Trial · NCT00080288
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
NCT00080288, Phase 3, Completed, Cephalon; results first posted 2009-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD. Trials, record NCT00080288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00080288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
- NCT number
- NCT00080288
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 254 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Excessive Sleepiness, Shift Work Sleep Disorder
- Interventions
- Armodafinil 150 mg/day, Placebo
- First posted
- 2004-03-29
- Last updated
- 2013-07-19
- Results first posted
- 2009-09-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Multiple Sleep Latency Test (MSLT) | up to 12 weeks | 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). |
| Primary | Clinical Global Impression of Change (CGI-C) | up to 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Multiple Sleep Latency Test (MSLT) | up to 12 weeks | Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy. | Minutes | MEAN |
| PRIMARY | Clinical Global Impression of Change (CGI-C) | up to 12 weeks | Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Multiple Sleep Latency Test (MSLT) | Armodafinil 150 mg/Day | 3.1 | Standard Deviation 4.46 | Minutes | |
| Multiple Sleep Latency Test (MSLT) | Placebo | 0.4 | Standard Deviation 2.87 | Minutes | |
| Clinical Global Impression of Change (CGI-C) | Armodafinil 150 mg/Day | 112 | Participants | ||
| Clinical Global Impression of Change (CGI-C) | Placebo | 104 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Armodafinil 150 mg/Day | 127 | |
| Overall Study | STARTED | Placebo | 127 | |
| Overall Study | COMPLETED | Armodafinil 150 mg/Day | 97 | |
| Overall Study | COMPLETED | Placebo | 89 | |
| Overall Study | NOT COMPLETED | Armodafinil 150 mg/Day | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 38 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Armodafinil 150 mg/Day | 9 | 123 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 122 | |
| other | Nasopharyngitis | Infections and infestations | Armodafinil 150 mg/Day | 7 | 123 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 4 | 122 | |
| other | Headache | Nervous system disorders | Armodafinil 150 mg/Day | 15 | 123 | |
| other | Headache | Nervous system disorders | Placebo | 12 | 122 | |
| serious | Meningitis viral | Infections and infestations | Armodafinil 150 mg/Day | 1 | 123 | |
| serious | Meningitis viral | Infections and infestations | Placebo | 0 | 122 | |
| serious | Depression suicidal | Psychiatric disorders | Armodafinil 150 mg/Day | 0 | 123 | |
| serious | Depression suicidal | Psychiatric disorders | Placebo | 1 | 122 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 150 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Armodafinil 150 mg/Day | 28 | 123 |
| Total, other adverse events | Placebo | 18 | 122 |
| Total, serious adverse events | Armodafinil 150 mg/Day | 1 | 123 |
| Total, serious adverse events | Placebo | 1 | 122 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19880686 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Armodafinil 150 mg/Day vs Placebo: Clinical Global Impression of Change (CGI-C) | Trial comparisons |
| Armodafinil 150 mg/Day vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00080288
GET https://conductscience.org/api/trials/v1/NCT00080288/registered