Excessive Daytime SleepinessPhase 3NCT00228553
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A Phase 3 study testing Armodafinil 100 to 250 mg/day in people with Excessive Daytime Sleepiness and Narcolepsy, run by Cephalon at 100 sites in 7 countries.
Trial summary
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder 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
- What is being tested?
- Armodafinil 100 to 250 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 743 participants
- Where
- 100 sitesin 7 countries
- Study dates
- May 2004to 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
- Patients are included in the study if all of the following criteria are met:
- Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible.
- The patient has completed a cephalon-sponsored double-blind study (study C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and the investigator has recommended they be enrolled.
- Patients with OSAHS must continue to be regular users of nCPAP therapy, which the investigator considers to remain effective. Patients with chronic SWSD must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration.
- The patient is considered to be in good health.
- Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
- The patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Who cannot join
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Have any clinically significant, uncontrolled medical conditions (treated or untreated).
- Have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD.
- Consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine.
- Use any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before visit 1.
- Have a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IV) (American Psychiatric Association 1994).
Show all 11Show fewer
- Have a positive urine drug screen (UDS) (subjects enrolling in this open-label study within 7 days after completing the double-blind study may be enrolled without UDS results).
- Have a clinically significant deviation from normal in the physical examination.
- Are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study.
- Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Have a known clinically significant drug sensitivity to stimulants.
Trial locations and contacts
100 sites in 7 countries.
100 sites in 7 countries
United States74 sites
Advanced Clinical Research Ins
Anaheim, California, 92801
Neurotrials Research
Atlanta, Georgia, 30342
Sleep Disorders Center of GA
Atlanta, Georgia, 30342
FutureSearch Trials
Austin, Texas, 78703
North Coast Clinical Trials
Beechwood, Ohio, 44122
McLean Hospital
Belmont, Massachusetts, 02478
Southwestern Research
Beverly Hills, California, 90210
Sleep Disorders Ctr of Alabama
Birmingham, Alabama, 35213
St. Alexius Medical Center
Bismarck, North Dakota, 58501
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
PAB Clinical Research
Brandon, Florida, 33511
Capital Region Sleep Disorders
Carlisle, Pennsylvania, 17013
Lowcountry Lung and Critical
Charleston, South Carolina, 29406
Center for Sleep/Wake Disorder
Chevy Chase, Maryland, 20815
Community Research Management
Cincinnati, Ohio, 45219
Tri State Sleep Disorders Cent
Cincinnati, Ohio, 45246
CNS Research Institute
Clementon, New Jersey, 08021
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
SleepMed of South Carolina
Columbia, South Carolina, 29201
Community Research
Crestview, Kentucky, 45217
Sleep Medicine Institute
Dallas, Texas
Center for Sleep Disorders
Danville, Indiana, 46122
Dept Veterans Affairs Dayton
Dayton, Ohio, 45428
Ohio Sleep Medicine-Neurosci
Dublin, Ohio, 43017
Duke University Hospital
Durham, North Carolina, 27710
Regional Pulmonary and Sleep
Elkton, Maryland, 21021
Vital re:Search
Greensboro, North Carolina, 27408
Sleep Disorders Center
Hattiesburg, Mississippi, 39404
Neurology Associates of Hickor
Hickory, North Carolina, 28602
Central Arkansas Research
Hot Springs, Arkansas, 71913
Houston Sleep Center
Houston, Texas, 77024
VA Medical CenterSleep Diagnos
Houston, Texas, 77030
University of Iowa Hospitals
Iowa City, Iowa, 52242
Clinical Rsch Center of Nevada
Las Vegas, Nevada, 89104
Pacific Sleep Medicine Service
Los Angeles, California, 90048
Chest Medicine Associates DBA
Louisville, Kentucky, 40217
SLEEPMED, Inc.
Macon, Georgia, 31202
Radiant Research Marietta
Marietta, Georgia, 30060
Neurotrials Research of New Or
Metairie, Louisiana, 70001
Southwest Cleveland Sleep Cent
Middleburg Heights, Ohio, 44130
St. Thomas Sleep Disorders Cen
Nashville, Tennessee, 37205
New York University
New York, New York, 10016
Clinilabs / Sleep Disorders In
New York, New York, 10025
Neurocare, Inc.
