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Trial record 96 of 240 for:    (armodafinil)

Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

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ClinicalTrials.gov Identifier: NCT00236080
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : February 3, 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
Condition Chronic Shift Work Sleep Disorder
Interventions Drug: PROVIGIL 200 mg
Drug: Armodafinil 250 mg
Drug: Armodafinil 200 mg
Drug: Armodafinil 150 mg
Drug: Placebo
Enrollment 136
Recruitment Details 16 centers in the US. First participant enrolled: 7 September 2005/ Last participant last visit: 1 December 2005
Pre-assignment Details 2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)
Arm/Group Title PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description PROVIGIL 200 mg once daily only on nights worked Armodafinil 250 mg once daily only on nights worked Armodafinil 200 mg once daily only on nights worked Armodafinil 150 mg once daily only on nights worked Matching placebo tablets once daily only on nights worked
Period Title: Overall Study
Started 29 28 27 25 27
Completed 27 27 22 23 26
Not Completed 2 1 5 2 1
Reason Not Completed
Adverse Event             0             0             3             1             0
Lost to Follow-up             0             1             0             0             0
Physician Decision             1             0             1             1             1
Withdrawal by Subject             1             0             0             0             0
Miscellaneous             0             0             1             0             0
Arm/Group Title PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo Total
Hide Arm/Group Description PROVIGIL 200 mg once daily only on nights worked Armodafinil 250 mg once daily only on nights worked Armodafinil 200 mg once daily only on nights worked Armodafinil 150 mg once daily only on nights worked Matching placebo tablets once daily only on nights worked Total of all reporting groups
Overall Number of Baseline Participants 29 28 27 25 27 136
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 27 participants 25 participants 27 participants 136 participants
<=18 years 0 0 0 0 0 0
Between 18 and 65 years 29 28 26 25 26 134
>=65 years 0 0 0 0 0 0
[1]
Measure Description: 2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 27 participants 25 participants 27 participants 136 participants
36.8  (8.92) 34.3  (9.87) 34.5  (7.60) 38.3  (12.83) 38.0  (9.83) 36.3  (9.90)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 27 participants 25 participants 27 participants 136 participants
Female 18 12 13 8 6 57
Male 11 16 13 17 20 77
[1]
Measure Description: 2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 28 participants 27 participants 25 participants 27 participants 136 participants
29 28 26 25 26 134
[1]
Measure Description: 2 male participants withdrew after randomization but prior to receiving study drug (1 for noncompliance and 1 at the request of the sponsor)
1.Primary Outcome
Title Multiple Sleep Latency Test (MSLT)
Hide Description The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.
Time Frame Endpoint (Visit 4) change from baseline (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
  • 1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a "Completer".
  • 1 Patient in the "Armodafinil 200 mg/day group" had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a "Non-Completer" for the Study.
Arm/Group Title PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg once daily only on nights worked
Matching placebo tablets once daily only on nights worked
Overall Number of Participants Analyzed 27 27 23 23 25
Mean (Standard Deviation)
Unit of Measure: Minutes
2.0  (3.05) 3.7  (4.33) 3.7  (5.07) 2.7  (4.24) 1.1  (3.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROVIGIL 200 mg/Day, Armodafinil 250 mg/Day, Armodafinil 200 mg/Day, Armodafinil 150 mg/Day, Placebo
Comments Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.
Statistical Test of Hypothesis P-Value 0.1236
Comments The p-value of Overall Treatment to Placebo
Method ANCOVA
Comments This analysis adjusted for the difference among the treatment groups at baseline.
2.Primary Outcome
Title Psychomotor Vigilance Task (PVT)
Hide Description The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.
Time Frame Endpoint (Visit 4) change from baseline (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.
Arm/Group Title PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
PROVIGIL 200 mg once daily only on nights worked
Armodafinil 250 mg once daily only on nights worked
Armodafinil 200 mg once daily only on nights worked
Armodafinil 150 mg once daily only on nights worked
Matching placebo tablets once daily only on nights worked
Overall Number of Participants Analyzed 26 27 22 22 26
Mean (Standard Deviation)
Unit of Measure: Milliseconds
-16.5  (27.58) -29.8  (38.35) -37.4  (63.16) -33.1  (44.52) 2.4  (34.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROVIGIL 200 mg/Day, Armodafinil 250 mg/Day, Armodafinil 200 mg/Day, Armodafinil 150 mg/Day, Placebo
Comments Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using the adjusted p value from Tukey’s least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.
Statistical Test of Hypothesis P-Value 0.0945
Comments The p-value of Overall Treatment to Placebo
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description PROVIGIL 200 mg once daily only on nights worked Armodafinil 250 mg once daily only on nights worked Armodafinil 200 mg once daily only on nights worked Armodafinil 150 mg once daily only on nights worked Matching placebo tablets once daily only on nights worked
All-Cause Mortality
PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%)   0/26 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PROVIGIL 200 mg/Day Armodafinil 250 mg/Day Armodafinil 200 mg/Day Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/29 (17.24%)   8/28 (28.57%)   9/26 (34.62%)   4/25 (16.00%)   3/26 (11.54%) 
Gastrointestinal disorders           
Nausea   0/29 (0.00%)  2/28 (7.14%)  1/26 (3.85%)  0/25 (0.00%)  1/26 (3.85%) 
Dry mouth   1/29 (3.45%)  2/28 (7.14%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite   1/29 (3.45%)  3/28 (10.71%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain   0/29 (0.00%)  0/28 (0.00%)  2/26 (7.69%)  1/25 (4.00%)  0/26 (0.00%) 
Nervous system disorders           
Headache   4/29 (13.79%)  3/28 (10.71%)  3/26 (11.54%)  3/25 (12.00%)  2/26 (7.69%) 
Dizziness   1/29 (3.45%)  0/28 (0.00%)  3/26 (11.54%)  0/25 (0.00%)  1/26 (3.85%) 
Psychiatric disorders           
Insomnia   2/29 (6.90%)  0/28 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
In analyzing the PVT data, it was discovered that data transfer errors had occurred at certain study centers. The ability to interpret the efficacy results from this study is limited, and the findings should be considered inconclusive.
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, Inc.
Phone: 1-877-237-4879
Layout table for additonal information
Responsible Party: Sponsor's Medical Expert, Cephalon
ClinicalTrials.gov Identifier: NCT00236080     History of Changes
Other Study ID Numbers: C10953/3045/CM/US
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: June 1, 2009
Results First Posted: February 3, 2010
Last Update Posted: July 19, 2013