Ratings at Day 3(Day 3)
- Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint(Endpoint defined as either Day 3 or last observation after baseline)
- Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1(Day 1)
- Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2(Day 2)
- Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3(Day 3)
- Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography(Baseline and Day 2 (Endpoint))
- Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography(Baseline and Day 2 (Endpoint))
- Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography(Baseline and Day 2 (Endpoint))
- Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography(Baseline and Day 2 (Endpoint))