Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00797797

First received: November 24, 2008

Last updated: January 20, 2011

Last verified: January 2011

History of Changes

Results First Received: November 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Fibromyalgia
Interventions:	Drug: No Treatment Added Drug: Milnacipran Added

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
Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.

Reporting Groups

	Description
No Treatment Added	No treatment added for 11 weeks of randomized treatment period
Milnacipran Added	Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period

Participant Flow: Overall Study

	No Treatment Added	Milnacipran Added
STARTED	178 ^[1]	184
COMPLETED	123	141
NOT COMPLETED	55	43

[1]	Two patients took no background stable dose of pregabalin after randomization and are not included.

Baseline Characteristics

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Reporting Groups

	Description
No Treatment Added	No treatment added for 11 weeks of randomized treatment period
Milnacipran Added	Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
Total	Total of all reporting groups

Baseline Measures

	No Treatment Added	Milnacipran Added	Total
Number of Participants [units: participants]	178	184	362
Age [units: participants]
Between 18 and 60 years	151	146	297
>=60 years	27	38	65
Age [units: years] Mean ± Standard Deviation	48.8 ± 10.4	49.8 ± 10.3	49.3 ± 10.3
Gender [units: participants]
Female	159	170	329
Male	19	14	33
Region of Enrollment [units: participants]
United States	178	184	362

Outcome Measures

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1. Primary:

Patient Global Impression of Change (PGIC) Responder Rate at End of Study [ Time Frame: End of Randomized treatment period (11 weeks) ]

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2. Secondary:

Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study [ Time Frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Robert Palmer, MD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
phone: 1-201-427-8218
e-mail: robert.palmer@frx.com

No publications provided

Responsible Party:	James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
ClinicalTrials.gov Identifier:	NCT00797797 History of Changes
Other Study ID Numbers:	MLN-MD-15
Study First Received:	November 24, 2008
Results First Received:	November 18, 2010
Last Updated:	January 20, 2011
Health Authority:	United States: Food and Drug Administration

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