Excessive SleepinessPhase 3NCT00758498
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
A Phase 3 study testing armodafinil in people with Excessive Sleepiness, run by Cephalon at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Sleepiness
- What is being tested?
- armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2008to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Neurotrials Research, Inc.
Atlanta, Georgia, 30342
SleepMed of South Carolina
Columbia, South Carolina, 29201
Community Research
Crestview, Kentucky, 45217
Clinilabs, Inc.
New York, New York, 10019
About this study
Official title: 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
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.
- Conditions
- Excessive Sleepiness
- Being tested
- armodafinil, placebo
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
armodafinilDrug
50 mg/day orally, once daily in the morning for 3 days
armodafinilDrug
150 mg/day orally, once daily in the morning for 3 days
placeboDrug
placebo tablets, once daily in the morning for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | armodafinil - dosage of 50 mg/day Receives: Drug: armodafinil |
| 2 | Experimental | armodafinil - dosage of 150 mg/day Receives: Drug: armodafinil |
| 3 | Placebo comparator | matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across 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.
Measured: Days 1 and 2
Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across 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.
Measured: Days 1 and 2
Secondary outcomes (24)
Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here.
Measured: Days 1 and 2
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here.
Measured: Day 1
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here.
Measured: Day 2
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here.
Measured: Day 3
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here.
Measured: Baseline prior to starting study medication
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here.
Measured: Day 1 bedtime
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here.
Measured: Day 2 bedtime
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3
The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).
The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here.
Measured: Day 3 bedtime
Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline
MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). 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-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.
Measured: 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
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). 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-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.
Measured: Day 1
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). 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-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.
Measured: Day 2
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3
MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). 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-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.
Measured: Day 3
Mean Patient Global Impression of Severity of General Condition Ratings at Baseline
The PGI-S rating scale is the patient's assessment of 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 to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here.
Measured: Baseline, prior to start of study drug dosing
Mean Patient Global Impression of Severity of General Condition Ratings at Day 1
The PGI-S rating scale is the patient's assessment of 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 to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here.
Measured: Day 1
Mean Patient Global Impression of Severity of General Condition Ratings at Day 2
The PGI-S rating scale is the patient's assessment of 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 to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here.
Measured: Day 2
Mean Patient Global Impression of Severity of General Condition Ratings at Day 3
The PGI-S rating scale is the patient's assessment of 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 to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here.
Measured: Day 3
Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.
Measured: 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
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.
Measured: Day 1
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.
Measured: Day 2
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3
The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.
Measured: Day 3
Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.
Measured: Baseline and Day 2 (Endpoint)
Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.
Measured: Baseline and Day 2 (Endpoint)
Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.
Measured: Baseline and Day 2 (Endpoint)
Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography
Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.
Measured: Baseline and Day 2 (Endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758498
- Sponsor's protocol ID
- C10953/3065/ES/MN
- Status last verified
- Jul 2013
- First submitted
- 23 Sep 2008
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rosenberg RP, Bogan RK, Tiller JM, Yang R, Youakim JM, Earl CQ, Roth T. A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder. Mayo Clin Proc. 2010 Jul;85(7):630-8. doi: 10.4065/mcp.2009.0778. Epub 2010 Jun 7.
PubMed 20530317
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00758498
- Acronym / sponsor ID
- C10953/3065/ES/MN
- Conditions
- Excessive Sleepiness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 8 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: armodafinilarmodafinil - dosage of 50 mg/day |
| 2 | Experimental | Drug: armodafinilarmodafinil - dosage of 150 mg/day |
| 3 | Placebo comparator | Drug: placebomatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| armodafinil50 mg/day orally, once daily in the morning for 3 days | Drug | 1 |
| armodafinil150 mg/day orally, once daily in the morning for 3 days | Drug | 2 |
| placeboplacebo tablets, once daily in the morning for 3 days | Drug | 3 |
Primary outcome
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.
24 secondary outcomes
Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)
Time frame: Days 1 and 2
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1
Time frame: Day 1
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2
Time frame: Day 2
Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3
Time frame: Day 3
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline
Time frame: Baseline prior to starting study medication
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1
Time frame: Day 1 bedtime
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2
Time frame: Day 2 bedtime
Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3
Time frame: Day 3 bedtime
Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline
Time frame: 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
Time frame: Day 1
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2
Time frame: Day 2
Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3
Time frame: Day 3
Mean Patient Global Impression of Severity of General Condition Ratings at Baseline
Time frame: Baseline, prior to start of study drug dosing
Mean Patient Global Impression of Severity of General Condition Ratings at Day 1
Time frame: Day 1
Mean Patient Global Impression of Severity of General Condition Ratings at Day 2
Time frame: Day 2
Mean Patient Global Impression of Severity of General Condition Ratings at Day 3
Time frame: Day 3
Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint
Time frame: 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
Time frame: Day 1
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2
Time frame: Day 2
Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3
Time frame: Day 3
Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography
Time frame: Baseline and Day 2 (Endpoint)
Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography
Time frame: Baseline and Day 2 (Endpoint)
Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography
Time frame: Baseline and Day 2 (Endpoint)
Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography
Time frame: Baseline and Day 2 (Endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20530317Rosenberg RP, Bogan RK, Tiller JM, Yang R, Youakim JM, Earl CQ, Roth T. A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder. Mayo Clin Proc. 2010 Jul;85(7):630-8. doi: 10.4065/mcp.2009.0778. Epub 2010 Jun 7.
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Stroke, Sleep Apnea Syndrome (OSAS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor's Medical Expert study director
Cephalon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing armodafinil in people with Excessive Sleepiness, run by Cephalon at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00758498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.