Trial Outcomes & Findings for Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (NCT NCT00078312)

Last Updated: 2013-07-19

Results Overview

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

328 participants

Primary outcome timeframe

Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter

Results posted on

2013-07-19

Participant Flow

41 centers (US 34, Russia 7). First patient enrolled: 30 January 2004/ Last patient last visit: 19 July 2006

5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant). These 5 patients are in the participant flow, but not in the safety data set since they did not receive study drug.

Participant milestones

Participant milestones
Measure	Armodafinil 100 to 250 mg/Day Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Overall Study STARTED	328
Overall Study COMPLETED	151
Overall Study NOT COMPLETED	177

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil 100 to 250 mg/Day Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Overall Study Adverse Event	43
Overall Study Lack of Efficacy	15
Overall Study Lost to Follow-up	41
Overall Study Physician Decision	9
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	33
Overall Study Miscellaneous	33

Baseline Characteristics

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 100 to 250 mg/Day n=328 Participants Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	326 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	45.2 years STANDARD_DEVIATION 11.27 • n=5 Participants
Gender Female	111 participants n=5 Participants
Gender Male	212 participants n=5 Participants
Region of Enrollment United States	267 participants n=5 Participants
Region of Enrollment Russian Federation	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter

Population: Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)

Outcome measures

Outcome measures
Measure	Armodafinil 100 to 250 mg/Day n=323 Participants Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Safety and Tolerability as Measured by Number of Participants With Adverse Events	323 Participants

Adverse Events

Armodafinil 100 to 250 mg/Day

Serious events: 12 serious events

Other events: 177 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 100 to 250 mg/Day n=323 participants at risk Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Cardiac disorders Myocardial infarction	0.31% 1/323
Cardiac disorders Tachycardia paroxysmal	0.31% 1/323
Gastrointestinal disorders Abdominal haematoma	0.31% 1/323
General disorders Chest pain	0.62% 2/323
General disorders Non-cardiac chest pain	0.31% 1/323
Metabolism and nutrition disorders Hypokalaemia	0.31% 1/323
Musculoskeletal and connective tissue disorders Back pain	0.31% 1/323
Nervous system disorders Multiple sclerosis	0.31% 1/323
Psychiatric disorders Depression	0.31% 1/323
Renal and urinary disorders Nephrolithiasis	0.31% 1/323
Reproductive system and breast disorders Menometrorrhagia	0.31% 1/323
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease exacerbated	0.31% 1/323
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.31% 1/323
Vascular disorders Haematoma	0.31% 1/323

Other adverse events

Other adverse events
Measure	Armodafinil 100 to 250 mg/Day n=323 participants at risk Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
Gastrointestinal disorders Nausea	8.4% 27/323
Infections and infestations Upper respiratory tract infection	10.2% 33/323
Infections and infestations Nasopharyngitis	5.6% 18/323
Infections and infestations Sinusitis	5.6% 18/323
Nervous system disorders Headache	17.0% 55/323
Nervous system disorders Dizziness	8.4% 27/323
Psychiatric disorders Insomnia	14.2% 46/323
Psychiatric disorders Anxiety	6.5% 21/323
Vascular disorders Hypertension	5.6% 18/323

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