Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00401830

First received: November 9, 2006

Last updated: September 19, 2014

Last verified: December 2009

History of Changes

Results First Received: September 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Fibromyalgia Syndrome
Interventions:	Drug: Lacosamide Other: Placebo

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Matching placebo tablet (administered twice daily)
Lacosamide	Lacosamide Tablet 400mg daily (administered twice daily)

Participant Flow: Overall Study

	Placebo	Lacosamide
STARTED	81	78
COMPLETED	50	46
NOT COMPLETED	31	32
Adverse Event	10	18
Lack of Efficacy	11	5
Withdrawal by Subject	4	3
Protocol Violation	3	3
Non-compliance with drug study	1	0
Lost to Follow-up	1	3
Other: Personal / Family problems	1	0

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.
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Reporting Groups

	Description
Placebo	Matching placebo tablet (administered twice daily)
Lacosamide	Lacosamide Tablet 400mg daily (administered twice daily)
Total	Total of all reporting groups

Baseline Measures

	Placebo	Lacosamide	Total
Number of Participants [units: participants]	81	78	159
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	79	76	155
>=65 years	2	2	4
Age [units: years] Mean (Standard Deviation)	50.4 (10.5)	48.9 (11.1)	49.7 (10.8)
Gender [units: participants]
Female	77	71	148
Male	4	7	11
Region of Enrollment [units: participants]
United States	81	78	159

Outcome Measures

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1. Primary:

Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

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2. Primary:

Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set) [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

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3. Secondary:

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

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4. Secondary:

Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

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5. Secondary:

Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

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6. Secondary:

Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12-week Treatment Phase ]

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7. Secondary:

Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ]

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8. Secondary:

Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ]

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9. Secondary:

Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

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10. Secondary:

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

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11. Secondary:

Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ]

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12. Secondary:

Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ]

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13. Secondary:

Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ]

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14. Secondary:

Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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: UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Results Point of Contact:

Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
phone: +1 877 822 9493

Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT00401830 History of Changes
Other Study ID Numbers:	SP0887
Study First Received:	November 9, 2006
Results First Received:	September 22, 2009
Last Updated:	September 19, 2014
Health Authority:	United States: Food and Drug Administration

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