Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00078377
First received: February 24, 2004
Last updated: December 17, 2009
Last verified: December 2009
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Results First Received: June 1, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment |
| Condition: |
Narcolepsy |
| Interventions: |
Drug: Armodafinil Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 47 centers in the US, Canada, France, Germany, Russia, and Australia. First patient enrolled (treatment): 23 March 2004/ Last patient last visit: 10 January 2005 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up) |
Reporting Groups
| Description | |
|---|---|
| Armodafinil 250 mg/Day | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| Placebo | Matching placebo tablets once daily in the morning |
Participant Flow: Overall Study
| Armodafinil 250 mg/Day | Armodafinil 150 mg/Day | Placebo | |
|---|---|---|---|
| STARTED | 67 | 65 | 64 |
| COMPLETED | 56 | 49 | 55 |
| NOT COMPLETED | 11 | 16 | 9 |
| Adverse Event | 2 | 5 | 1 |
| Lack of Efficacy | 2 | 0 | 2 |
| Lost to Follow-up | 0 | 1 | 1 |
| Physician Decision | 2 | 0 | 0 |
| Withdrawal by Subject | 3 | 4 | 4 |
| Miscellaneous | 2 | 6 | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Armodafinil 250 mg/Day | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| Placebo | Matching placebo tablets once daily in the morning |
| Total | Total of all reporting groups |
Baseline Measures
| Armodafinil 250 mg/Day | Armodafinil 150 mg/Day | Placebo | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
67 | 65 | 64 | 196 |
|
Age
[1] [units: participants] |
||||
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 66 | 64 | 63 | 193 |
| >=65 years | 1 | 0 | 0 | 1 |
|
Age
[units: years] Mean ± Standard Deviation |
35.0 ± 12.52 | 40.4 ± 12.52 | 39.2 ± 11.98 | 38.1 ± 12.50 |
|
Gender
[1] [units: participants] |
||||
| Female | 42 | 36 | 31 | 109 |
| Male | 25 | 28 | 32 | 85 |
|
Region of Enrollment
[units: participants] |
||||
| United States | 37 | 37 | 37 | 111 |
| Canada | 12 | 12 | 12 | 36 |
| France | 3 | 3 | 3 | 9 |
| Germany | 5 | 4 | 4 | 13 |
| Russian Federation | 5 | 4 | 4 | 13 |
| Australia | 5 | 5 | 4 | 14 |
| [1] | 2 female patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up) |
|---|
Outcome Measures
| 1. Primary: | Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks [ Time Frame: change from baseline at 12 weeks ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks |
| Measure Description | 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). |
| Time Frame | change from baseline at 12 weeks |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
|
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. |
Reporting Groups
| Description | |
|---|---|
| Armodafinil 250 mg/Day | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| Placebo | Matching placebo tablets once daily in the morning |
| Armodafinil Combined Group (250 mg/Day and 150 mg/Day) | No text entered. |
Measured Values
| Armodafinil 250 mg/Day | Armodafinil 150 mg/Day | Placebo | Armodafinil Combined Group (250 mg/Day and 150 mg/Day) | |
|---|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
60 | 58 | 58 | 118 |
|
Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
[units: Minutes] Mean ± Standard Deviation |
2.6 ± 6.24 | 1.3 ± 6.31 | -1.9 ± 6.87 | 1.9 ± 6.28 |
Statistical Analysis 1 for Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
| Groups [1] | Armodafinil 250 mg/Day vs. Armodafinil 150 mg/Day vs. Placebo |
|---|---|
| Method [2] | ANCOVA |
| P Value [3] | 0.0024 |
| Mean Difference (Final Values) [4] | 3.8 |
| 95% Confidence Interval | ( 1.02 to 4.61 ) |
| [1] | Additional details about the analysis, such as null hypothesis and power calculation: |
|---|---|
| Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group | |
| [2] | Other relevant information, such as adjustments or degrees of freedom: |
| The corresponding baseline value as a covariate. | |
| [3] | Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: |
| No text entered. | |
| [4] | Other relevant estimation information: |
| No text entered. |
| 2. Primary: | Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks [ Time Frame: change from baseline at 12 weeks ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Sponsor's Medical Director, Clinical Research
Organization: Cephalon, Inc.
phone: 1-877-237-4879
Organization: Cephalon, Inc.
phone: 1-877-237-4879
No publications provided
| ClinicalTrials.gov Identifier: | NCT00078377 History of Changes |
| Other Study ID Numbers: | C10953/3020/NA/MN |
| Study First Received: | February 24, 2004 |
| Results First Received: | June 1, 2009 |
| Last Updated: | December 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |