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Trial record 28 of 239 for:    (armodafinil)

Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00983437
Recruitment Status : Terminated (Study has been stopped by sponsor decision)
First Posted : September 24, 2009
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Intervention Drug: Armodafinil
Enrollment 49
Recruitment Details Of patients with excessive sleepiness associated with mild or moderate traumatic brain injury (TBI) who had completed study C10953/3067/ES/MN (NCT00893789) and were considered to be eligible for enrollment into the current study, 49 patients at 25 centers in the United States were enrolled. No new patients were screened for the study.
Pre-assignment Details Of 49 participants enrolled, 2 were withdrawn before taking any study drug for reasons of protocol violation and noncompliance with study procedures, respectively.
Arm/Group Title Armodafinil
Hide Arm/Group Description Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Period Title: Overall Study
Started 47
Safety Analysis Set (SAS) 47 [1]
Full Analysis Set (FAS) 45 [2]
Completed 0 [3]
Not Completed 47
Reason Not Completed
Adverse Event             9
Lack of Efficacy             1
Withdrawal by Subject             8
Noncompliance to Study Procedures             1
Lost to Follow-up             2
Other Reason             26
[1]
Participants who received at least 1 dose of study drug were evaluable for safety.
[2]
Participants had to have at least 1 postbaseline efficacy assessment to be evaluable for efficacy.
[3]
Completed 12 months of treatment with armodafinil.
Arm/Group Title Armodafinil
Hide Arm/Group Description Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
Baseline Analysis Population includes 2 participants who were enrolled but not treated.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
31.1  (10.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
19
  38.8%
Male
30
  61.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants
White 43
Black 3
Asian 2
Other 1
1.Primary Outcome
Title Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs
Hide Description AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789).
Time Frame Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Safety Analysis Set (study participants who received at least 1 dose of study drug)
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Any AE 29
Severe AEs 0
Treatment-related AEs 17
Deaths 0
SAEs (Other Than Deaths) 1
Discontinuations (DCs) Due to AEs 7
Protocol-defined AEs 3
DCs due to AEs with onset during DB phase 2
2.Primary Outcome
Title Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study
Hide Description Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.
Time Frame Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Participants receiving any concomitant medication 39
All other therapeutic products 1
Analgesics 10
Anesthetics 1
Anti-anemic preparations 1
Antibacterials for systemic use 4
Anti-emetics and antinauseants 1
Antigout preparations 1
Antihistamines for systemic use 4
Anti-inflammatory and antirheumatic products 16
Antimycotics for systemic use 1
Antithrombotic agents 1
Beta blocking agents 1
Cardiac therapy 1
Corticosteroids for systemic use 1
Cough and cold preparations 2
Drugs for acid-related disorders 3
Drugs for obstructive airway diseases 3
Drugs used in diabetes 1
General nutrients 1
Lipid-modifying agents 11
Nasal preparations 4
Other gynecologicals 2
Psychoanaleptics 1
Psycholeptics 2
Sex hormones and modulators of the genital system 7
Thyroid therapy 1
Unspecified herbal 4
Vitamins 12
3.Primary Outcome
Title Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results
Hide Description Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L.
Time Frame Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
Participants with at least 1 abnormality (overall) 3
Blood Urea Nitrogen >=10.71 2
Uric Acid >=625 (male) or >=506 (female) µmol/L 1
4.Primary Outcome
Title Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements
Hide Description Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame 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.
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
0
5.Primary Outcome
Title Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results
Hide Description Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L.
Time Frame Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
0
6.Primary Outcome
Title Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results
Hide Description Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
0
7.Primary Outcome
Title Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria
Hide Description Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame 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.
