Trial Outcomes & Findings for Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness (NCT NCT00228553)
NCT ID: NCT00228553
Last Updated: 2013-07-19
Results Overview
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
743 participants
Primary outcome timeframe
End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
Results posted on
2013-07-19
Participant Flow
99 centers in the US, Canada, France, Germany, Russia, and Australia. First participant enrolled: 15 May 2004/ Last participant last visit: 19 July 2006
12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
Participant milestones
| Measure |
Armodafinil 100 to 250 mg/Day
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Overall Study
STARTED
|
743
|
|
Overall Study
COMPLETED
|
313
|
|
Overall Study
NOT COMPLETED
|
430
|
Reasons for withdrawal
| Measure |
Armodafinil 100 to 250 mg/Day
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Overall Study
Adverse Event
|
112
|
|
Overall Study
Lack of Efficacy
|
34
|
|
Overall Study
Lost to Follow-up
|
67
|
|
Overall Study
Physician Decision
|
48
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Withdrawal by Subject
|
115
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Miscellaneous
|
46
|
Baseline Characteristics
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Baseline characteristics by cohort
| Measure |
Armodafinil 100 to 250 mg/Day
n=731 Participants
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
726 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
46.7 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
257 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
474 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
611 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional yearPopulation: Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
Outcome measures
| Measure |
Armodafinil 100 to 250 mg/Day
n=731 Participants
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
|
667 Participants
|
Adverse Events
Armodafinil 100 to 250 mg/Day
Serious events: 56 serious events
Other events: 667 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Armodafinil 100 to 250 mg/Day
n=731 participants at risk
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.55%
4/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
2/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Angina pectoris
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Bradycardia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Sinus bradycardia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.27%
2/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Abdominical adhesions
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Diverticulitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Diverticulitis Intestinal
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Rectocele
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
General disorders
Chest Pain
|
0.82%
6/731 • For the duration of the study (up to 2 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Hepatobiliary disorders
Choletithiasis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Cellulitis
|
0.27%
2/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Appendicitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Bacteraemia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Bursitis Infective
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Gastroenteritis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Pnuemonia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Investigations
Cardioactive Drug Level Increased
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Localised Osteoarthritis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.27%
2/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukaemia
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis Cancer
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Headache
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Spinal Cord Compression
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
4/731 • For the duration of the study (up to 2 years)
|
|
Renal and urinary disorders
Cystocele
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Renal and urinary disorders
Stress Incontinence
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Renal and urinary disorders
Urethal Disorder
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Vascular disorders
Hypertension
|
0.27%
2/731 • For the duration of the study (up to 2 years)
|
|
Vascular disorders
Atherosclerosis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
|
Vascular disorders
Thrombosis
|
0.14%
1/731 • For the duration of the study (up to 2 years)
|
Other adverse events
| Measure |
Armodafinil 100 to 250 mg/Day
n=731 participants at risk
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.3%
68/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
49/731 • For the duration of the study (up to 2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
39/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Nasopharyngitis
|
16.8%
123/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
76/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Sinusitis
|
8.8%
64/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Influenza
|
7.5%
55/731 • For the duration of the study (up to 2 years)
|
|
Infections and infestations
Bronchitis
|
5.1%
37/731 • For the duration of the study (up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
59/731 • For the duration of the study (up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
53/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Headache
|
24.5%
179/731 • For the duration of the study (up to 2 years)
|
|
Nervous system disorders
Dizziness
|
6.4%
47/731 • For the duration of the study (up to 2 years)
|
|
Psychiatric disorders
Insomnia
|
13.5%
99/731 • For the duration of the study (up to 2 years)
|
|
Psychiatric disorders
Anxiety
|
7.8%
57/731 • For the duration of the study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
42/731 • For the duration of the study (up to 2 years)
|
|
Vascular disorders
Hypertension
|
5.5%
40/731 • For the duration of the study (up to 2 years)
|
Additional Information
Sponsor's Medical Director, Clinical Research
Cephalon
Phone: 1-877-237-4879
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60