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Trial record 59 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial

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ClinicalTrials.gov Identifier: NCT01829243
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fibromyalgia
Neurocognition
Interventions Drug: Milnacipran
Drug: Placebo
Enrollment 26
Recruitment Details Patients were randomized to receiving milnacipran-washout-placebo or placebo- washout-milnacipran for 6 weeks, followed by a 1 week washout and then cross over to the other arm for another 6 weeks. The overall trial lasted 13 weeks starting on July 2011 and ending in May 2013.
Pre-assignment Details  
Arm/Group Title Milnacipran First, Then Placebo Placebo First, Then Milnacipran
Hide Arm/Group Description Patients randomized to receiving milnacipran first. Patients randomized to receive placebo first
Period Title: First Intervention
Started 11 15
Completed 7 13
Not Completed 4 2
Reason Not Completed
Screen Failure             4             2
Period Title: Washout Period of 1 Week
Started 7 13
Completed 7 13
Not Completed 0 0
Period Title: Second Intervention
Started 7 13
Completed 7 13
Not Completed 0 0
Arm/Group Title Subjects Who Completed the Study
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Baseline information is presented for subjects who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
47.6  (9.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
18
  90.0%
Male
2
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Visual Analogue Scale for Pain
Hide Description Visual Analogue Scale for Pain operationally is a 100 mm line anchored by word descriptors at each end. The patient marks a point on the line that reflects their current pain state. The distance in mm from the left anchor point is the score. Higher scores indicate more pain.
Time Frame Baseline, Week 1, 2,4, and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description:
Data is summarize for all patients while they were taking Milnacipran.
Data is summarize for all patients while they were taking the placebo.
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: mm
Week 0
59.4
(4.5 to 59.5)
68.6
(3.9 to 69.4)
Week 1
58.5
(3.4 to 59.1)
66.2
(3.4 to 67.3)
Week 2
55.7
(3.0 to 56.3)
61.5
(3.1 to 62.6)
Week 4
56.9
(2.7 to 57.1)
54.4
(2.8 to 55.2)
week 6
54.4
(2.7 to 55.9)
60.4
(2.5 to 60.5)
2.Primary Outcome
Title Changes in The Fatigue Severity Scale (FSS)
Hide Description

The Fatigue Severity Scale (FSS) is composed of nine items with a seven-point response format. The minimum score = 9 and maximum score possible = 63. Higher scores = greater fatigue severity.

Sample questions include "I am easily fatigued" and "Exercise brings on my fatigue." In the initial validation study, internal consistency for the Fatigue Severity Scale was high for specific illness groups (MS and lupus) and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. The Fatigue Severity Scale is also a practical measure due to its brevity and ease of administration and scoring.

Time Frame Baseline, Week 1, 2,4, and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description:
Data is summarize for all patients while they were taking Milnacipran.
Data is summarize for all patients while they were taking the placebo.
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: units on a scale
Week 0
56.3
(44.0 to 56.7)
49.2
(44.0 to 49.2)
Week 1
54.0
(44.0 to 54.5)
53.4
(44.0 to 53.6)
Week 2
53.7
(44.0 to 53.7)
52.2
(44.0 to 52.5)
Week 4
54.1
(44.0 to 54.5)
52.8
(44.0 to 53.1)
Week 6
52.1
(44.0 to 52.5)
53.0
(44.0 to 53.7)
3.Primary Outcome
Title Composite Brief Assessment of Cognition (BAC) Score
Hide Description The composite BAC score is calculated by scoring each of the 6 individual tests (Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London), comparing each score to a healthy control sample to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description:
Data is summarize for all patients while they were taking Milnacipran
Data is summarize for all patients while they were taking the placebo.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 41.2  (7.3) 40.9  (10.4)
Week 6 42.9  (8.0) 42.9  (7.8)
4.Secondary Outcome
Title MATRICS Consensus Cognitive Battery Composite Score
Hide Description

(MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.

The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning.

Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description:
Data is summarize for all patients while they were taking the Milnacipran.
Data is summarize for all patients while they were taking the placebo.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 41.4  (7.4) 37.8  (9.6)
Week 1 41.0  (9.7) 40.6  (10.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Milnacipran Placebo
Hide Arm/Group Description Adverse events in this group occurred while subjects were taking Milnacipran. Adverse events in this group occurred while subjects were taking Placebo.
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   0/20 (0.00%)   0/20 (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   12/20 (60.00%)   18/20 (90.00%) 
Gastrointestinal disorders     
Dry Mouth  0/20 (0.00%)  2/20 (10.00%) 
Nausea  3/20 (15.00%)  1/20 (5.00%) 
Diarrhea  0/20 (0.00%)  1/20 (5.00%) 
General disorders     
Insomnia  2/20 (10.00%)  6/20 (30.00%) 
Tiredness  0/20 (0.00%)  1/20 (5.00%) 
Pain  1/20 (5.00%)  4/20 (20.00%) 
Metabolism and nutrition disorders     
Appetite change  1/20 (5.00%)  1/20 (5.00%) 
Nervous system disorders     
Dizziness  1/20 (5.00%)  2/20 (10.00%) 
Restlessness  0/20 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
Depression  2/20 (10.00%)  2/20 (10.00%) 
Renal and urinary disorders     
Urinary difficulty  1/20 (5.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Itching  1/20 (5.00%)  0/20 (0.00%) 
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: Ashwin A. Patkar, MD
Organization: Duke University Medical Center
Phone: 919-668-3626
EMail: ashwin.patkar@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01829243     History of Changes
Other Study ID Numbers: Pro00026392
First Submitted: April 9, 2013
First Posted: April 11, 2013
Results First Submitted: July 16, 2014
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014