Obstructive Sleep ApneaPhase 3NCT00078325

Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)

A Phase 3 study testing Armodafinil 250 mg/day and Armodafinil 150 mg/day in people with Obstructive Sleep Apnea and Hypopnea, run by Cephalon.

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obstructive Sleep Apnea, Hypopnea
What is being tested?: Armodafinil 250 mg/day and Armodafinil 150 mg/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 395 participants
Where: No sites listed yet
Study dates: Feb 2004to Nov 2004
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.
The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
The patient meets the following nCPAP therapy requirements:

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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 shown to be effective, with effectiveness defined as having an apnea-hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy.
Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2-week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights).
The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using 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]) and agree to continued use of this method for the duration of the study.
The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more.
The patient has an ESS score of 10 or more.
The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
The patient is able to complete self rating scales and computer-based testing.
The patient is 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:
has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
has a probable diagnosis of a current sleep disorder other than OSAHS
consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine 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 second screening visit
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)

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has a positive urine drug screen (UDS)
has a clinically significant deviation from normal in the physical examination
is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
has used an investigational drug within 1 month before the initial screening visit
has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
has a known clinically significant drug sensitivity to stimulants or modafinil

About this study

Official title: A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.

Conditions: Obstructive Sleep Apnea, Hypopnea
Being tested: Armodafinil 250 mg/day, Armodafinil 150 mg/day, Placebo
Keywords: Excessive Sleepiness, Obstructive Sleep Apnea, Obstructive Sleep Hypopnea, nCPAP, Cephalon, Cephalon, Inc, NUVIGIL
Medical subject headings: Sleep Apnea, Obstructive, Disorders of Excessive Somnolence

What participants receive

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

Armodafinil 250 mg/dayDrug
Also called NUVIGIL, CEP-10953
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg/dayDrug
Also called NUVIGIL, CEP-10953
Armodafinil 150 mg once daily in the morning
PlaceboDrug
Matching placebo tablets once daily in the morning

Study groups in NCT00078325
Study group	Role	What they receive
1	Experimental	Armodafinil 250 mg/day Receives: Drug: Armodafinil 250 mg/day
2	Experimental	Armodafinil 150 mg/day Receives: Drug: Armodafinil 150 mg/day
3	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Maintenance of Wakefulness Test (MWT)
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
Measured: change from baseline at 12 weeks
Clinical Global Impression of Change (CGI-C)
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
Measured: change from baseline at 12 weeks

Timeline

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

Feb 2004Nov 2004

First posted25 Feb 2004 (estimated)
Study startFeb 2004
Primary completionNov 2004
Study completionNov 2004

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 Obstructive Sleep ApneaStudies 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: 395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00078325
Sponsor's protocol ID: C10953/3021/AP/MN
Status last verified: Jul 2013
First submitted: 23 Feb 2004
Last updated: 19 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

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 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
ClinicalTrials.gov ID: NCT00078325
Acronym / sponsor ID: C10953/3021/AP/MN
Conditions: Obstructive Sleep Apnea, Hypopnea
Keywords: Excessive Sleepiness, Obstructive Sleep Apnea, Obstructive Sleep Hypopnea, nCPAP, Cephalon, Cephalon, Inc, NUVIGIL
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 395 participants (actual)
Lead sponsor: CephalonIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Nov 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 25 Feb 2004 (estimated)
Results: Posted 29 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Armodafinil 250 mg/dayArmodafinil 250 mg/day
2	Experimental	Drug: Armodafinil 150 mg/dayArmodafinil 150 mg/day
3	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 (17 listed)

Written informed consent is obtained.
The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
The patient meets the following nCPAP therapy requirements:

Key exclusion criteria (12 listed)

Patients are excluded from participating in this study if 1 or more of the following criteria are met:
has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
has a probable diagnosis of a current sleep disorder other than OSAHS
consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine 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 second 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 250 mg/dayAlso: NUVIGIL, CEP-10953Armodafinil 250 mg once daily in the morning	Drug	1
Armodafinil 150 mg/dayAlso: NUVIGIL, CEP-10953Armodafinil 150 mg once daily in the morning	Drug	2
PlaceboMatching placebo tablets once daily in the morning	Drug	3

Primary outcome

Maintenance of Wakefulness Test (MWT)
Time frame: change from baseline at 12 weeks
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
Clinical Global Impression of Change (CGI-C)
Time frame: change from baseline at 12 weeks
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

Results and safety

Results posted to the registry on 29 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Armodafinil 250 mg/Day	131	110
Armodafinil 150 mg/Day	133	114
Placebo	131	120

Primary outcome: Maintenance of Wakefulness Test (MWT)

Time frame: change from baseline at 12 weeks. Mean (Standard Deviation). Unit: Minutes

Measure	Armodafinil 250 mg/Day n = 121	Armodafinil 150 mg/Day n = 120	Placebo n = 124
Value	2.2 (8.07)	1.7 (6.49)	-1.7 (8.59)

Armodafinil 250 mg/Day vs Placebo: p = 0.0001, ANOVA
Armodafinil 150 mg/Day vs Placebo: p = 0.0008, ANOVA

Population analysed: Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up) Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy.

Primary outcome: Clinical Global Impression of Change (CGI-C)

Time frame: change from baseline at 12 weeks. Number. Unit: Participants

Measure	Armodafinil 250 mg/Day n = 121	Armodafinil 150 mg/Day n = 120	Placebo n = 124
Value	121	120	124

Armodafinil 250 mg/Day vs Placebo: p <0.0001, Cochran-Mantel-Haenszel
Armodafinil 150 mg/Day vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Armodafinil 250 mg/Day	1 of 131 (0.8%)	52 of 131 (39.7%)	Not reported
Armodafinil 150 mg/Day	3 of 131 (2.3%)	32 of 131 (24.4%)	Not reported
Placebo	0 of 130 (0%)	19 of 130 (14.6%)	Not reported

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.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
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Obstructive Sleep Apnea

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Armodafinil 250 mg/day and Armodafinil 150 mg/day in people with Obstructive Sleep Apnea and Hypopnea, run by Cephalon.

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 17 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.

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 29 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?

Maintenance of Wakefulness Test (MWT) (time frame: change from baseline at 12 weeks). 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 NCT00078325.

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.