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Trial record 87 of 135 for:    AMITRIPTYLINE

An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue

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: NCT00678691
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia, Primary
Interventions Drug: armodafinil
Drug: placebo
Enrollment 55
Recruitment Details Subjects were easily recruited and screened for study entry
Pre-assignment Details Subjects were exluded after informed consent if medical confounding variables or safety variables were found
Arm/Group Title A,1 Armodafinil Study Drug 50-250mg Flexible Dose A,2 Matching Placebo
Hide Arm/Group Description armodafinil placebo
Period Title: Overall Study
Started 27 28
Completed 21 24
Not Completed 6 4
Reason Not Completed
Adverse Event             6             4
Arm/Group Title A,1 Armodafinil Study Drug A,2 Matching Placebo Total
Hide Arm/Group Description armodafinil placebo Total of all reporting groups
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
28
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
50  (4) 47  (4) 49  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
25
  92.6%
25
  89.3%
50
  90.9%
Male
2
   7.4%
3
  10.7%
5
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 28 participants 55 participants
27 28 55
1.Primary Outcome
Title Brief Fatigue Inventory
Hide Description This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
last observation carried forward after power analysis calculated
Arm/Group Title A,1 Armodafinil Study Drug A,2 Matching Placebo
Hide Arm/Group Description:
armodafinil
placebo
Overall Number of Participants Analyzed 27 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.86  (.149) 4.29  (.144)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A,1 Armodafinil Study Drug, A,2 Matching Placebo
Comments Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 – week 8).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments all p-values come from one model analysis and are therefore included in free text as such
Method piecewise model
Comments A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 – week 8
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A,1 Armodafinil Study Drug A,2 Matching Placebo
Hide Arm/Group Description armodafinil placebo
All-Cause Mortality
A,1 Armodafinil Study Drug A,2 Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A,1 Armodafinil Study Drug A,2 Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
A,1 Armodafinil Study Drug A,2 Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/27 (33.33%)   8/28 (28.57%) 
Gastrointestinal disorders     
dry mouth   3/27 (11.11%)  3/28 (10.71%) 
Psychiatric disorders     
Poor Concentration   2/27 (7.41%)  2/27 (7.41%) 
Vascular disorders     
headache   4/27 (14.81%)  3/28 (10.71%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Thomas Schwartz
Organization: SUNY Upstate Medical University
Phone: 3154643166
EMail: schwartt@upstate.edu
Layout table for additonal information
Responsible Party: Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00678691     History of Changes
Obsolete Identifiers: NCT00568919
Other Study ID Numbers: ArmoFibro-001
First Submitted: May 13, 2008
First Posted: May 15, 2008
Results First Submitted: September 6, 2012
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014