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NarcolepsyPhase 3NCT00078312

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

A Phase 3 study testing CEP-10953 (Armodafinil) in people with Narcolepsy and Sleep Apnea, Obstructive, run by Cephalon at 50 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
CEP-10953 (Armodafinil)
How many people
328 participants
Where
50 sitesin 2 countries
Study dates
Jan 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:
  • Written informed consent is obtained.
  • Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
  • The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
  • Narcolepsy-Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.
  • OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
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  • Previous adequate education and intervention efforts to encourage nCPAP therapy use must be documented.
  • A patient's nCPAP therapy regimen must be stable for at least 4 weeks.
  • nCPAP therapy is effective, in the opinion of the investigator.
  • Evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of the nights).
  • Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study.
  • The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.)
  • The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. 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 may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments.
  • 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 or more than 8 cups of coffee per day
  • used any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before the baseline visit
  • 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)
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  • have a positive UDS at the screening visit
  • 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 used an investigational drug within 1 month before the screening visit
  • 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

50 sites in 2 countries.

50 sites in 2 countries

United States41 sites

  • Lehigh Valley Hospital Hospital

    Allentown, Pennsylvania, 18105

  • Michigan Head-Pain Neurological Institute

    Ann Arbor, Michigan, 48104

  • North Coast Clinical Trials, Inc

    Beachwood, Ohio, 44122

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • Radiant Research, Boise

    Boise, Idaho, 83704

  • Herron Medical Center, Ltd.

    Chicago, Illinois, 60610

  • Radiant Research, Chicago

    Chicago, Illinois, 60610

  • CNS Research Institute, PC

    Clementon, New Jersey, 08021

  • SleepMed of South Carolina

    Columbia, South Carolina, 29201

  • Radiant Research Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • Therafirst Medical Centers

    Fort Lauderdale, Florida, 33308

  • Marc Raphaelson, MD, PA

    Frederick, Maryland, 21702

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Precision Research

    Hallandale, Florida, 33009

  • Central Arkansas Research

    Hot Springs, Arkansas, 71913

  • Bay Area Research Institute

    Lafayette, California, 94549

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Somnos Laboratories, Inc

    Lincoln, Nebraska, 68510

  • Arkansas Center for Sleep Medicine

    Little Rock, Arkansas, 72205

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • North Shore University Hospital

    Manhasset, New York, 11030

  • NeuroTrials Research of New Orleans, LLC

    Metairie, Louisiana, 70001

  • Henry W. Lahmeyer, MD and Associates

    Northfield, Illinois, 60093

  • Renstar Medical Research

    Ocala, Florida, 34471

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Clinical Research Studies

    Oklahoma City, Oklahoma, 73109

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 66211

  • Neuro-Therapeutics Inc.

    Pasadena, California, 91105

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • Central Phoenix Medical Clinic, LLC

    Phoenix, Arizona, 85014

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Center for Sleep Disorders, Inc.

    Pottstown, Pennsylvania, 19464

  • Anderson Clinical Research

    Redlands, California, 92374

  • Radiant Research

    Salt Lake City, Utah, 84107

  • Radiant Research, San Antonio

    San Antonio, Texas, 78229

  • Synergy Clinical Research Center

    San Diego, California, 92105

  • BMR HealthQuest Clinical Trials

    San Diego, California, 92123

  • Clinical Research Group of St. Petersburg

    St. Petersburg, Florida, 33707

  • Radiant Research - Tucson

    Tucson, Arizona, 85710

  • Rocky Mountain Center for Clinical Research

    Wheat Ridge, Colorado, 80033

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Russia9 sites

  • Institute of Pulmonology

    Moscow, 105 077

  • Moscow City Somnological Center

    Moscow, 107 014

  • City Clinical Hospital No. 83

    Moscow, 115 682

  • United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation

    Moscow, 119 285

  • City Clinical Hospital No. 81

    Moscow, 127 644

  • Center of Rehabilitation of Presidential Medical Center

    Moscow, 143 088

  • Medical Sanitary Unit No. 122 of Saint-Petersburg

    Saint Petersburg, 194 291

  • Cardioclinic

    Saint Petersburg, 196 128

  • Clinic of Neurology and Neurosurgery of Saint Petersburg

    Saint Petersburg, 197 022

Other trials in Russia

About this study

Official title: A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Study of the Safety and Efficacy of 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)

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).

Being tested
CEP-10953 (Armodafinil)
Keywords
Excessive Sleepiness, Narcolepsy, Cataplexy, Sleep Attacks, Obstructive Sleep Apnea, Obstructive Sleep Hypopnea, nCPAP, Chronic Shift Work Sleep Disorder, Chronic SWSD, Circadian Rhythm Disorder, Shift Worker, Cepahlon, Cephalon, Inc, Nuvigil
Medical subject headings
Narcolepsy, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorders, Circadian Rhythm, Disorders of Excessive Somnolence, Cataplexy, Chronobiology Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEP-10953 (Armodafinil)Drug

    Armodafinil (po) 100 to 250 mg/day up to 12 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability as Measured by Number of Participants With Adverse Events

    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: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

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
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078312
Sponsor's protocol ID
C10953/3023/ES/MN
Status last verified
Jul 2013
First submitted
23 Feb 2004
Last updated
19 Jul 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CEP-10953 (Armodafinil) in people with Narcolepsy and Sleep Apnea, Obstructive, run by Cephalon at 50 sites in 2 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 15 inclusion and 12 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 50 sites in United States, Russia. 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 22 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?

Safety and Tolerability as Measured by Number of Participants With Adverse Events (time frame: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter). 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 NCT00078312.

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.

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