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Trial record 84 of 240 for:    (armodafinil)

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

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ClinicalTrials.gov Identifier: NCT00228566
Recruitment Status : Completed
First Posted : September 29, 2005
Results First Posted : June 25, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Excessive Daytime Sleepiness
Narcolepsy
Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Intervention Drug: Armodafinil
Enrollment 247
Recruitment Details 40 centers in the US. First participant enrolled: 5 October 2005. Last participant last visit: 27 July 2006
Pre-assignment Details 1 female participant withdrew for noncompliance after randomization but prior to receiving study drug. The number of participants then analyzed (241) by a PGI-C rating was defined to be those participants who took at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment (5 patients did not meet this requirement).
Arm/Group Title Armodafinil 150 to 250 mg/Day
Hide Arm/Group Description Armodafinil 150 to 250 mg once daily in the morning
Period Title: Overall Study
Started 247
Completed 176
Not Completed 71
Reason Not Completed
Adverse Event             31
Lack of Efficacy             14
Lost to Follow-up             16
Physician Decision             5
Withdrawal by Subject             4
Miscellaneous             1
Arm/Group Title Armodafinil 150 to 250 mg/Day
Hide Arm/Group Description Armodafinil 150 to 250 mg once daily in the morning
Overall Number of Baseline Participants 247
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants
<=18 years 0
Between 18 and 65 years 243
>=65 years 3
[1]
Measure Description: 1 female participant withdrew for noncompliance after randomization but prior to receiving study drug
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants
46.6  (12.53)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants
Female 137
Male 109
[1]
Measure Description: 1 female participant withdrew for noncompliance after randomization but prior to receiving study drug
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 247 participants
247
1.Primary Outcome
Title Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
Hide Description A subjective measure (PGI-C rating) of the patient’s global health, ie, a patient’s rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
Time Frame Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil 150 to 250 mg/Day
Hide Arm/Group Description:
Armodafinil 150 to 250 mg once daily in the morning
Overall Number of Participants Analyzed 241
Measure Type: Number
Unit of Measure: Participants
241
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 to 250 mg/Day
Comments This was an open label study, with all patients receiving treatment with armodafinil
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Descriptive Statistics
Comments [Not Specified]
Method of Estimation Estimation Parameter % Responders = 201/241
Estimated Value 83.4
Confidence Interval 95%
78.7 to 88.1
Estimation Comments The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 150 to 250 mg/Day
Hide Arm/Group Description Armodafinil 150 to 250 mg once daily in the morning
All-Cause Mortality
Armodafinil 150 to 250 mg/Day
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 150 to 250 mg/Day
Affected / at Risk (%)
Total   6/246 (2.44%) 
Infections and infestations   
Pneumonia   1/246 (0.41%) 
Fetal growth retardation   1/246 (0.41%) 
Iliac artery occlusion   1/246 (0.41%) 
Nasal abscess   1/246 (0.41%) 
Cellulitis   1/246 (0.41%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain   1/246 (0.41%) 
Intervertebral disc protrusion   1/246 (0.41%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/246 (0.41%) 
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 150 to 250 mg/Day
Affected / at Risk (%)
Total   134/246 (54.47%) 
Gastrointestinal disorders   
Nausea   30/246 (12.20%) 
Dry mouth   22/246 (8.94%) 
Diarrhoea   13/246 (5.28%) 
Infections and infestations   
Nasopharyngitis   35/246 (14.23%) 
Upper respiratory tract infection   21/246 (8.54%) 
Nervous system disorders   
Headache   50/246 (20.33%) 
Dizziness   14/246 (5.69%) 
Psychiatric disorders   
Anxiety   16/246 (6.50%) 
Insomnia   15/246 (6.10%) 
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, Inc.
Phone: 1-877-237-4879
ClinicalTrials.gov Identifier: NCT00228566     History of Changes
Other Study ID Numbers: C10953/3046/ES/US
First Submitted: September 27, 2005
First Posted: September 29, 2005
Results First Submitted: June 1, 2009
Results First Posted: June 25, 2010
Last Update Posted: July 19, 2013