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Trial record 52 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00797797
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Sponsor:
Information provided by:
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: No Treatment Added
Drug: Milnacipran Added
Enrollment 364
Recruitment Details Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.
Pre-assignment Details Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.
Arm/Group Title No Treatment Added Milnacipran Added
Hide Arm/Group Description No treatment added for 11 weeks of randomized treatment period Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
Period Title: Overall Study
Started 178 [1] 184
Completed 123 141
Not Completed 55 43
[1]
Two patients took no background stable dose of pregabalin after randomization and are not included.
Arm/Group Title No Treatment Added Milnacipran Added Total
Hide Arm/Group Description No treatment added for 11 weeks of randomized treatment period Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period Total of all reporting groups
Overall Number of Baseline Participants 178 184 362
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 178 participants 184 participants 362 participants
Between 18 and 60 years 151 146 297
>=60 years 27 38 65
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 184 participants 362 participants
48.8  (10.4) 49.8  (10.3) 49.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 184 participants 362 participants
Female
159
  89.3%
170
  92.4%
329
  90.9%
Male
19
  10.7%
14
   7.6%
33
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 178 participants 184 participants 362 participants
178 184 362
1.Primary Outcome
Title Patient Global Impression of Change (PGIC) Responder Rate at End of Study
Hide Description The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as “very much improved” or “much improved” (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
Time Frame End of Randomized treatment period (11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.
Arm/Group Title No Treatment Added Milnacipran Added
Hide Arm/Group Description:
No treatment added for 11 weeks of randomized treatment period
Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
Overall Number of Participants Analyzed 173 179
Measure Type: Number
Unit of Measure: participants
Responder 36 83
Non-Responder 137 96
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Treatment Added, Milnacipran Added
Comments The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
Hide Description The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).
Time Frame Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Treatment Added Milnacipran Added
Hide Arm/Group Description:
No treatment added for 11 weeks of randomized treatment period
Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
Overall Number of Participants Analyzed 173 179
Least Squares Mean (Standard Error)
Unit of Measure: mm
-6.43  (1.93) -20.77  (1.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Treatment Added, Milnacipran Added
Comments This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -14.35
Confidence Interval (2-Sided) 95%
-18.99 to -9.71
Estimation Comments [Not Specified]
Time Frame Treatment emergent adverse events, defined as adverse events which occurred or worsened after starting randomized study drug, were collected from December 2008 to November 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Treatment Added Milnacipran Added
Hide Arm/Group Description No treatment added for 11 weeks of randomized treatment period Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
All-Cause Mortality
No Treatment Added Milnacipran Added
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Treatment Added Milnacipran Added
Affected / at Risk (%) Affected / at Risk (%)
Total   6/178 (3.37%)   5/184 (2.72%) 
Gastrointestinal disorders     
Duodenitis  1  1/178 (0.56%)  0/184 (0.00%) 
Gastric ulcer  1  1/178 (0.56%)  0/184 (0.00%) 
Irritable bowel syndrome  1  0/178 (0.00%)  1/184 (0.54%) 
General disorders     
Chest discomfort  1  1/178 (0.56%)  0/184 (0.00%) 
Injury, poisoning and procedural complications     
Chest injury  1  1/178 (0.56%)  0/184 (0.00%) 
Road traffic accident  1  1/178 (0.56%)  0/184 (0.00%) 
Musculoskeletal and connective tissue disorders     
Inverteral disc disorder  1  1/178 (0.56%)  0/184 (0.00%) 
Psychiatric disorders     
Suicidal ideation  1  1/178 (0.56%)  2/184 (1.09%) 
Renal and urinary disorders     
Calculus ureteric  1  1/178 (0.56%)  0/184 (0.00%) 
Surgical and medical procedures     
Hysterectomy  1  0/178 (0.00%)  1/184 (0.54%) 
Vascular disorders     
Hypertensive crisis  1  0/178 (0.00%)  1/184 (0.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Treatment Added Milnacipran Added
Affected / at Risk (%) Affected / at Risk (%)
Total   38/178 (21.35%)   90/184 (48.91%) 
Cardiac disorders     
Palpitations  1  0/178 (0.00%)  10/184 (5.43%) 
Gastrointestinal disorders     
Nausea  1  5/178 (2.81%)  23/184 (12.50%) 
Constipation  1  1/178 (0.56%)  18/184 (9.78%) 
Dry Mouth  1  0/178 (0.00%)  10/184 (5.43%) 
General disorders     
Fatigue  1  4/178 (2.25%)  19/184 (10.33%) 
Oedema peripheral  1  15/178 (8.43%)  6/184 (3.26%) 
Investigations     
Weight Increased  1  15/178 (8.43%)  12/184 (6.52%) 
Nervous system disorders     
Headache  1  4/178 (2.25%)  17/184 (9.24%) 
Dizziness  1  1/178 (0.56%)  14/184 (7.61%) 
Psychiatric disorders     
Anxiety  1  3/178 (1.69%)  12/184 (6.52%) 
Insomnia  1  2/178 (1.12%)  10/184 (5.43%) 
Vascular disorders     
Hot flush  1  0/178 (0.00%)  11/184 (5.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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: Robert Palmer, MD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Phone: 1-201-427-8218
EMail: robert.palmer@frx.com
Layout table for additonal information
Responsible Party: James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
ClinicalTrials.gov Identifier: NCT00797797     History of Changes
Other Study ID Numbers: MLN-MD-15
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: November 18, 2010
Results First Posted: February 16, 2011
Last Update Posted: February 16, 2011