Trial · NCT00228553
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
NCT00228553, Phase 3, Completed, Cephalon; results first posted 2010-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness. Trials, record NCT00228553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00228553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
- NCT number
- NCT00228553
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 743 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Interventions
- Armodafinil 100 to 250 mg/day
- First posted
- 2005-09-29
- Last updated
- 2013-07-19
- Results first posted
- 2010-03-31
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) | Armodafinil 100 to 250 mg/Day | 667 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Armodafinil 100 to 250 mg/Day | 743 | |
| Overall Study | COMPLETED | Armodafinil 100 to 250 mg/Day | 313 | |
| Overall Study | NOT COMPLETED | Armodafinil 100 to 250 mg/Day | 430 |
Source ClinicalTrials.gov
Adverse events87
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 100 to 250 mg/Day | 68 | 731 | |
| other | Dry mouth | Gastrointestinal disorders | Armodafinil 100 to 250 mg/Day | 49 | 731 | |
| other | Diarrhoea | Gastrointestinal disorders | Armodafinil 100 to 250 mg/Day | 39 | 731 | |
| other | Nasopharyngitis | Infections and infestations | Armodafinil 100 to 250 mg/Day | 123 | 731 | |
| other | Upper respiratory tract infection | Infections and infestations | Armodafinil 100 to 250 mg/Day | 76 | 731 | |
| other | Sinusitis | Infections and infestations | Armodafinil 100 to 250 mg/Day | 64 | 731 | |
| other | Influenza | Infections and infestations | Armodafinil 100 to 250 mg/Day | 55 | 731 | |
| other | Bronchitis | Infections and infestations | Armodafinil 100 to 250 mg/Day | 37 | 731 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Armodafinil 100 to 250 mg/Day | 59 | 731 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Armodafinil 100 to 250 mg/Day | 53 | 731 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 100 to 250 mg/Day | ||
| Total, other adverse events | Armodafinil 100 to 250 mg/Day | 667 | 731 |
| Total, serious adverse events | Armodafinil 100 to 250 mg/Day | 56 | 731 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00228553
GET https://conductscience.org/api/trials/v1/NCT00228553/events?page=2