Chronic Shift Work Sleep DisorderPhase 3NCT00236080
Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
A Phase 3 study testing PROVIGIL 200 mg, Armodafinil 250 mg and Armodafinil 200 mg in people with Chronic Shift Work Sleep Disorder, run by Cephalon at 20 sites in United States.
Trial summary
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Shift Work Sleep Disorder
- What is being tested?
- PROVIGIL 200 mg, Armodafinil 250 mg and Armodafinil 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2005to Dec 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are included in the study if all of the following criteria are met:
- The patient speaks and writes in English.
- The patient is a man or woman of any ethnic origin aged 18 through 65 years.
- The patient is in good health as determined by a medical and psychiatric history, medical examination, serum chemistry, and hematology.
- The patient has a diagnosis of SWSD according to the International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months.
- The patient must be planning to work at least 3 to 5 nights (per week), of which at least 3 nights will be consecutive.
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- The patient must work night shifts that include at least 6 hours between 2200 and 0800 (+30 minutes) and be no longer than 12 hours (+30 minutes) in duration.
- The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT (average of naps at 0100, 0300, 0500, and 0700).
- The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more as it pertains to sleepiness during night shifts including the commute from work.
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted and injected) in conjunction with a barrier method, and intrauterine device (IUD).
- The patient is willing to comply with study restrictions and remain at the clinic overnight as required.
- The patient may have been prescribed PROVIGIL or stimulant therapy for their sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments done at the second screening visit.
Who cannot join
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- The patient has any clinically significant medical or psychiatric conditions (treated or untreated).
- The patient has a probable diagnosis of a current sleep disorder other than SWSD.
- The patient consumes caffeine including coffee, tea, and/or other caffeine-containing beverages or foods averaging more than 600 mg of caffeine/day within 2 weeks of the start of study drug administration.
- The patient has medically unexplainable positive urine drug screen (UDS) result at the screening visit.
- The patient has clinically significant deviation from normal in clinical laboratory results, vital signs, or physical examination.
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- The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before study drug adminstration.
- The patient used any prescription drugs disallowed by the protocol or clinical significant use of over-the-counter (OTC) drugs within 7 days before the second screening/baseline visit.
- The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
- The patient has known or suspected hypersensitivity to stimulants and/or modafinil or any ingredient present in the study drug.
- The patient has a history (within the past 5 years) of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual or Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR).
- The patient is a pregnant or lactating woman.
- The patient has donated, within 56 days prior to study drug administration, any blood or plasma in excess of 450 mL.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Neurotrials Research
Atlanta, Georgia, 30342
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Center for Sleep/Wake Disorder
Chevy Chase, Maryland, 20815
SleepMed of South Carolina
Columbia, South Carolina, 29201
Central Arkansas Research
Hot Springs, Arkansas, 71913
Clinical Rsch Center of Nevada
Las Vegas, Nevada, 89104
Pacific Sleep Medicine Service
Los Angeles, California, 90048
SLEEPMED, Inc.
Macon, Georgia, 31202
Clinilabs / Sleep Disorders In
New York, New York, 10025
Henry Lahmeyer, MD
Northfield, Illinois, 60093
Vince and Associates Clinical
Overland Park, Kansas, 66211
Psypharma Clinical Research
Phoenix, Arizona, 85050
Consolidated Clinical Trials
Pittsburgh, Pennsylvania, 15221
Wake Research Associates
Raleigh, North Carolina, 27612
Radiant Research Salt Lake
Salt Lake City, Utah, 84107
Pacific Sleep Medicine Service
San Diego, California, 92121
BMR HealthQuest
San Diego, California, 92123
Stanford University
Stanford, California, 94305
St. Vincent Mercy Medical Cent
Toledo, Ohio, 43608
PsyPharma Clinical Tucson
Tucson, Arizona, 85712
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil (150, 200, and 250 mg) and PROVIGIL® (200 mg) in Patients With Chronic Shift Work Sleep Disorder
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder
- Conditions
- Chronic Shift Work Sleep Disorder
- Being tested
- PROVIGIL 200 mg, Armodafinil 250 mg, Armodafinil 200 mg, Armodafinil 150 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROVIGIL 200 mgDrug
PROVIGIL 200 mg/day
Armodafinil 250 mgDrug
Armodafinil 250 mg/day
Armodafinil 200 mgDrug
Armodafinil 200 mg/day
Armodafinil 150 mgDrug
Armodafinil 150 mg/day
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PROVIGIL 200 mg/day Receives: Drug: PROVIGIL 200 mg |
| 2 | Experimental | Armodafinil 250 mg/day Receives: Drug: Armodafinil 250 mg |
| 3 | Experimental | Armodafinil 200 mg/day Receives: Drug: Armodafinil 200 mg |
| 4 | Experimental | Armodafinil 150 mg/day Receives: Drug: Armodafinil 150 mg |
| 5 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sleep Latency Test (MSLT)
The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.
