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Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

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: NCT00228553
Recruitment Status : Completed
First Posted : September 29, 2005
Results First Posted : March 31, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Excessive Daytime Sleepiness
Narcolepsy
Obstructive Sleep Apnea/Hypopnea Syndrome
Chronic Shift Work Sleep Disorder
Intervention Drug: Armodafinil 100 to 250 mg/day
Enrollment 743
Recruitment Details 99 centers in the US, Canada, France, Germany, Russia, and Australia. First participant enrolled: 15 May 2004/ Last participant last visit: 19 July 2006
Pre-assignment Details 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
Arm/Group Title Armodafinil 100 to 250 mg/Day
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 743
Completed 313
Not Completed 430
Reason Not Completed
Adverse Event             112
Lack of Efficacy             34
Lost to Follow-up             67
Physician Decision             48
Protocol Violation             6
Withdrawal by Subject             115
Pregnancy             2
Miscellaneous             46
Arm/Group Title Armodafinil 100 to 250 mg/Day
Hide Arm/Group Description 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 Number of Baseline Participants 731
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 731 participants
<=18 years
0
   0.0%
Between 18 and 65 years
726
  99.3%
>=65 years
5
   0.7%
[1]
Measure Description: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 731 participants
46.7  (10.97)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 731 participants
Female
257
  35.2%
Male
474
  64.8%
[1]
Measure Description: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 731 participants
France 8
United States 611
Canada 70
Australia 25
Russian Federation 16
Germany 13
1.Primary Outcome
Title Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)
Hide Description 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.
Time Frame End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.
Arm/Group Title Armodafinil 100 to 250 mg/Day
Hide Arm/Group Description:
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 Number of Participants Analyzed 731
Measure Type: Number
Unit of Measure: Participants
667
Time Frame For the duration of the study (up to 2 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 100 to 250 mg/Day
Hide Arm/Group Description 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)
All-Cause Mortality
Armodafinil 100 to 250 mg/Day
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 100 to 250 mg/Day
Affected / at Risk (%)
Total   56/731 (7.66%) 
Cardiac disorders   
Myocardial infarction  1  4/731 (0.55%) 
Coronary artery disease  1  2/731 (0.27%) 
Angina pectoris  1  1/731 (0.14%) 
Atrial fibrillation  1  1/731 (0.14%) 
Bradycardia  1  1/731 (0.14%) 
Cardiac failure congestive  1  1/731 (0.14%) 
Sinus bradycardia  1  1/731 (0.14%) 
Supraventricular tachycardia  1  1/731 (0.14%) 
Ventricular fibrillation  1  1/731 (0.14%) 
Ventricular tachycardia  1  1/731 (0.14%) 
Gastrointestinal disorders   
Haemorrhoidal haemorrhage  1  2/731 (0.27%) 
Abdominical adhesions  1  1/731 (0.14%) 
Abdominal Hernia  1  1/731 (0.14%) 
Diverticulitis  1  1/731 (0.14%) 
Diverticulitis Intestinal  1  1/731 (0.14%) 
Gastric Ulcer Haemorrhage  1  1/731 (0.14%) 
Gastrooesophageal Reflux Disease  1  1/731 (0.14%) 
Hiatus Hernia  1  1/731 (0.14%) 
Intestinal Obstruction  1  1/731 (0.14%) 
Pancreatitis  1  1/731 (0.14%) 
