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Trial record 28 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

The Effect of Milnacipran in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01108731
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 15, 2014
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

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: Milnacipran
Drug: Placebo
Enrollment 37
Recruitment Details  
Pre-assignment Details We got informed consent from 37 patients but excluded 3 -- 2 for saving psychiatric diagnoses that were exclusionary and one for having a metal implant which was an exclusion for neuroimaging. Thus 34 patients were randomized for the trial.
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo
Hide Arm/Group Description Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study. Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Period Title: Overall Study
Started 17 17
Completed 13 13
Not Completed 4 4
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             3             3
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo Total
Hide Arm/Group Description Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study. Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
Had to report widespread pain and to have at least 11 of 18 tender points [rated on a 0 to 10 pain intensity scale at 2 or higher].
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
48  (4) 47  (5) 47  (4)
[1]
Measure Description: Age on intake, continuous
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
13
 100.0%
13
 100.0%
26
 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 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Change in Ventricular Lactate Levels in the Brain
Hide Description Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.
Time Frame Baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
One drug treated and two placebo treated could not be analyzed due to excessive head motion
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo
Hide Arm/Group Description:
Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: international units (iu)
-0.87  (0.91) 0.32  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Taking the Drug Minalcipran, Patients Taking the Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method General Linear Model (GLM)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).
Hide Description The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.
Time Frame Baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo
Hide Arm/Group Description:
Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: latency to respond (msecs.)
No cue condition -79.56  (80.45) -35.00  (90.09)
Executive attention -68.73  (52.77) -34.77  (52.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Taking the Drug Minalcipran, Patients Taking the Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method General Linear Model (GLM)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Widespread Pain
Hide Description Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all 26 participants were used for analysis.
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo
Hide Arm/Group Description:
Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.24  (1.57) 0.66  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Taking the Drug Minalcipran, Patients Taking the Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame During the 2 month trial
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Taking the Drug Minalcipran Patients Taking the Placebo
Hide Arm/Group Description Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study. Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
All-Cause Mortality
Patients Taking the Drug Minalcipran Patients Taking the Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Taking the Drug Minalcipran Patients Taking the Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Taking the Drug Minalcipran Patients Taking the Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/17 (11.76%)   1/17 (5.88%) 
Gastrointestinal disorders     
Gastric distress, nausea or vomiting * [1]  2/17 (11.76%)  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
[1]
A continuum of gastric distress, to nausea or frank vomiting
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Benjamin Natelson
Organization: Beth_IsraelMC
Phone: 212-844-6747
EMail: bnatelson@chpnet.org
Layout table for additonal information
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108731     History of Changes
Other Study ID Numbers: BIMC #212-09
First Submitted: March 30, 2010
First Posted: April 22, 2010
Results First Submitted: July 7, 2014
Results First Posted: October 15, 2014
Last Update Posted: June 30, 2016