Trial Outcomes & Findings for 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 (NCT NCT00983437)

Last Updated: 2021-12-17

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Results posted on

2021-12-17

Participant Flow

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.

Of 49 participants enrolled, 2 were withdrawn before taking any study drug for reasons of protocol violation and noncompliance with study procedures, respectively.

Participant milestones

Participant milestones
Measure	Armodafinil Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Study STARTED	47
Overall Study Safety Analysis Set (SAS)	47
Overall Study Full Analysis Set (FAS)	45
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Overall Study Adverse Event	9
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	8
Overall Study Noncompliance to Study Procedures	1
Overall Study Lost to Follow-up	2
Overall Study Other Reason	26

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil n=49 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Age, Continuous	31.1 years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized White	43 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Population: Safety Analysis Set (study participants who received at least 1 dose of study drug)

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Any AE	29 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Severe AEs	0 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Treatment-related AEs	17 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Deaths	0 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs SAEs (Other Than Deaths)	1 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Discontinuations (DCs) Due to AEs	7 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs Protocol-defined AEs	3 participants
Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs DCs due to AEs with onset during DB phase	2 participants

PRIMARY outcome

Timeframe: Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Population: Safety Analysis Set

Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Antithrombotic agents	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Vitamins	12 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Participants receiving any concomitant medication	39 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study All other therapeutic products	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Analgesics	10 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Anesthetics	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Anti-anemic preparations	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Antibacterials for systemic use	4 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Anti-emetics and antinauseants	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Antigout preparations	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Antihistamines for systemic use	4 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Anti-inflammatory and antirheumatic products	16 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Antimycotics for systemic use	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Beta blocking agents	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Cardiac therapy	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Corticosteroids for systemic use	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Cough and cold preparations	2 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Drugs for acid-related disorders	3 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Drugs for obstructive airway diseases	3 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Drugs used in diabetes	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study General nutrients	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Lipid-modifying agents	11 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Nasal preparations	4 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Other gynecologicals	2 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Psychoanaleptics	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Psycholeptics	2 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Sex hormones and modulators of the genital system	7 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Thyroid therapy	1 participants
Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study Unspecified herbal	4 participants

PRIMARY outcome

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.

Population: Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=38 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results Participants with at least 1 abnormality (overall)	3 participants
Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results Blood Urea Nitrogen >=10.71	2 participants
Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results Uric Acid >=625 (male) or >=506 (female) µmol/L	1 participants

PRIMARY outcome

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.

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements	0 participants

PRIMARY outcome

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.

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results	0 participants

PRIMARY outcome

Timeframe: Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Population: Safety Analysis Set

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results	0 participants

PRIMARY outcome

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.

Population: Safety Analysis Set; participants with a baseline and postbaseline value.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=45 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria Participants with at least 1 notable BP value	6 participants
Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria Sitting systolic BP >=140 mm Hg + Increase >=10%	4 participants
Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria Sitting diastolic BP >=90 mm Hg + Increase >=10%	3 participants

PRIMARY outcome

Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Population: Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=35 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall Normal at BL → Normal Overall	17 participants
Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall Normal at BL→ Abnormal Overall	4 participants
Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall Abnormal at BL→ Normal Overall	3 participants
Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall Abnormal at BL → Abnormal Overall	11 participants

PRIMARY outcome

Timeframe: Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.

Population: Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=39 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Lymph Nodes: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) General Appearance: Normal at BL→Normal at EP	37 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) General Appearance: Normal at BL→ Abnormal at EP	2 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) General Appearance: Abnormal at BL→ Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) General Appearance: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) HEENT: Normal at BL→Normal at EP	37 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) HEENT: Normal at BL→Abnormal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) HEENT: Abnormal at BL→Normal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) HEENT: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Chest/Lungs: Normal at BL→Normal at EP	39 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Chest/Lungs: Normal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Chest/Lungs: Abnormal at BL→Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Chest/Lungs: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Heart: Normal at BL→Normal at EP	38 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Heart: Normal at BL→Abnormal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Heart: Abnormal at BL→Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Heart: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Abdomen: Normal at BL→Normal at EP	38 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Abdomen: Normal at BL→Abnormal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Abdomen: Abnormal at BL→Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Abdomen: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Musculoskeletal: Normal at BL→Normal at EP	38 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Musculoskeletal: Normal at BL→Abnormal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Musculoskeletal: Abnormal at BL→Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Musculoskeletal: Abnormal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Skin: Normal at BL→Normal at EP	35 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Skin: Normal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Skin: Abnormal at BL→Normal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Skin: Abnormal at BL→Abnormal at EP	4 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Lymph Nodes: Normal at BL→Normal at EP	34 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Lymph Nodes: Normal at BL→Abnormal at EP	0 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Lymph Nodes: Abnormal at BL→Normal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Neurological: Normal at BL→Normal at EP	37 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Neurological: Normal at BL→Abnormal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Neurological: Abnormal at BL→Normal at EP	1 participants
Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation) Neurological: Abnormal at BL→Abnormal at EP	0 participants

PRIMARY outcome

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.