Rectocele  1  1/731 (0.14%) 
General disorders   
Chest Pain  1  6/731 (0.82%) 
Hepatobiliary disorders   
Cholecystitis  1  1/731 (0.14%) 
Cholecystitis Chronic  1  1/731 (0.14%) 
Choletithiasis  1  1/731 (0.14%) 
Infections and infestations   
Cellulitis  1  2/731 (0.27%) 
Appendicitis  1  1/731 (0.14%) 
Bacteraemia  1  1/731 (0.14%) 
Bursitis Infective  1  1/731 (0.14%) 
Gastroenteritis  1  1/731 (0.14%) 
Pnuemonia  1  1/731 (0.14%) 
Pyelonephritis  1  1/731 (0.14%) 
Injury, poisoning and procedural complications   
Arthropod Bite  1  1/731 (0.14%) 
Epicondylitis  1  1/731 (0.14%) 
Heat Stroke  1  1/731 (0.14%) 
Pelvic Fracture  1  1/731 (0.14%) 
Rib Fracture  1  1/731 (0.14%) 
Skin Laceration  1  1/731 (0.14%) 
Tendon Rupture  1  1/731 (0.14%) 
Investigations   
Cardioactive Drug Level Increased  1  1/731 (0.14%) 
Metabolism and nutrition disorders   
Diabetes Mellitus  1  1/731 (0.14%) 
Musculoskeletal and connective tissue disorders   
Localised Osteoarthritis  1  1/731 (0.14%) 
Tenosynovitis  1  1/731 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate Cancer  1  2/731 (0.27%) 
Chronic Myeloid Leukaemia  1  1/731 (0.14%) 
Colon Cancer  1  1/731 (0.14%) 
Gastric Cancer  1  1/731 (0.14%) 
Non-Hodgkin's Lymphoma  1  1/731 (0.14%) 
Parathyroid Tumour Benign  1  1/731 (0.14%) 
Testis Cancer  1  1/731 (0.14%) 
Nervous system disorders   
Headache  1  1/731 (0.14%) 
Intracranial Aneurysm  1  1/731 (0.14%) 
Spinal Cord Compression  1  1/731 (0.14%) 
Transient Ischaemic Attack  1  1/731 (0.14%) 
Renal and urinary disorders   
Nephrolithiasis  1  4/731 (0.55%) 
Cystocele  1  1/731 (0.14%) 
Renal Failure Acute  1  1/731 (0.14%) 
Stress Incontinence  1  1/731 (0.14%) 
Urethal Disorder  1  1/731 (0.14%) 
Reproductive system and breast disorders   
Adenomyosis  1  1/731 (0.14%) 
Dysfunctional Uterine Bleeding  1  1/731 (0.14%) 
Uterine Polyp  1  1/731 (0.14%) 
Uterine Prolapse  1  1/731 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/731 (0.14%) 
Atelectasis  1  1/731 (0.14%) 
Pneumothorax  1  1/731 (0.14%) 
Pulmonary Embolism  1  1/731 (0.14%) 
Pulmonary Oedema  1  1/731 (0.14%) 
Vascular disorders   
Hypertension  1  2/731 (0.27%) 
Atherosclerosis  1  1/731 (0.14%) 
Thrombosis  1  1/731 (0.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil 100 to 250 mg/Day
Affected / at Risk (%)
Total   667/731 (91.24%) 
Gastrointestinal disorders   
Nausea  1  68/731 (9.30%) 
Dry mouth  1  49/731 (6.70%) 
Diarrhoea  1  39/731 (5.34%) 
Infections and infestations   
Nasopharyngitis  1  123/731 (16.83%) 
Upper respiratory tract infection  1  76/731 (10.40%) 
Sinusitis  1  64/731 (8.76%) 
Influenza  1  55/731 (7.52%) 
Bronchitis  1  37/731 (5.06%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  59/731 (8.07%) 
Back pain  1  53/731 (7.25%) 
Nervous system disorders   
Headache  1  179/731 (24.49%) 
Dizziness  1  47/731 (6.43%) 
Psychiatric disorders   
Insomnia  1  99/731 (13.54%) 
Anxiety  1  57/731 (7.80%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  42/731 (5.75%) 
Vascular disorders   
Hypertension  1  40/731 (5.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sponsor's Medical Director, Clinical Research
Organization: Cephalon
Phone: 1-877-237-4879
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00228553     History of Changes
Other Study ID Numbers: C10953/3024/ES/MN
First Submitted: September 27, 2005
First Posted: September 29, 2005
Results First Submitted: June 1, 2009
Results First Posted: March 31, 2010
Last Update Posted: July 19, 2013