Newton, Massachusetts, 02459
Sentara Norfolk General Hospit
Norfolk, Virginia, 23507
Henry Lahmeyer, MD
Northfield, Illinois, 60093
Vince and Associates Clinical
Overland Park, Kansas, 66211
Pacific Sleep Medicine Service
Palm Springs, California, 92262
Peoria Pulmonary Associates
Peoria, Illinois, 61603
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Psypharma Clinical Research
Phoenix, Arizona, 85050
Consolidated Clinical Trials
Pittsburgh, Pennsylvania, 15221
Wake Research Associates
Raleigh, North Carolina, 27612
Central Carolina Neurology Sle
Salisbury, North Carolina, 28144
Radiant Research Salt Lake
Salt Lake City, Utah, 84107
Radiant Research San Diego
San Diego, California, 92103
Pacific Sleep Medicine Service
San Diego, California, 92121
BMR HealthQuest
San Diego, California, 92123
Sleep Clinic of San Francisco
San Francisco, California, 94117
St. Johns Medical Plaza Sleep
Santa Monica, California, 90404
Swedish Sleep Medicine Institute
Seattle, Washington, 98122
Northshore Research Associates
Slidell, Louisiana, 70461
Washington University School o
St Louis, Missouri, 63105
St. Petersburg Sleep Disorder
St. Petersburg, Florida, 33707
Stanford University
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Sadler Clinic
The Woodlands, Texas, 77380
St. Vincent Mercy Medical Cent
Toledo, Ohio, 43608
Topeka Pulmonary
Topeka, Kansas, 66606
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 74104
Omega Medical Research
Warwick, Rhode Island, 02886
Allegiance Research Specialist
Wauwatosa, Wisconsin, 53226
All Trials Clinical Research
Winston-Salem, North Carolina
Sleep-Wake Disorder Center
Winter Park, Florida, 32789
Canada8 sites
Canadian Sleep Institute
Calgary, Alberta
Sleep Clinic
Kitchener, Ontario, N2G1G1
Niagara Clinical Research
Niagara Falls, Ontario
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
West Parry Sound Health Center
Parry Sound, Ontario, P2A 1T3
Sleep and Neuropsychiatry Cent
Scarborough Village, Ontario
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Baycrest Hospital
Toronto, Ontario
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales
Monash Medical Center
Clayton, Victoria
Melbourne Sleep Disorders Ctr.
East Melbourne, Victoria
St. George Hospital
Kogarah, New South Wales, 2217
Westmead Hospital
Wentworthville, New South Wales
France4 sites
Hopital Antoine Beclere
Clamart, Clamart, 92141
Hospital Henri-Mondor
Créteil, 94010
Hopital Guy de Chauliac
Montpellier, Cedex 05, 34295
Universitaires de Strasbourg
Strasbourg, Cedex, 67091
Germany4 sites
University of Freiburg
Freiburg im Breisgau, D-79104
Klinikum der Philipps
Marburg, 35033
University of Regensburg
Regensburg, D-93042
Hephata Klinik
Schwalmstadt, D-34613
Russia4 sites
City Clinical Hospital 33
Moscow
City Clinical Hospital 83
Moscow
Clinical Hospital Russian Scie
Saint Petersburg
Multifunction Center of Neurol
Samara
About this study
Official title: A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Being tested
- Armodafinil 100 to 250 mg/day
- 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.
Armodafinil 100 to 250 mg/dayDrug
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Armodafinil 100 to 250 mg/day Receives: Drug: Armodafinil 100 to 250 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
Measured: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
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 startMay 2004
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sponsor's Medical Director, MD, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228553
- Sponsor's protocol ID
- C10953/3024/ES/MN
- 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 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)
- ClinicalTrials.gov ID
- NCT00228553
- Acronym / sponsor ID
- C10953/3024/ES/MN
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Posted 31 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Armodafinil 100 to 250 mg/dayArmodafinil 100 to 250 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible.
- The patient has completed a cephalon-sponsored double-blind study (study C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and the investigator has recommended they be enrolled.
- Patients with OSAHS must continue to be regular users of nCPAP therapy, which the investigator considers to remain effective. Patients with chronic SWSD must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration.
- The patient is considered to be in good health.
- Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
Key exclusion criteria (11 listed)
- Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Have any clinically significant, uncontrolled medical conditions (treated or untreated).
- Have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD.
- Consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine.
- Use any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before visit 1.
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 100 to 250 mg/dayArmodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD). | Drug | 1 |
Primary outcome
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
Time frame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
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 Director, MD study director
Cephalon
100 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Armodafinil 100 to 250 mg/day in people with Excessive Daytime Sleepiness and Narcolepsy, run by Cephalon at 100 sites in 7 countries.
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 7 inclusion and 11 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 100 sites in United States, Canada, Australia, France, Germany and 2 more countries. 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 31 Mar 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?
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) (time frame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year). 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.