Trial · NCT00078377
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
NCT00078377, Phase 3, Completed, Cephalon; results first posted 2010-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy. Trials, record NCT00078377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00078377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
- NCT number
- NCT00078377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- Cephalon
- Conditions
- Narcolepsy
- Interventions
- Armodafinil, Armodafinil, Placebo
- First posted
- 2004-02-26
- Last updated
- 2013-07-19
- Results first posted
- 2010-01-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | change from baseline at 12 weeks | The Maintenance of Wakefulness Test (MWT) 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. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit). |
| Primary | Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | change from baseline at 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 | Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | change from baseline at 12 weeks | Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy. | Minutes | MEAN |
| PRIMARY | Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | change from baseline at 12 weeks | Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | Armodafinil 250 mg/Day | 2.6 | Standard Deviation 6.24 | Minutes | |
| Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | Armodafinil 150 mg/Day | 1.3 | Standard Deviation 6.31 | Minutes | |
| Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | Placebo | -1.9 | Standard Deviation 6.87 | Minutes | |
| Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks | Armodafinil Combined Group (250 mg/Day and 150 mg/Day) | 1.9 | Standard Deviation 6.28 | Minutes | |
| Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | Armodafinil 250 mg/Day | 60 | Participants | ||
| Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | Armodafinil 150 mg/Day | 58 | Participants | ||
| Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | Placebo | 58 | Participants | ||
| Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks | Armodafinil Combined Group (250 mg/Day and 150 mg/Day) | 118 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Armodafinil 250 mg/Day | 67 | |
| Overall Study | STARTED | Armodafinil 150 mg/Day | 65 | |
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | COMPLETED | Armodafinil 250 mg/Day | 56 | |
| Overall Study | COMPLETED | Armodafinil 150 mg/Day | 49 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | Armodafinil 250 mg/Day | 11 | |
| Overall Study | NOT COMPLETED | Armodafinil 150 mg/Day | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events18
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 250 mg/Day | 5 | 67 | |
| other | Nausea | Gastrointestinal disorders | Armodafinil 150 mg/Day | 9 | 64 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Armodafinil 250 mg/Day | 3 | 67 | |
| other | Nasopharyngitis | Infections and infestations | Armodafinil 150 mg/Day | 2 | 64 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 63 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Armodafinil 250 mg/Day | 4 | 67 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Armodafinil 150 mg/Day | 2 | 64 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 0 | 63 | |
| other | Headache | Nervous system disorders | Armodafinil 250 mg/Day | 19 | 67 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Armodafinil 250 mg/Day | ||
| Total, all-cause mortality | Armodafinil 150 mg/Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Armodafinil 250 mg/Day | 29 | 67 |
| Total, other adverse events | Armodafinil 150 mg/Day | 21 | 64 |
| Total, other adverse events | Placebo | 11 | 63 |
| Total, serious adverse events | Armodafinil 250 mg/Day | 0 | 67 |
| Total, serious adverse events | Armodafinil 150 mg/Day | 1 | 64 |
| Total, serious adverse events | Placebo | 0 | 63 |
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/NCT00078377
GET https://conductscience.org/api/trials/v1/NCT00078377/registered