- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078377
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
July 12, 2013 updated by: Cephalon
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
196
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
Placebo
|
Matching placebo tablets once daily
|
Experimental: 1
Armodafinil 250 mg
|
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg once daily in the morning
|
Experimental: 2
Armodafinil 150 mg
|
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg once daily in the morning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 at 12 weeks
|
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.
|
change from baseline at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
February 24, 2004
First Submitted That Met QC Criteria
February 25, 2004
First Posted (Estimate)
February 26, 2004
Study Record Updates
Last Update Posted (Estimate)
July 19, 2013
Last Update Submitted That Met QC Criteria
July 12, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disorders of Excessive Somnolence
- Sleepiness
- Narcolepsy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- C10953/3020/NA/MN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Narcolepsy
-
University of Dublin, Trinity CollegeSt. James's Hospital, IrelandSuspendedNarcolepsy | Hypersomnolence | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy 1 | Narcolepsy and HypersomniaIreland
-
Northwestern UniversityActive, not recruitingNarcolepsy | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Narcolepsy Type 2United States
-
Northwestern UniversityNot yet recruitingNightmare | Narcolepsy | Narcolepsy Type 1 | Narcolepsy Without Cataplexy | Narcolepsy With Cataplexy | Nightmare Disorder With Associated Other Sleep Disorder
-
NLS PharmaceuticsCompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
Boston Children's HospitalAmerican Academy of Sleep MedicineRecruitingIdiopathic Hypersomnia | Narcolepsy Type 1 | Narcolepsy Type 2United States
-
NLS PharmaceuticsNot yet recruitingNarcolepsy Type 1 | Narcolepsy With Cataplexy
-
TakedaRecruitingNarcolepsy Type 1 | Narcolepsy Type 2Spain, Germany, United States, Italy, Netherlands, Japan, France, Norway, Australia, Finland, Switzerland, Sweden
-
Northwestern UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedNarcolepsy | Narcolepsy Without Cataplexy | Narcolepsy With CataplexyUnited States
-
BioprojetActive, not recruitingNarcolepsy Without Cataplexy | Narcolepsy With CataplexyFrance, Italy, Russian Federation, Finland, Netherlands
-
TakedaTerminatedNarcolepsy Type 1 (NT1) | Narcolepsy Type 2 (NT2)China, United States, Korea, Republic of, France, Italy, Finland, Spain, Czechia, Canada, Japan, Hungary, Netherlands
Clinical Trials on Armodafinil
-
CephalonCompletedChronic Shift Work Sleep DisorderUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedFatigueUnited States
-
University of FloridaCompleted
-
CephalonCompletedObstructive Sleep Apnea | Hypopnea
-
Eisai Inc.PPD; Covance; Quest Pharmaceutical ServicesTerminated
-
Eisai Inc.PPD; Covance; Quest Pharmaceutical ServicesTerminated
-
CephalonCompletedNarcolepsy | Excessive Daytime Sleepiness | Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)United States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedFatigue | Cognition Disorders | Brain Tumors | Nervous System TumorsUnited States
-
CephalonCompletedObstructive Sleep Apnea | Major Depressive Disorder | Sleep Disorders | Dysthymic DisorderUnited States
-
NYU Langone HealthCephalonWithdrawnParkinsons Disease | Lewy Bodies DiseaseUnited States