Phase 3
N=427
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Excessive Sleepiness
Bottom Line
View on ClinicalTrials.gov: NCT00758498 ↗Enrolled (actual)
427
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 — 7.7; 11.7; 4.8 Minutes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- armodafinil (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cephalon
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2 |
7.7; 11.7; 4.8 | <0.0001 sig |
| PRIMARY Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2 |
1.9; 1.6; 1.9 | 0.8341 |
| SECONDARY Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS) |
4.8; 4.3; 5.5 | <0.0001 sig |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1 |
5.7; 4.8; 6.3 | 0.0012 sig |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2 |
4.0; 3.8; 4.7 | <0.0001 sig |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3 |
3.6; 3.6; 4.0 | 0.0022 sig |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline |
4.0; 4.0; 3.8 | — |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1 |
7.2; 6.9; 7.1 | — |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2 |
5.2; 5.2; 5.0 | — |
| SECONDARY Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3 |
3.6; 3.9; 3.5 | — |
| SECONDARY Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline |
15.2; 15.3; 15.0 | — |
| SECONDARY Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1 |
5.6; 9.6; 3.4 | <0.0001 sig |
| SECONDARY Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2 |
9.9; 13.8; 6.2 | <0.0001 sig |
| SECONDARY Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3 |
12.1; 14.8; 8.3 | <0.0001 sig |
| SECONDARY Mean Patient Global Impression of Severity of General Condition Ratings at Baseline |
1.0; 1.0; 1.0 | — |
| SECONDARY Mean Patient Global Impression of Severity of General Condition Ratings at Day 1 |
2.2; 1.7; 2.1 | 0.8262 |
| SECONDARY Mean Patient Global Impression of Severity of General Condition Ratings at Day 2 |
1.6; 1.5; 1.6 | 0.9595 |
| SECONDARY Mean Patient Global Impression of Severity of General Condition Ratings at Day 3 |
1.2; 1.4; 1.4 | 0.1038 |
| SECONDARY Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint |
0.0; 1.6; 0.6 | — |
| SECONDARY Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1 |
3.8; 4.3; 4.3 | — |
| SECONDARY Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2 |
1.5; 2.8; 1.3 | — |
| SECONDARY Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3 |
-0.1; 1.6; 0.2 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography |
-10.0; -30.5; -5.2 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography |
-12.9; -0.8; -11.0 | — |
| SECONDARY Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography |
-2.1; -6.3; -1.1 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography |
20.0; 30.4; 14.4 | — |
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
Eligibility Criteria
Key Inclusion Criteria
- History of jet lag symptoms during the past 5 years.
- The subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ECG) and physical examination findings.
- Women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study).
- The subject is willing to comply with study restrictions and remain at the study center overnight, as required.
- The subject must agree to refrain from alcohol use during the study.
- The subject has a valid U.S. passport
Key Exclusion Criteria
- The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder.
- The subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant significant medical condition.
- The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hypersensitivity reaction, or multiple allergies.
- The subject has a history of deep vein thrombosis (DVT).
- The subject has known human immunodeficiency virus (HIV).
- The subject is pregnant or lactating.
- The subject has used nicotine within the last 3 months.
- The subject has a history of seizures, except for a single febrile seizure.
- The subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures.
- The subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings.
- The subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics).
- The subject has used an investigational drug within 1 month before the screening visit.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
Data sourced from ClinicalTrials.gov (NCT00758498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.