Excessive Daytime SleepinessPhase 3NCT00228566
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
A Phase 3 study testing Armodafinil in people with Excessive Daytime Sleepiness and Narcolepsy, run by Cephalon at 43 sites in United States.
Trial summary
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- What is being tested?
- Armodafinil
- How many people
- 247 participants
- Where
- 43 sitesUnited States
- Study dates
- Oct 2005to Jul 2006
- 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
- Written informed consent is obtained.
- The patient is a man or a woman aged 18 through 65 years of age (inclusive) and English-speaking.
- The patient has excessive sleepiness associated with a diagnosis of narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least 4 hours/night on at least 70% of nights), must have documented adequate education and intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy regimen must be stable for at least 4 weeks prior to study entry, and the patient's nCPAP therapy must be effective in the opinion of the investigator.
- The patient is in good health as determined by a medical and psychiatric history, clinical laboratory tests, vital signs measurements, electrocardiography (ECG), physical examination, and urine drug screen (UDS) at screening.
- If currently receiving therapy for excessive sleepiness associated with their sleep disorder, the patient is dissatisfied because of efficacy and/or safety with their current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for excessive sleepiness associated with their sleep disorder.
- The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating at baseline of 4 or more (i.e., at least moderately ill).
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- 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, or intrauterine device (IUD).
- The patient must be willing and able to comply with study procedures and restrictions, including the completion of self-rating scales, and be willing to return to the study center for visits as specified in this protocol.
- The patient may have been prescribed pharmacologic therapy for excessive sleepiness associated with a sleep disorder; however, they must have undergone a washout period of at least 7 days prior to the baseline visit.
Who cannot join
- Patients are excluded from participating in this study if any of the following criteria are met:
- The patient has any treated or untreated clinically significant uncontrolled medical or psychiatric conditions.
- The patient has a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of excessive sleepiness.
- The patient consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine/day within 1 week of the start of study drug administration.
- The patient has a medically unexplainable positive UDS at the screening visit.
- The patient has a clinically significant deviation from normal in clinical laboratory test results, vital signs values, or physical examination findings observed at the screening visit.
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- The patient has used an investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration.
- The patient has used any prescription drugs disallowed by the protocol within 7 days before the baseline visit.
- The patient has a known or suspected hypersensitivity to armodafinil or any compound present in the study drug or related compounds.
- The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from the study).
- The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
- The patient has a history of alcohol, narcotic,or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) within the past 5 years.
- The patient has a history of repeated therapeutic failure to therapies for excessive sleepiness.
- The patient previously participated in a clinical study with armodafinil.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Neurology and Neuro Science Associates
Akron, Ohio, 44302
Metroplex Pulmonary and Sleep Center, PA
Allen, Texas, 75013
Advanced Clinical Research Institute
Anaheim, California, 92801
Child Neurology Associates, PC
Atlanta, Georgia, 30342
Neurotrials, Inc.
Atlanta, Georgia, 30342
FutureSearch Trials
Austin, Texas, 78756
North Coast Clinical Trials, Inc.
Beechwood, Ohio, 44122
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
SleepMed of South Carolina
Columbia, South Carolina, 29201
Colorado Sleep Disorder Center
Englewood, Colorado, 80113
Vermont Medical Sleep Disorders Center
Essex Junction, Vermont, 05452
Evanston Northwestern Healthcare, Evanston Hospital
Evanston, Illinois, 60201
Cumberland Research Associates
Fayetteville, North Carolina, 28304
Pacific Institute of Medical Science
Kirkland, Washington, 98034
Neurology and Clinical Study Center
Little Rock, Arkansas, 72205
West Coast Clinical Trials, Inc
Long Beach, California, 90806
Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists
Louisville, Kentucky, 40217
Sleepmed Inc.
Macon, Georgia, 31201
Healthstar Physicians
Morristown, Tennessee, 37813
Sleep Medicine of Tennesse
Nashville, Tennessee, 37205
Neurocare. Inc
Newton, Massachusetts, 02459
Jonathan Schwartz
Oklahoma City, Oklahoma, 73109
Neuro-Therapeutics, Inc
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pulmonary Associates
Phoenix, Arizona, 85006
HOPE Research Institute
Phoenix, Arizona, 85032
PsyPharm Clinical Research
Phoenix, Arizona, 85050
Sleep Medicine Associates of Texas, P.A
Plano, Texas, 75093
Pacific Sleep Program
Portland, Oregon, 97209
Penninsula Research Associates
Rolling Hills Estates, California, 90274
Texas Association of Pediatric Neurology
San Antonio, Texas, 78258
Pacific Sleep Program
San Francisco, California, 94109
The Sleep Disorders Center of Santa Barbara
Santa Barbara, California, 93103
Savannah Neuurology
Savannah, Georgia, 31405
Pacific Institute of Mental Health
Seattle, Washington, 98133
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707
PsyPharm Clinical Research Inc.
Tucson, Arizona, 85712
Neurology Consultants of Tuscaloosa, P.C.
Tuscaloosa, Alabama, 35406
Crozer Chester Medical Center
Upland, Pennsylvania, 19013
Sleep Disorders Center of the Mid Atlantic
Vienna, Virginia, 22182
Convenant Clinic
Waterloo, Iowa, 50702
University Services
West Chester, Pennsylvania, 19380
About this study
Official title: A Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Being tested
- Armodafinil
- Medical subject headings
- Disorders of Excessive Somnolence, Narcolepsy, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
Measured: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startOct 2005
- Study completionJul 2006
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 Excessive Daytime 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sponsor's Medical Expert, MD, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228566
- Sponsor's protocol ID
- C10953/3046/ES/US
- Status last verified
- Jul 2013
- First submitted
- 27 Sep 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 Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT00228566
- Acronym / sponsor ID
- C10953/3046/ES/US
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Posted 25 Jun 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 this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent is obtained.
- The patient is a man or a woman aged 18 through 65 years of age (inclusive) and English-speaking.
- The patient has excessive sleepiness associated with a diagnosis of narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least 4 hours/night on at least 70% of nights), must have documented adequate education and intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy regimen must be stable for at least 4 weeks prior to study entry, and the patient's nCPAP therapy must be effective in the opinion of the investigator.
- The patient is in good health as determined by a medical and psychiatric history, clinical laboratory tests, vital signs measurements, electrocardiography (ECG), physical examination, and urine drug screen (UDS) at screening.
- If currently receiving therapy for excessive sleepiness associated with their sleep disorder, the patient is dissatisfied because of efficacy and/or safety with their current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for excessive sleepiness associated with their sleep disorder.
Key exclusion criteria (14 listed)
- Patients are excluded from participating in this study if any of the following criteria are met:
- The patient has any treated or untreated clinically significant uncontrolled medical or psychiatric conditions.
- The patient has a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of excessive sleepiness.
- The patient consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine/day within 1 week of the start of study drug administration.
- The patient has a medically unexplainable positive UDS 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 |
|---|---|---|
| Armodafinil | Drug | – |
Primary outcome
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
Time frame: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
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.
Sponsor's Medical Expert, MD study director
Cephalon
43 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 Daytime Sleepiness and Narcolepsy, run by Cephalon at 43 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 9 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 43 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. 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 25 Jun 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?
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings (time frame: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.). 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.