Trial · NCT00228566
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
NCT00228566, Phase 3, Completed, Cephalon; results first posted 2010-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome. Trials, record NCT00228566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00228566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
- NCT number
- NCT00228566
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 247 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Interventions
- Armodafinil
- First posted
- 2005-09-29
- Last updated
- 2013-07-19
- Results first posted
- 2010-06-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.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. |
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 | 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. | 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 |
|---|---|---|---|---|---|
| Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings | Armodafinil 150 to 250 mg/Day | 241 | 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 150 to 250 mg/Day | 247 | |
| Overall Study | COMPLETED | Armodafinil 150 to 250 mg/Day | 176 | |
| Overall Study | NOT COMPLETED | Armodafinil 150 to 250 mg/Day | 71 |
Source ClinicalTrials.gov
Adverse events17
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 to 250 mg/Day | 30 | 246 | |
| other | Dry mouth | Gastrointestinal disorders | Armodafinil 150 to 250 mg/Day | 22 | 246 | |
| other | Diarrhoea | Gastrointestinal disorders | Armodafinil 150 to 250 mg/Day | 13 | 246 | |
| other | Nasopharyngitis | Infections and infestations | Armodafinil 150 to 250 mg/Day | 35 | 246 | |
| other | Upper respiratory tract infection | Infections and infestations | Armodafinil 150 to 250 mg/Day | 21 | 246 | |
| other | Headache | Nervous system disorders | Armodafinil 150 to 250 mg/Day | 50 | 246 | |
| other | Dizziness | Nervous system disorders | Armodafinil 150 to 250 mg/Day | 14 | 246 | |
| other | Anxiety | Psychiatric disorders | Armodafinil 150 to 250 mg/Day | 16 | 246 | |
| other | Insomnia | Psychiatric disorders | Armodafinil 150 to 250 mg/Day | 15 | 246 | |
| serious | Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Armodafinil 150 to 250 mg/Day | 1 | 246 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 150 to 250 mg/Day | ||
| Total, other adverse events | Armodafinil 150 to 250 mg/Day | 134 | 246 |
| Total, serious adverse events | Armodafinil 150 to 250 mg/Day | 6 | 246 |
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/NCT00228566
GET https://conductscience.org/api/trials/v1/NCT00228566/registered