Stopped: Study has been stopped by sponsor decision
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
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Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs
Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study
Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results
Timeframe: Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results
Timeframe: Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results
Timeframe: Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)
Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Number of Participants Answering "Yes" to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)
Timeframe: Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)
Timeframe: Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.