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Trial record 35 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00793520
Recruitment Status : Terminated
First Posted : November 19, 2008
Results First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Milnacipran
Drug: Placebo
Enrollment 2
Recruitment Details The recruitment period was from November 2008 to April 2009 at one university location.
Pre-assignment Details Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.
Arm/Group Title Milnacipran to Placebo Placebo to Placebo
Hide Arm/Group Description Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Period Title: Milnacipran Crossover to Placebo
Started 1 0
Completed 0 0
Not Completed 1 0
Period Title: Placebo Crossover to Milnacipran
Started 0 1
Completed 0 0
Not Completed 0 1
Arm/Group Title Milnacipran to Placebo Placebo to Placebo Total
Hide Arm/Group Description Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
37 48 42.5  (7.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
Hide Description Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.
Time Frame Week 0, 5, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Milnacipran to Placebo Placebo to Placebo
Hide Arm/Group Description:
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Hide Description DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient’s right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC
Time Frame Weeks 0, 5, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Milnacipran to Placebo Placebo to Placebo
Hide Arm/Group Description:
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
All-Cause Mortality
Milnacipran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Milnacipran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Milnacipran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/1 (100.00%) 
Gastrointestinal disorders     
Food poisoning  1  1/1 (100.00%)  0/1 (0.00%) 
Abdominal pain upper  1  1/1 (100.00%)  0/1 (0.00%) 
Infections and infestations     
Gastroenteritis viral  1  1/1 (100.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders     
Fibromyalgia  1  0/1 (0.00%)  1/1 (100.00%) 
Nervous system disorders     
Headache  1  1/1 (100.00%)  1/1 (100.00%) 
Dizziness  1  1/1 (100.00%)  0/1 (0.00%) 
Psychiatric disorders     
Nightmares  1  1/1 (100.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Early termination leading to small numbers of subjects enrolled. Technical problems with MRI equipment resulted in early study termination. No analysis was performed.
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: Allan Spera
Organization: Forest Research Institute
Phone: 201-427-8399
EMail: allan.spera@frx.com
Layout table for additonal information
Responsible Party: James Perhach, PhD, Executive Director, Clinical Development, Neurology, Forest Research Insititute
ClinicalTrials.gov Identifier: NCT00793520     History of Changes
Other Study ID Numbers: MLN-MD-16
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: April 15, 2010
Results First Posted: July 1, 2010
Last Update Posted: July 1, 2010