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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00228553




Registration number
NCT00228553
Ethics application status
Date submitted
27/09/2005
Date registered
29/09/2005
Date last updated
19/07/2013

Titles & IDs
Public title
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Scientific 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)
Secondary ID [1] 0 0
C10953/3024/ES/MN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive Daytime Sleepiness 0 0
Narcolepsy 0 0
Obstructive Sleep Apnea/Hypopnea Syndrome 0 0
Chronic Shift Work Sleep Disorder 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Armodafinil 100 to 250 mg/day

Experimental: 1 - Armodafinil 100 to 250 mg/day


Treatment: Drugs: Armodafinil 100 to 250 mg/day
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).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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).

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. George Hospital - Kogarah
Recruitment hospital [3] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [4] 0 0
Monash Medical Center - Clayton
Recruitment hospital [5] 0 0
Melbourne Sleep Disorders Ctr. - East Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
- Wentworthville
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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United States of America
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California
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Mississippi
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United States of America
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Missouri
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Nevada
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New Jersey
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New York
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United States of America
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North Carolina
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North Dakota
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United States of America
State/province [22] 0 0
Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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United States of America
State/province [30] 0 0
Virginia
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United States of America
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Washington
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United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
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France
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Cedex 05
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France
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Cedex
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France
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Clamart
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France
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Creteil
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Germany
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Freiburg
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Germany
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Marburg
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Germany
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Regensburg
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Germany
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Schwalmstadt
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Puerto Rico
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San Juan
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
State/province [46] 0 0
Samara

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cephalon
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT00228553
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sponsor's Medical Director, MD
Address 0 0
Cephalon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications