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Trial record 37 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring

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ClinicalTrials.gov Identifier: NCT00618956
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : September 3, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by:
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: Milnacipran hydrochloride
Drug: Placebo
Enrollment 321
Recruitment Details Recruitment period was from October 15, 2007 to April 16, 2008 at 38 centers in the US.
Pre-assignment Details Following 1-to-4 week washout/single-blind placebo lead-in period, patients were randomized (2:1) to one of the treatment groups, milnacipran or placebo, respectively; and orally treated with study medication for 7-week, double-blind treatment period (Visit 2 to 6), followed by a 2-week single-blind placebo discontinuation period (Visit 6 to 8).
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description ITT N= 93, OC analyzed n=89 Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
Period Title: Overall Study
Started 111 210
Completed 86 160
Not Completed 25 50
Reason Not Completed
Adverse Event             10             34
Lack of Efficacy             2             1
Withdrawal by Subject             5             7
Lost to Follow-up             4             5
Protocol Violation             2             2
did not meet criteria, non-compliance             2             1
Arm/Group Title Placebo Milnacipran Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 111 210 321
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 210 participants 321 participants
48.9  (11.1) 48.3  (10.9) 48.5  (11.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 210 participants 321 participants
< 20 years 1 2 3
20-59 years 91 174 265
>= 60 years 19 34 53
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 210 participants 321 participants
Female
109
  98.2%
198
  94.3%
307
  95.6%
Male
2
   1.8%
12
   5.7%
14
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 210 participants 321 participants
111 210 321
1.Primary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4
Hide Description Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.
Time Frame 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
Overall Number of Participants Analyzed 89 176
Mean (Standard Error)
Unit of Measure: mm Hg
Change in SBP in Normotensive Patients -0.9  (1.0) 4.0  (0.8)
Change in SBP in Hypertensive Patients 0.2  (1.1) 3.7  (1.0)
2.Primary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6
Hide Description Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.
Time Frame 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
Overall Number of Participants Analyzed 84 162
Mean (Standard Error)
Unit of Measure: mm Hg
Change in SBP in Normotensive Patients 0.1  (1.3) 5.5  (0.9)
Change in SBP in Hypertensive Patients -0.9  (1.4) 4.4  (1.0)
3.Secondary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4
Hide Description Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.
Time Frame 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
ITT N= 93, OC analyzed n=89
ITT N= 181, OC analyzed n=176
Overall Number of Participants Analyzed 89 176
Mean (Standard Error)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure -0.3  (0.8) 3.8  (0.6)
Change in Diastolic Blood Pressure -0.3  (0.6) 4.2  (0.5)
4.Secondary Outcome
Title Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6
Hide Description Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.
Time Frame 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
ITT N=93, OC analyzed n=84
ITT N=181, OC analyzed n=162
Overall Number of Participants Analyzed 84 162
Mean (Standard Error)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure -0.4  (1.0) 5.0  (0.7)
Change in Diastolic Blood Pressure -0.5  (0.7) 5.0  (0.5)
5.Secondary Outcome
Title Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4
Hide Description Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.
Time Frame 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
ITT N= 93, OC analyzed n=89
ITT N= 181, OC analyzed n=176
Overall Number of Participants Analyzed 89 176
Mean (Standard Error)
Unit of Measure: bpm
Change in Heart Rate -1.0  (0.6) 11.7  (0.5)
6.Secondary Outcome
Title Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6
Hide Description Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.
Time Frame 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
ITT N=93, OC analyzed n=84
ITT N=181, OC analyzed n=162
Overall Number of Participants Analyzed 84 162
Mean (Standard Error)
Unit of Measure: bpm
Change in Heart Rate -1.6  (0.7) 12.9  (0.6)
Time Frame 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
Adverse Event Reporting Description For SAEs, 3 of 210 affected in double-blind treatment period & 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period & 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
 
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description ITT N= 93, OC analyzed n=89 Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
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   1/111 (0.90%)   6/210 (2.86%) 
Cardiac disorders     
Atrial Flutter  1  0/111 (0.00%)  1/210 (0.48%) 
Coronary Artery Stenosis  1  0/88 (0.00%)  1/164 (0.61%) 
Pericardial Effusion  1  0/88 (0.00%)  1/164 (0.61%) 
Gastrointestinal disorders     
Diarrhoea  1  0/88 (0.00%)  1/164 (0.61%) 
Hiatus Hernia  1  0/88 (0.00%)  1/164 (0.61%) 
Peritoneal Haemorrhage  1  0/88 (0.00%)  1/164 (0.61%) 
Vomiting  1  0/88 (0.00%)  1/164 (0.61%) 
General disorders     
Chest Pain  1  0/88 (0.00%)  1/164 (0.61%) 
Non-Cardiac Chest Pain  1  0/88 (0.00%)  1/164 (0.61%) 
Infections and infestations     
Periorbital Cellulitis  1  0/88 (0.00%)  1/164 (0.61%) 
Sinusitis  1  0/88 (0.00%)  1/164 (0.61%) 
Injury, poisoning and procedural complications     
Multiple Injuries  1  0/88 (0.00%)  1/164 (0.61%) 
Rib Fracture  1  0/88 (0.00%)  1/164 (0.61%) 
Road traffic accident  1  0/88 (0.00%)  1/164 (0.61%) 
Spelnic Rupture  1  0/88 (0.00%)  1/164 (0.61%) 
Wrist Fracture  1  0/88 (0.00%)  1/164 (0.61%) 
Nervous system disorders     
Complicated Migraine  1  1/111 (0.90%)  0/210 (0.00%) 
Reproductive system and breast disorders     
Uterine Haemorrhage  1  0/111 (0.00%)  1/210 (0.48%) 
Vascular disorders     
Hypertensive Crisis  1  0/111 (0.00%)  1/210 (0.48%) 
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%
Placebo Milnacipran
Affected / at Risk (%) Affected / at Risk (%)
Total   42/111 (37.84%)   117/210 (55.71%) 
Cardiac disorders     
Tachycardia  1  1/111 (0.90%)  20/210 (9.52%) 
Palpitations  1  3/111 (2.70%)  14/210 (6.67%) 
Gastrointestinal disorders     
Nausea  1  11/111 (9.91%)  48/210 (22.86%) 
Constipation  1  1/111 (0.90%)  23/210 (10.95%) 
Vomiting  1  2/111 (1.80%)  16/210 (7.62%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  9/111 (8.11%)  8/210 (3.81%) 
Urinary Tract Infection  1  7/111 (6.31%)  7/210 (3.33%) 
Musculoskeletal and connective tissue disorders     
Fibromyalgia  1  6/111 (5.41%)  7/210 (3.33%) 
Nervous system disorders     
Headache  1  5/111 (4.50%)  28/210 (13.33%) 
Dizziness  1  2/111 (1.80%)  16/210 (7.62%) 
Psychiatric disorders     
Insomnia  1  9/111 (8.11%)  12/210 (5.71%) 
Vascular disorders     
Hot Flush  1  2/111 (1.80%)  13/210 (6.19%) 
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.
Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
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: 201-427-8218
EMail: robert.palmer@frx.com
Layout table for additonal information
Responsible Party: Allan Spera, Director, Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00618956     History of Changes
Other Study ID Numbers: MLN-MD-12
First Submitted: January 31, 2008
First Posted: February 20, 2008
Results First Submitted: July 29, 2009
Results First Posted: September 3, 2009
Last Update Posted: November 20, 2009