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

This study has been completed.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00618956
First received: January 31, 2008
Last updated: November 10, 2009
Last verified: November 2009
Results First Received: July 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Milnacipran hydrochloride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was from October 15, 2007 to April 16, 2008 at 38 centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Placebo ITT N= 93, OC analyzed n=89
Milnacipran Milnacipran 100 to 200 mg/day tablet, oral administration, BID.

Participant Flow:   Overall Study
    Placebo     Milnacipran  
STARTED     111     210  
COMPLETED     86     160  
NOT COMPLETED     25     50  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
Milnacipran No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     Milnacipran     Total  
Number of Participants  
[units: participants]
  111     210     321  
Age  
[units: years]
Mean ± Standard Deviation
  48.9  ± 11.1     48.3  ± 10.9     48.5  ± 11.0  
Age, Customized  
[units: participants]
     
< 20 years     1     2     3  
20-59 years     91     174     265  
>= 60 years     19     34     53  
Gender  
[units: participants]
     
Female     109     198     307  
Male     2     12     14  
Region of Enrollment  
[units: participants]
     
United States     111     210     321  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4   [ Time Frame: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d) ]

2.  Primary:   Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6   [ 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) ]

3.  Secondary:   Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4   [ Time Frame: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d) ]

4.  Secondary:   Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6   [ 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) ]

5.  Secondary:   Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4   [ Time Frame: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d) ]

6.  Secondary:   Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6   [ 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Palmer, MD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
phone: 201-427-8218
e-mail: robert.palmer@frx.com


No publications provided by Forest Laboratories

Publications automatically indexed to this study:

Responsible Party: Allan Spera, Director, Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00618956     History of Changes
Other Study ID Numbers: MLN-MD-12
Study First Received: January 31, 2008
Results First Received: July 29, 2009
Last Updated: November 10, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional review board - Quorum