Measured: Endpoint (Visit 4) change from baseline (Visit 2)
Psychomotor Vigilance Task (PVT)
The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.
Measured: Endpoint (Visit 4) change from baseline (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2005
- Study completionDec 2005
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.
- Other trials for Chronic Shift Work Sleep DisorderStudies 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
- Double blind
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gwendolyn Neibler, DO, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236080
- Sponsor's protocol ID
- C10953/3045/CM/US
- Status last verified
- Jul 2013
- First submitted
- 7 Oct 2005
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil (150, 200, and 250 mg) and PROVIGIL® (200 mg) in Patients With Chronic Shift Work Sleep Disorder
- ClinicalTrials.gov ID
- NCT00236080
- Acronym / sponsor ID
- C10953/3045/CM/US
- Conditions
- Chronic Shift Work Sleep Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Dec 2005
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 3 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PROVIGIL 200 mgPROVIGIL 200 mg/day |
| 2 | Experimental | Drug: Armodafinil 250 mgArmodafinil 250 mg/day |
| 3 | Experimental | Drug: Armodafinil 200 mgArmodafinil 200 mg/day |
| 4 | Experimental | Drug: Armodafinil 150 mgArmodafinil 150 mg/day |
| 5 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient speaks and writes in English.
- The patient is a man or woman of any ethnic origin aged 18 through 65 years.
- The patient is in good health as determined by a medical and psychiatric history, medical examination, serum chemistry, and hematology.
- The patient has a diagnosis of SWSD according to the International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months.
- The patient must be planning to work at least 3 to 5 nights (per week), of which at least 3 nights will be consecutive.
Key exclusion criteria (13 listed)
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- The patient has any clinically significant medical or psychiatric conditions (treated or untreated).
- The patient has a probable diagnosis of a current sleep disorder other than SWSD.
- The patient consumes caffeine including coffee, tea, and/or other caffeine-containing beverages or foods averaging more than 600 mg of caffeine/day within 2 weeks of the start of study drug administration.
- The patient has medically unexplainable positive urine drug screen (UDS) result at the screening visit.
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 |
|---|---|---|
| PROVIGIL 200 mgPROVIGIL 200 mg/day | Drug | 1 |
| Armodafinil 250 mgArmodafinil 250 mg/day | Drug | 2 |
| Armodafinil 200 mgArmodafinil 200 mg/day | Drug | 3 |
| Armodafinil 150 mgArmodafinil 150 mg/day | Drug | 4 |
| PlaceboMatching placebo tablets | Drug | 5 |
Primary outcome
Multiple Sleep Latency Test (MSLT)
Time frame: Endpoint (Visit 4) change from baseline (Visit 2)
The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.
Psychomotor Vigilance Task (PVT)
Time frame: Endpoint (Visit 4) change from baseline (Visit 2)
The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.
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.
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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.
Gwendolyn Neibler, DO study director
Cephalon
20 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 PROVIGIL 200 mg, Armodafinil 250 mg and Armodafinil 200 mg in people with Chronic Shift Work Sleep Disorder, run by Cephalon at 20 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 12 inclusion and 13 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 20 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 3 Feb 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?
Multiple Sleep Latency Test (MSLT) (time frame: Endpoint (Visit 4) change from baseline (Visit 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?
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.