Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

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: NCT01077375
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Placebo
Drug: Milnacipran
Enrollment 107
Recruitment Details Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.
Pre-assignment Details

All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.

Patients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind.

Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration. Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
Period Title: Overall Study
Started 21 86 [1]
Completed 11 51
Not Completed 10 35
Reason Not Completed
Adverse Event             2             15
Lack of Efficacy             6             8
Withdrawal by Subject             0             6
Lost to Follow-up             2             5
Other Reason             0             1
[1]
One randomized patient not taking study drug was excluded from the Double-blind Safety Population.
Arm/Group Title Placebo Milnacipran Total
Hide Arm/Group Description Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.

Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.

One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.

Total of all reporting groups
Overall Number of Baseline Participants 21 85 106
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 85 participants 106 participants
48.5  (11.3) 48.5  (10.5) 48.5  (10.6)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 85 participants 106 participants
18 to 59 17 77 94
60 to 70 4 8 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 85 participants 106 participants
Female
19
  90.5%
79
  92.9%
98
  92.5%
Male
2
   9.5%
6
   7.1%
8
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 85 participants 106 participants
21 85 106
1.Primary Outcome
Title Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
Hide Description The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.
Time Frame Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.

Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.

Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5).

Overall Number of Participants Analyzed 21 79
Measure Type: Number
Unit of Measure: participants
5 26
2.Secondary Outcome
Title Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
Hide Description The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Time Frame Change from Baseline (Week 3) to Visit 5 (Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.

Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.

Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)

Overall Number of Participants Analyzed 21 79
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.3  (22.5) -12.3  (27.3)
Time Frame Adverse event data was collected over a nearly 10 month period from March 4th, 2010 through December 22, 2010.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.

Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.

One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.

Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5).

All-Cause Mortality
Placebo Milnacipran
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Milnacipran
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   2/85 (2.35%) 
Immune system disorders     
Hypersensitivity  1  0/21 (0.00%)  1/85 (1.18%) 
Psychiatric disorders     
Suicidal ideation  1  0/21 (0.00%)  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Milnacipran
Affected / at Risk (%) Affected / at Risk (%)
Total   16/21 (76.19%)   63/85 (74.12%) 
Gastrointestinal disorders     
Nausea  1  6/21 (28.57%)  18/85 (21.18%) 
Diarrhea  1  3/21 (14.29%)  4/85 (4.71%) 
General disorders     
Irritability  1  1/21 (4.76%)  6/85 (7.06%) 
Fatigue  1  2/21 (9.52%)  3/85 (3.53%) 
Infections and infestations     
Nasopharyngitis  1  0/21 (0.00%)  6/85 (7.06%) 
Investigations     
Blood pressure increased  1  0/21 (0.00%)  5/85 (5.88%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  2/21 (9.52%)  0/85 (0.00%) 
Nervous system disorders     
Dizziness  1  1/21 (4.76%)  13/85 (15.29%) 
Headache  1  2/21 (9.52%)  10/85 (11.76%) 
Migraine  1  2/21 (9.52%)  1/85 (1.18%) 
Paresthesia  1  2/21 (9.52%)  1/85 (1.18%) 
Psychiatric disorders     
Insomnia  1  2/21 (9.52%)  9/85 (10.59%) 
Anxiety  1  0/21 (0.00%)  5/85 (5.88%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/21 (0.00%)  5/85 (5.88%) 
Vascular disorders     
Hot flush  1  1/21 (4.76%)  7/85 (8.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allan Spera, Director, Clinical Development
Organization: Forest Research Institute
Phone: (201) 427-8399
EMail: Allan.Spera@frx.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01077375     History of Changes
Other Study ID Numbers: MLN-MD-28
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: December 21, 2011
Results First Posted: January 26, 2012
Last Update Posted: January 26, 2012