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Hide Analysis Population Description
Safety Analysis Set; participants with a baseline and postbaseline value.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
Participants with at least 1 notable BP value 6
Sitting systolic BP >=140 mm Hg + Increase >=10% 4
Sitting diastolic BP >=90 mm Hg + Increase >=10% 3
8.Primary Outcome
Title Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall
Hide Description Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Normal at BL → Normal Overall 17
Normal at BL→ Abnormal Overall 4
Abnormal at BL→ Normal Overall 3
Abnormal at BL → Abnormal Overall 11
9.Primary Outcome
Title Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
General Appearance: Normal at BL→Normal at EP 37
General Appearance: Normal at BL→ Abnormal at EP 2
General Appearance: Abnormal at BL→ Normal at EP 0
General Appearance: Abnormal at BL→Abnormal at EP 0
HEENT: Normal at BL→Normal at EP 37
HEENT: Normal at BL→Abnormal at EP 1
HEENT: Abnormal at BL→Normal at EP 1
HEENT: Abnormal at BL→Abnormal at EP 0
Chest/Lungs: Normal at BL→Normal at EP 39
Chest/Lungs: Normal at BL→Abnormal at EP 0
Chest/Lungs: Abnormal at BL→Normal at EP 0
Chest/Lungs: Abnormal at BL→Abnormal at EP 0
Heart: Normal at BL→Normal at EP 38
Heart: Normal at BL→Abnormal at EP 1
Heart: Abnormal at BL→Normal at EP 0
Heart: Abnormal at BL→Abnormal at EP 0
Abdomen: Normal at BL→Normal at EP 38
Abdomen: Normal at BL→Abnormal at EP 1
Abdomen: Abnormal at BL→Normal at EP 0
Abdomen: Abnormal at BL→Abnormal at EP 0
Musculoskeletal: Normal at BL→Normal at EP 38
Musculoskeletal: Normal at BL→Abnormal at EP 1
Musculoskeletal: Abnormal at BL→Normal at EP 0
Musculoskeletal: Abnormal at BL→Abnormal at EP 0
Skin: Normal at BL→Normal at EP 35
Skin: Normal at BL→Abnormal at EP 0
Skin: Abnormal at BL→Normal at EP 0
Skin: Abnormal at BL→Abnormal at EP 4
Lymph Nodes: Normal at BL→Normal at EP 34
Lymph Nodes: Normal at BL→Abnormal at EP 0
Lymph Nodes: Abnormal at BL→Normal at EP 1
Lymph Nodes: Abnormal at BL→Abnormal at EP 0
Neurological: Normal at BL→Normal at EP 37
Neurological: Normal at BL→Abnormal at EP 1
Neurological: Abnormal at BL→Normal at EP 1
Neurological: Abnormal at BL→Abnormal at EP 0
10.Primary Outcome
Title 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)
Hide Description The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.
Time Frame 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.
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Hide Analysis Population Description
Safety Analysis Set; n=number of participants with nonmissing value at given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Week 2 (n=18), yes to any question 0
Month 1 (n=18), yes to any question 0
Month 2 (n=18), yes to any question 0
Month 3 (n=13), yes to any question 0
Month 6 (n=10), yes to any question 0
Month 9 (n=4), yes to any question 0
Endpoint (n=36), yes to 'Wish to Be Dead' question 1
Endpoint (n=36), yes to all other questions 0
11.Primary Outcome
Title 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)
Hide Description The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame 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.
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Hide Analysis Population Description
Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=13) 1.4  (1.33)
Change from BL at Week 2 (n=13) 0.9  (3.43)
Change from BL at Month 1 (n=12) 0.2  (2.41)
Change from BL at Month 2 (n=9) 0.0  (2.35)
Change from BL at Month 3 (n=1) -1.0 [1]   (NA)
Change from BL at Month 6 (n=0) NA [2]   (NA)
Change from BL at Month 9 (n=0) NA [2]   (NA)
Change from BL at Endpoint (n=13) 0.0  (2.65)
[1]
Only 1 participant measured.
[2]
No participants had available measurements at this time point.
12.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline, Week 2 and 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.
