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Trial record 86 of 239 for:    (armodafinil)

Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)

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: NCT00078325
Recruitment Status : Completed
First Posted : February 25, 2004
Results First Posted : July 29, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions Obstructive Sleep Apnea
Hypopnea
Interventions Drug: Armodafinil 250 mg/day
Drug: Armodafinil 150 mg/day
Drug: Placebo
Enrollment 395
Recruitment Details 37 centers in the US and Canada. First patient enrolled: 19 February 2004/ Last patient last visit: 6 November 2004
Pre-assignment Details 3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
Arm/Group Title Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description Armodafinil 250 mg once daily in the morning Armodafinil 150 mg once daily in the morning Matching placebo tablets once daily
Period Title: Overall Study
Started 131 133 131
Completed 110 114 120
Not Completed 21 19 11
Reason Not Completed
Adverse Event             15             10             5
Protocol Violation             2             2             0
Withdrawal by Subject             1             5             3
Lost to Follow-up             0             1             1
Physician Decision             2             0             1
Miscellaneous             1             1             1
Arm/Group Title Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo Total
Hide Arm/Group Description Armodafinil 250 mg once daily in the morning Armodafinil 150 mg once daily in the morning Matching placebo tablets once daily Total of all reporting groups
Overall Number of Baseline Participants 131 131 130 392
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 131 participants 130 participants 392 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
130
  99.2%
131
 100.0%
129
  99.2%
390
  99.5%
>=65 years
1
   0.8%
0
   0.0%
1
   0.8%
2
   0.5%
[1]
Measure Description: 3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 131 participants 130 participants 392 participants
49.1  (8.74) 49.3  (9.17) 50.1  (9.43) 49.5  (9.10)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 131 participants 130 participants 392 participants
Female
42
  32.1%
34
  26.0%
40
  30.8%
116
  29.6%
Male
89
  67.9%
97
  74.0%
90
  69.2%
276
  70.4%
[1]
Measure Description: 3 female patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 131 participants 130 participants 392 participants
United States 117 119 117 353
Canada 14 14 14 42
1.Primary Outcome
Title Maintenance of Wakefulness Test (MWT)
Hide Description The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
Time Frame change from baseline at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)

Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy.

Arm/Group Title Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg once daily in the morning
Matching placebo tablets once daily
Overall Number of Participants Analyzed 121 120 124
Mean (Standard Deviation)
Unit of Measure: Minutes
2.2  (8.07) 1.7  (6.49) -1.7  (8.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments Treatment and country as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANOVA
Comments Treatment and country as factors.
2.Primary Outcome
Title Clinical Global Impression of Change (CGI-C)
Hide Description The CGI-C represents a subjective measure of the patient’s global health (clinician’s rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
Time Frame change from baseline at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)
Arm/Group Title Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg once daily in the morning
Matching placebo tablets once daily
Overall Number of Participants Analyzed 121 120 124
Measure Type: Number
Unit of Measure: Participants
121 120 124
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 250 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for country.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for country.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description Armodafinil 250 mg once daily in the morning Armodafinil 150 mg once daily in the morning Matching placebo tablets once daily
All-Cause Mortality
Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/131 (0.76%)   3/131 (2.29%)   0/130 (0.00%) 
Gastrointestinal disorders       
Colitis ulcerative   1/131 (0.76%)  0/131 (0.00%)  0/130 (0.00%) 
Duodenal ulcer haemorrhage   0/131 (0.00%)  1/131 (0.76%)  0/130 (0.00%) 
Nervous system disorders       
Migraine   0/131 (0.00%)  1/131 (0.76%)  0/130 (0.00%) 
Psychiatric disorders       
Affective disorder   0/131 (0.00%)  1/131 (0.76%)  0/130 (0.00%) 
Personality disorder   0/131 (0.00%)  1/131 (0.76%)  0/130 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil 250 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/131 (39.69%)   32/131 (24.43%)   19/130 (14.62%) 
Gastrointestinal disorders       
Nausea   13/131 (9.92%)  3/131 (2.29%)  6/130 (4.62%) 
Dry Mouth   10/131 (7.63%)  1/131 (0.76%)  0/130 (0.00%) 
Nervous system disorders       
Headache   27/131 (20.61%)  19/131 (14.50%)  11/130 (8.46%) 
Dizziness   8/131 (6.11%)  5/131 (3.82%)  2/130 (1.54%) 
Psychiatric disorders       
Insomnia   9/131 (6.87%)  8/131 (6.11%)  2/130 (1.54%) 
Indicates events were collected by systematic assessment
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
Name/Title: Sponsor's Medical Director, Clinical Research
Organization: Cephalon
Phone: 1-877-237-4879
ClinicalTrials.gov Identifier: NCT00078325     History of Changes
Other Study ID Numbers: C10953/3021/AP/MN
First Submitted: February 23, 2004
First Posted: February 25, 2004
Results First Submitted: June 1, 2009
Results First Posted: July 29, 2010
Last Update Posted: July 19, 2013