Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

This study has been completed.

Sponsor:

Collaborator:

Cypress Bioscience, Inc.

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01014585

First received: November 13, 2009

Last updated: September 2, 2011

Last verified: September 2011

History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Fibromyalgia
Interventions:	Drug: Placebo Drug: Milnacipran

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 November 2009 through February 2010 at 58 centers in the United States with the last patient visit occurring on June 7, 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Upon completion of a long term milnacipran open label study MLN-MD-06, patients were enrolled in the current study MLN-MD-27 (NCT01014585), and received open label treatment with milnacipran for four weeks prior to randomization.

Reporting Groups

	Description
Responders: Placebo (Milnacipran Withdrawn)	The Randomized Population for Responders
Responders: Milnacipran (Milnacipran Continued)	The Randomized Population for Responders
Non-Responders: Placebo (Milnacipran Withdrawn)	The Randomized Population for Non-Responders
Non-Responders: Milnacipran (Milnacipran Continued)	The Randomized Population for Non-Responders

Participant Flow: Overall Study

	Responders: Placebo (Milnacipran Withdrawn)	Responders: Milnacipran (Milnacipran Continued)	Non-Responders: Placebo (Milnacipran Withdrawn)	Non-Responders: Milnacipran (Milnacipran Continued)
STARTED	51	100	60	129
COMPLETED	31	75	37	99
NOT COMPLETED	20	25	23	30
Adverse Event	0	2	0	3
Withdrawal by Subject	2	0	1	3
Lost to Follow-up	0	0	0	2
Withdrawn Due to Worsening Fibromyalgia	18	23	22	22

Baseline Characteristics

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Reporting Groups

	Description
Responders: Placebo (Milnacipran Withdrawn)	Safety Population for Responders: placebo treatment assignment One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population.
Responders: Milnacipran (Milnacipran Continued)	Safety Population for Responders: milnacipran treatment assignment
Non-Responders: Placebo (Milnacipran Withdrawn)	Safety Population for Non-Responders: placebo treatment assignment
Non-Responders: Milnacipran (Milnacipran Continued)	Safety Population for Non-Responders: milnacipran treatment assignment One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population.
Total	Total of all reporting groups

Baseline Measures

	Responders: Placebo (Milnacipran Withdrawn)	Responders: Milnacipran (Milnacipran Continued)	Non-Responders: Placebo (Milnacipran Withdrawn)	Non-Responders: Milnacipran (Milnacipran Continued)	Total
Number of Participants [units: participants]	50	100	60	128	338
Age [units: years] Mean ± Standard Deviation	54.0 ± 8.3	54.5 ± 9.3	54.7 ± 9.6	54.8 ± 9.4	54.6 ± 9.2
Age, Customized [units: Years]
Between 20 and 60 years	39	73	38	86	236
>=60 years	11	27	22	42	102
Gender [units: participants]
Female	48	96	59	122	325
Male	2	4	1	6	13
Region of Enrollment [units: participants]
United States	50	100	60	128	338

Outcome Measures

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1. Primary:

Time to Loss of Therapeutic Response (LTR) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]

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2. Secondary:

Time to Worsening in Patient Global Impression of Change (PGIC) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]

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3. Secondary:

Time to Worsening in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]

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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: All data generated in this study is the property of Forest Research Institute, Inc. An integrated clinical and statistical report was prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

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
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Results Point of Contact:

Name/Title: Joel Trugman, MD
Organization: Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc.
phone: 201-427-8681
e-mail: joel.trugman@frx.com

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01014585 History of Changes
Other Study ID Numbers:	MLN-MD-27
Study First Received:	November 13, 2009
Results First Received:	June 7, 2011
Last Updated:	September 2, 2011
Health Authority:	United States: Food and Drug Administration

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