Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Conditions
Brief summary
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.
Interventions
DRUGArmodafinil
Sponsors
Cephalon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent is obtained. * The patient is a man or a woman aged 18 through 65 years of age (inclusive) and English-speaking. * The patient has excessive sleepiness associated with a diagnosis of narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least 4 hours/night on at least 70% of nights), must have documented adequate education and intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy regimen must be stable for at least 4 weeks prior to study entry, and the patient's nCPAP therapy must be effective in the opinion of the investigator. * The patient is in good health as determined by a medical and psychiatric history, clinical laboratory tests, vital signs measurements, electrocardiography (ECG), physical examination, and urine drug screen (UDS) at screening. * If currently receiving therapy for excessive sleepiness associated with their sleep disorder, the patient is dissatisfied because of efficacy and/or safety with their current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for excessive sleepiness associated with their sleep disorder. * The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating at baseline of 4 or more (i.e., at least moderately ill). * Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD). * The patient must be willing and able to comply with study procedures and restrictions, including the completion of self-rating scales, and be willing to return to the study center for visits as specified in this protocol. * The patient may have been prescribed pharmacologic therapy for excessive sleepiness associated with a sleep disorder; however, they must have undergone a washout period of at least 7 days prior to the baseline visit.
Exclusion criteria
Patients are excluded from participating in this study if any of the following criteria are met: * The patient has any treated or untreated clinically significant uncontrolled medical or psychiatric conditions. * The patient has a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of excessive sleepiness. * The patient consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine/day within 1 week of the start of study drug administration. * The patient has a medically unexplainable positive UDS at the screening visit. * The patient has a clinically significant deviation from normal in clinical laboratory test results, vital signs values, or physical examination findings observed at the screening visit. * The patient has used an investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration. * The patient has used any prescription drugs disallowed by the protocol within 7 days before the baseline visit. * The patient has a known or suspected hypersensitivity to armodafinil or any compound present in the study drug or related compounds. * The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from the study). * The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. * The patient 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) within the past 5 years. * The patient has a history of repeated therapeutic failure to therapies for excessive sleepiness. * The patient previously participated in a clinical study with armodafinil.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings | Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn. | A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S. |
Countries
United States
Participant flow
Recruitment details
40 centers in the US. First participant enrolled: 5 October 2005. Last participant last visit: 27 July 2006
Pre-assignment details
1 female participant withdrew for noncompliance after randomization but prior to receiving study drug. The number of participants then analyzed (241) by a PGI-C rating was defined to be those participants who took at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment (5 patients did not meet this requirement).
Participants by arm
| Arm | Count |
|---|---|
| Armodafinil 150 to 250 mg/Day Armodafinil 150 to 250 mg once daily in the morning | 247 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 31 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Miscellaneous | 1 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Armodafinil 150 to 250 mg/Day |
|---|---|
| Age Categorical <=18 years | 0 participants |
| Age Categorical >=65 years | 3 participants |
| Age Categorical Between 18 and 65 years | 243 participants |
| Age Continuous | 46.6 years STANDARD_DEVIATION 12.53 |
| Gender Female | 137 participants |
| Gender Male | 109 participants |
| Region of Enrollment United States | 247 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 134 / 246 |
| serious Total, serious adverse events | 6 / 246 |
Outcome results
Primary
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
Time frame: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Armodafinil 150 to 250 mg/Day | Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings | 241 Participants |
Comparison: This was an open label study, with all patients receiving treatment with armodafinil95% CI: [78.7, 88.1]Descriptive Statistics