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Trial record 31 of 89 for:    "Neuromuscular Disease" | "Norepinephrine"

Drug and Talk Therapy for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01038323
Recruitment Status : Completed
First Posted : December 23, 2009
Results First Posted : July 21, 2016
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Other: CBT and milnacipran
Behavioral: CBT with a placebo
Drug: Educational with milnacipran
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy
Hide Arm/Group Description Combination cognitive behavioral therapy (CBT) and milnacipran Milnacipran (drug) only Cognitive behavioral therapy (CBT) only
Period Title: Overall Study
Started 20 19 19
Completed 17 17 15
Not Completed 3 2 4
Reason Not Completed
Withdrawal by Subject             3             2             4
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy Total
Hide Arm/Group Description Combination cognitive behavioral therapy (CBT) and milnacipran Milnacipran (drug) only Cognitive behavioral therapy (CBT) only Total of all reporting groups
Overall Number of Baseline Participants 20 19 19 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
19
 100.0%
19
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 19 participants 58 participants
44.8  (8.8) 47.8  (10.6) 47.11  (11.9) 46.5  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Female
19
  95.0%
19
 100.0%
16
  84.2%
54
  93.1%
Male
1
   5.0%
0
   0.0%
3
  15.8%
4
   6.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 19 participants 58 participants
20 19 19 58
Weekly average pain intensity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 19 participants 58 participants
6.2  (1.2) 6.3  (1.3) 6.3  (1.3) 6.3  (1.2)
[1]
Measure Description: Average of daily pain scores within a one-week period (scale from 0 to 10, with 10 being the worse possible pain)
1.Primary Outcome
Title Change in Weekly Average Pain Intensity
Hide Description Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)
Time Frame Baseline and Week 21clinic visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy
Hide Arm/Group Description:
Combination cognitive behavioral therapy (CBT) and milnacipran
Milnacipran (drug) only
Cognitive behavioral therapy (CBT) only
Overall Number of Participants Analyzed 17 17 15
Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (.43) -0.97  (0.43) -1.67  (0.45)
2.Secondary Outcome
Title Change in Evoked Pain Scores
Hide Description 0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli
Time Frame Baseline and Week 21 clinic visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy
Hide Arm/Group Description:
Combination cognitive behavioral therapy (CBT) and milnacipran
Milnacipran (drug) only
Cognitive behavioral therapy (CBT) only
Overall Number of Participants Analyzed 17 17 15
Mean (Standard Error)
Unit of Measure: units on a scale
-0.76  (1.2) -0.41  (1.2) 0.78  (1.2)
3.Secondary Outcome
Title Identification of Group Assignment
Hide Description Subjects identifying group assignment correctly
Time Frame week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Information not captured (unfortunately)
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy
Hide Arm/Group Description:
Combination cognitive behavioral therapy (CBT) and milnacipran
Milnacipran (drug) only
Cognitive behavioral therapy (CBT) only
Overall Number of Participants Analyzed 17 17 15
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame 21 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Milnacipran Cognitive Behavioral Therapy
Hide Arm/Group Description Cognitive behavioral therapy + milnacipran milnacipran + education Cognitive behavioral therapy + placebo
All-Cause Mortality
Combination Milnacipran Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination Milnacipran Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Milnacipran Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/20 (45.00%)      8/19 (42.11%)      3/19 (15.79%)    
Gastrointestinal disorders       
nausea  [1]  9/20 (45.00%)  9 8/19 (42.11%)  8 3/19 (15.79%)  3
Indicates events were collected by systematic assessment
[1]
transient nausea
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: dennis ang
Organization: Wake Forest
Phone: 336-716-4209
EMail: dang@wakehealth.edu
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01038323     History of Changes
Other Study ID Numbers: IU 0904-08
1R21AR056046-01A2 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2009
First Posted: December 23, 2009
Results First Submitted: April 14, 2016
Results First Posted: July 21, 2016
Last Update Posted: March 6, 2017