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Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

Primary Purpose

Excessive Sleepiness, Shift Work Sleep Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Armodafinil 150 mg/day
Placebo
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Excessive Sleepiness focused on measuring Excessive Sleepiness, Chronic Shift Work Sleep Disorder, Chronic SWSD, Circadian Rhythm Disorder, Shift Worker, Cephalon, Cephalon, Inc, Nuvigil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 diagnosis of SWSD according to International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months. The patient must work at least 5 night shifts per month, of which at least 3 nights are consecutive, and plan to maintain this schedule. The patient must work night shifts that include at least 6 hours between 2200 and 0800 and be no longer than 12 hours in duration. The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. 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, or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. Steroidal contraceptives must be used with a barrier method while taking the study drug and for at least a full cycle after discontinuation of the study drug. The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT The patient has a CGI-S rating as it pertains to sleepiness during night shifts including the commute to and from work. The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness during the night shift. 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. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) has a probable diagnosis of a current sleep disorder other than SWSD consumes 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 screening/baseline 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 urine drug screen (UDS) at the screening visit 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Armodafinil 150 mg/day

    Placebo

    Outcomes

    Primary Outcome Measures

    Multiple Sleep Latency Test (MSLT)
    The Multiple Sleep Latency Test (MSLT) 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. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).
    Clinical Global Impression of Change (CGI-C)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 25, 2004
    Last Updated
    July 12, 2013
    Sponsor
    Cephalon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00080288
    Brief Title
    Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
    Official Title
    A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cephalon

    4. Oversight

    5. Study Description

    Brief Summary
    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 chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Excessive Sleepiness, Shift Work Sleep Disorder
    Keywords
    Excessive Sleepiness, Chronic Shift Work Sleep Disorder, Chronic SWSD, Circadian Rhythm Disorder, Shift Worker, Cephalon, Cephalon, Inc, Nuvigil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    254 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Armodafinil 150 mg/day
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Armodafinil 150 mg/day
    Intervention Description
    Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablets once daily
    Primary Outcome Measure Information:
    Title
    Multiple Sleep Latency Test (MSLT)
    Description
    The Multiple Sleep Latency Test (MSLT) 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. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).
    Time Frame
    up to 12 weeks
    Title
    Clinical Global Impression of Change (CGI-C)
    Description
    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.
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 diagnosis of SWSD according to International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months. The patient must work at least 5 night shifts per month, of which at least 3 nights are consecutive, and plan to maintain this schedule. The patient must work night shifts that include at least 6 hours between 2200 and 0800 and be no longer than 12 hours in duration. The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. 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, or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. Steroidal contraceptives must be used with a barrier method while taking the study drug and for at least a full cycle after discontinuation of the study drug. The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT The patient has a CGI-S rating as it pertains to sleepiness during night shifts including the commute to and from work. The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness during the night shift. 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. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) has a probable diagnosis of a current sleep disorder other than SWSD consumes 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 screening/baseline 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 urine drug screen (UDS) at the screening visit 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19880686
    Citation
    Czeisler CA, Walsh JK, Wesnes KA, Arora S, Roth T. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009 Nov;84(11):958-72. doi: 10.1016/S0025-6196(11)60666-6.
    Results Reference
    derived

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    Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

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