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Hide Analysis Population Description
Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=45) 14.8  (2.60)
Change from BL at Week 2 (n=41) -8.0  (4.42)
Change from BL at Month 1 (n=35) -8.5  (4.37)
Change from BL at Month 2 (n=30) -9.0  (3.56)
Change from BL at Month 3 (n=22) -9.0  (3.53)
Change from BL at Month 6 (n=11) -10.0  (3.26)
Change from BL at Month 9 (n=4) -10.3  (4.79)
Change from BL at Endpoint (n=45) -9.0  (4.48)
13.Secondary Outcome
Title Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline, Week 2 and 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=45) 4.4  (0.53)
Change from BL at Week 2 (n=41) -1.9  (1.04)
Change from BL at Month 1 (n=35) -2.1  (1.09)
Change from BL at Month 2 (n=30) -2.6  (0.81)
Change from BL at Month 3 (n=22) -2.4  (0.73)
Change from BL at Month 6 (n=11) -2.5  (1.29)
Change from BL at Month 9 (n=4) -3.3  (0.96)
Change from BL at Endpoint (n=45) -2.2  (1.15)
14.Secondary Outcome
Title Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Week 2 and 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
Improved at Week 2 (n=41) 95
Not Improved at Week 2 (n=41) 5
Improved at Month 1 (n=35) 97
Not Improved at Month 1 (n=35) 3
Improved at Month 2 (n=30) 100
Not Improved at Month 2 (n=30) 0
Improved at Month 3 (n=22) 100
Not Improved at Month 3 (n=22) 0
Improved at Month 6 (n=11) 91
Not Improved at Month 6 (n=11) 9
Improved at Month 9 (n=4) 100
Not Improved at Month 9 (n=4) 0
Improved at Endpoint (n=45) 93
Not Improved at Endpoint (n=45) 7
15.Secondary Outcome
Title Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a "true" or "not true" answer. To score the questionnaire, the number of "true" responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.
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Hide Analysis Population Description
Participants in the Full Analysis Set (those in the Safety Analysis Set with at least 1 post-baseline efficacy assessment) with a TBI-WIS score at baseline; n=number of participants with value at baseline and given time point.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (BL; n=34) 9.6  (6.93)
Change from BL at Month 3 (n=19) -3.1  (5.87)
Change from BL at Month 6 (n=10) -2.5  (7.32)
Change from BL at Month 9 (n=3) -7.3  (2.52)
Change from BL at Endpoint (n=34) -4.6  (6.52)
16.Secondary Outcome
Title Change From Baseline in the Medical Outcomes Study 6-Item Cognitive Functioning Scale (MOS-CF6) Total Score at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)
Hide Description The MOS-CF 6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6-item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 is scored by summing responses across the 6 items and converting the total to a 0- to 100-point scale, with higher scores indicating better cognitive functioning. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.
Time Frame Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)
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Hide Analysis Population Description
Changes from baseline in MOS-CF6 total score were not summarized. This assessment was not performed in study C10953/3067/ES/MN (NCT00893789); therefore, the data obtained at screening for the current study would represent true baseline data only for new participants, of which there were none.
Arm/Group Title Armodafinil
Hide Arm/Group Description:
Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil
Hide Arm/Group Description Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
All-Cause Mortality
Armodafinil
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil
Affected / at Risk (%)
Total   1/47 (2.13%) 
Psychiatric disorders   
Psychotic Disorder  1  1/47 (2.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Armodafinil
Affected / at Risk (%)
Total   29/47 (61.70%) 
Gastrointestinal disorders   
Nausea  1  3/47 (6.38%) 
Dry mouth  1  2/47 (4.26%) 
General disorders   
Feeling jittery  1  2/47 (4.26%) 
Infections and infestations   
Upper respiratory tract infection  1  4/47 (8.51%) 
Injury, poisoning and procedural complications   
Muscle strain  1  2/47 (4.26%) 
Investigations   
Weight decreased  1  2/47 (4.26%) 
Musculoskeletal and connective tissue disorders   
Muscle tightness  1  2/47 (4.26%) 
Pain in extremity  1  2/47 (4.26%) 
Nervous system disorders   
Headache  1  7/47 (14.89%) 
Psychiatric disorders   
Insomnia  1  3/47 (6.38%) 
Anxiety  1  2/47 (4.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
The sponsor’s decision to terminate the study early resulted in the small number of study participants, and related limitations to the interpretation of the study results.
Certain Agreements
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00983437     History of Changes
Other Study ID Numbers: C10953/3069/ES/MN
First Submitted: September 9, 2009
First Posted: September 24, 2009
Results First Submitted: May 9, 2013
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013