NarcolepsyPhase 3NCT00078377

Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

A Phase 3 study testing Armodafinil in people with Narcolepsy, 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: Narcolepsy
What is being tested?: Armodafinil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: No sites listed yet
Study dates: Mar 2004to Jan 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

Diagnosis and Criteria for Inclusion:

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
The patient has a current diagnosis of narcolepsy according to ICSD criteria.
The patient is in good health as determined by a medical and psychiatric history, physical examination, electrocardiogram (ECG), and serum chemistry, hematology, and urinalysis.
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 mean sleep latency of 6 minutes or less as determined by the Multiple Sleep Latency Test (MSLT) (performed at 0900, 1100, 1300, and 1500).
The patient has a CGI-S (Clinical Global Impression of Severity of Illness) rating of 4 or more.
The patient does not have any medical or psychiatric disorders that could account for the excessive daytime 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.

Criteria for Exclusion:

Patients are excluded from participating in this study if 1 or more of the following criteria are met. The patient:

has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
has a probable diagnosis of a current sleep disorder other than narcolepsy
consumed 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)
has a positive UDS at the screening visit, without medical explanation
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 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 Excessive Sleepiness Associated With Narcolepsy

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 narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)

Conditions: Narcolepsy
Being tested: Armodafinil, Placebo
Keywords: Narcolepsy, Excessive Sleepiness, Cataplexy, Sleep Attacks, Excessive Sleepiness associated with Narcolepsy, Cephalon, Cephalon, Inc, Nuvigil
Medical subject headings: Narcolepsy, Disorders of Excessive Somnolence, Cataplexy

What participants receive

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

ArmodafinilDrug
Armodafinil 250 mg once daily in the morning
ArmodafinilDrug
Armodafinil 150 mg once daily in the morning
PlaceboDrug
Matching placebo tablets once daily

Study groups in NCT00078377
Study group	Role	What they receive
1	Experimental	Armodafinil 250 mg Receives: Drug: Armodafinil
2	Experimental	Armodafinil 150 mg Receives: Drug: Armodafinil
3	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
The Maintenance of Wakefulness Test (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 change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
Measured: change from baseline at 12 weeks
Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 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 was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 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.

Mar 2004Jan 2005

First posted26 Feb 2004 (estimated)
Study startMar 2004
Primary completionJan 2005
Study completionJan 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 NarcolepsyStudies 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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00078377
Sponsor's protocol ID: C10953/3020/NA/MN
Status last verified: Jul 2013
First submitted: 24 Feb 2004
Last updated: 19 Jul 2013
Results posted: Yes, on ClinicalTrials.gov

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

RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1

All Narcolepsy 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 Excessive Sleepiness Associated With Narcolepsy
ClinicalTrials.gov ID: NCT00078377
Acronym / sponsor ID: C10953/3020/NA/MN
Conditions: Narcolepsy
Keywords: Narcolepsy, Excessive Sleepiness, Cataplexy, Sleep Attacks, Excessive Sleepiness associated with Narcolepsy, Cephalon, Cephalon, Inc, Nuvigil
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: CephalonIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: Jan 2005 (actual)
Study completion: Jan 2005 (actual)
First posted: 26 Feb 2004 (estimated)
Results: Posted 21 Jan 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: ArmodafinilArmodafinil 250 mg
2	Experimental	Drug: ArmodafinilArmodafinil 150 mg
3	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
ArmodafinilArmodafinil 250 mg once daily in the morning	Drug	1
ArmodafinilArmodafinil 150 mg once daily in the morning	Drug	2
PlaceboMatching placebo tablets once daily	Drug	3

Primary outcome

Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
Time frame: change from baseline at 12 weeks
The Maintenance of Wakefulness Test (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 change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
Time frame: change from baseline at 12 weeks
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 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 was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 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 21 Jan 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	67	56
Armodafinil 150 mg/Day	65	49
Placebo	64	55

Primary outcome: Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks

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

Measure	Armodafinil 250 mg/Day n = 60	Armodafinil 150 mg/Day n = 58	Placebo n = 58	Armodafinil Combined Group (250 mg/Day and 150 mg/Day) n = 118
Value	2.6 (6.24)	1.3 (6.31)	-1.9 (6.87)	1.9 (6.28)

Armodafinil 250 mg/Day vs Armodafinil 150 mg/Day vs Placebo: Mean Difference (Final Values): 3.8 (95% CI 1.02 to 4.61), p = 0.0024, ANCOVA

Population analysed: Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up). Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy.

Primary outcome: Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks

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

Measure	Armodafinil 250 mg/Day n = 60	Armodafinil 150 mg/Day n = 58	Placebo n = 58	Armodafinil Combined Group (250 mg/Day and 150 mg/Day) n = 118
Value	60	58	58	118

Placebo vs Armodafinil Combined Group (250 mg/Day and 150 mg/Day): p <0.0001, Cochran-Mantel-Haenszel

Population analysed: Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up). Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Armodafinil 250 mg/Day	0 of 67 (0%)	29 of 67 (43.3%)	Not reported
Armodafinil 150 mg/Day	1 of 64 (1.6%)	21 of 64 (32.8%)	Not reported
Placebo	0 of 63 (0%)	11 of 63 (17.5%)	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 Narcolepsy

RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1

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 in people with Narcolepsy, 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?

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 21 Jan 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?

Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks (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 NCT00078377.

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.