Chronic Shift Work Sleep Disorder, Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome
Conditions
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
Interventions
DRUGArmodafinil 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).
Sponsors
Cephalon
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) | End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year | 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. |
Countries
Australia, Canada, France, Germany, Puerto Rico, Russia, United States
Participant flow
Recruitment details
99 centers in the US, Canada, France, Germany, Russia, and Australia. First participant enrolled: 15 May 2004/ Last participant last visit: 19 July 2006
Pre-assignment details
12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
Participants by arm
| Arm | Count |
|---|---|
| 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) | 731 |
| Total | 731 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 112 |
| Overall Study | Lack of Efficacy | 34 |
| Overall Study | Lost to Follow-up | 67 |
| Overall Study | Miscellaneous | 46 |
| Overall Study | Physician Decision | 48 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 115 |
Baseline characteristics
| Characteristic | Armodafinil 100 to 250 mg/Day |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 726 Participants |
| Age Continuous | 46.7 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment Australia | 25 participants |
| Region of Enrollment Canada | 70 participants |
| Region of Enrollment France | 8 participants |
| Region of Enrollment Germany | 13 participants |
| Region of Enrollment Russian Federation | 16 participants |
| Region of Enrollment United States | 611 participants |
| Sex: Female, Male Female | 257 Participants |
| Sex: Female, Male Male | 474 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 667 / 731 |
| serious Total, serious adverse events | 56 / 731 |
Outcome results
Primary
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.
Time frame: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
Population: Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Armodafinil 100 to 250 mg/Day | Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) | 667 Participants |