Population: Safety Analysis Set; n=number of participants with nonmissing value at given time point.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=47 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Month 6 (n=10), yes to any question	0 participants
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) Month 3 (n=13), yes to any question	0 participants
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) Month 9 (n=4), yes to any question	0 participants
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) Endpoint (n=36), yes to 'Wish to Be Dead' question	1 participants
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) Endpoint (n=36), yes to all other questions	0 participants
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) Week 2 (n=18), yes to any question	0 participants
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) Month 1 (n=18), yes to any question	0 participants
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) Month 2 (n=18), yes to any question	0 participants

PRIMARY outcome

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.

Population: Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=13 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Change from BL at Month 2 (n=9)	0.0 units on a scale Standard Deviation 2.35
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) Baseline (BL; n=13)	1.4 units on a scale Standard Deviation 1.33
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) Change from BL at Week 2 (n=13)	0.9 units on a scale Standard Deviation 3.43
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) Change from BL at Month 1 (n=12)	0.2 units on a scale Standard Deviation 2.41
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) Change from BL at Month 3 (n=1)	-1.0 units on a scale Standard Deviation NA Only 1 participant measured.
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) Change from BL at Month 6 (n=0)	NA units on a scale Standard Deviation NA No participants had available measurements at this time point.
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) Change from BL at Month 9 (n=0)	NA units on a scale Standard Deviation NA No participants had available measurements at this time point.
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) Change from BL at Endpoint (n=13)	0.0 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=45 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Baseline (BL; n=45)	14.8 units on a scale Standard Deviation 2.60
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) Change from BL at Week 2 (n=41)	-8.0 units on a scale Standard Deviation 4.42
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) Change from BL at Month 1 (n=35)	-8.5 units on a scale Standard Deviation 4.37
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) Change from BL at Month 2 (n=30)	-9.0 units on a scale Standard Deviation 3.56
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) Change from BL at Month 3 (n=22)	-9.0 units on a scale Standard Deviation 3.53
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) Change from BL at Month 6 (n=11)	-10.0 units on a scale Standard Deviation 3.26
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) Change from BL at Month 9 (n=4)	-10.3 units on a scale Standard Deviation 4.79
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) Change from BL at Endpoint (n=45)	-9.0 units on a scale Standard Deviation 4.48

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=45 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Baseline (BL; n=45)	4.4 units on a scale Standard Deviation 0.53
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) Change from BL at Week 2 (n=41)	-1.9 units on a scale Standard Deviation 1.04
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) Change from BL at Month 1 (n=35)	-2.1 units on a scale Standard Deviation 1.09
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) Change from BL at Month 2 (n=30)	-2.6 units on a scale Standard Deviation 0.81
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) Change from BL at Month 3 (n=22)	-2.4 units on a scale Standard Deviation 0.73
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) Change from BL at Month 6 (n=11)	-2.5 units on a scale Standard Deviation 1.29
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) Change from BL at Month 9 (n=4)	-3.3 units on a scale Standard Deviation 0.96
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) Change from BL at Endpoint (n=45)	-2.2 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=45 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Improved at Week 2 (n=41)	95 percentage of participants
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) Not Improved at Week 2 (n=41)	5 percentage of participants
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) Improved at Month 1 (n=35)	97 percentage of participants
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) Not Improved at Month 1 (n=35)	3 percentage of participants
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) Improved at Month 2 (n=30)	100 percentage of participants
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) Not Improved at Month 2 (n=30)	0 percentage of participants
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) Improved at Month 3 (n=22)	100 percentage of participants
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) Not Improved at Month 3 (n=22)	0 percentage of participants
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) Improved at Month 6 (n=11)	91 percentage of participants
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) Not Improved at Month 6 (n=11)	9 percentage of participants
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) Improved at Month 9 (n=4)	100 percentage of participants
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) Not Improved at Month 9 (n=4)	0 percentage of participants
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) Improved at Endpoint (n=45)	93 percentage of participants
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) Not Improved at Endpoint (n=45)	7 percentage of participants

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Armodafinil n=34 Participants Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
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) Baseline (BL; n=34)	9.6 units on a scale Standard Deviation 6.93
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) Change from BL at Month 3 (n=19)	-3.1 units on a scale Standard Deviation 5.87
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) Change from BL at Month 6 (n=10)	-2.5 units on a scale Standard Deviation 7.32
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) Change from BL at Month 9 (n=3)	-7.3 units on a scale Standard Deviation 2.52
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) Change from BL at Endpoint (n=34)	-4.6 units on a scale Standard Deviation 6.52

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Armodafinil

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil n=47 participants at risk Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Psychiatric disorders Psychotic Disorder	2.1% 1/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Other adverse events

Other adverse events
Measure	Armodafinil n=47 participants at risk Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
Gastrointestinal disorders Nausea	6.4% 3/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Gastrointestinal disorders Dry mouth	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
General disorders Feeling jittery	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Infections and infestations Upper respiratory tract infection	8.5% 4/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Injury, poisoning and procedural complications Muscle strain	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Investigations Weight decreased	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Musculoskeletal and connective tissue disorders Muscle tightness	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Nervous system disorders Headache	14.9% 7/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Psychiatric disorders Insomnia	6.4% 3/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.
Psychiatric disorders Anxiety	4.3% 2/47 • From Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER