A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00440518

First received: February 23, 2007

Last updated: September 19, 2014

Last verified: September 2011

History of Changes

Results First Received: August 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Migraine
Interventions:	Drug: Lacosamide Other: 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
A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects on stable dose of prophylactic medication entered a 2-week Wash-Out Period followed by a 4-week Baseline Period without any prophylactic medication. Subjects not taking prophylactic medication entered the Baseline Period directly for 6 weeks. Subjects entered a 3-week Titration Period and if completed entered a 14-week Maintenance Period.

Reporting Groups

	Description
Placebo	Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg	Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg	Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Participant Flow for 2 periods

Period 1: Randomized /Titration Period

	Placebo	Lacosamide 100mg	Lacosamide 300mg
STARTED	72	72	74
COMPLETED	59	63	70
NOT COMPLETED	13	9	4
Lack of Efficacy	1	0	1
Subject Withdrew Consent	4	1	0
Protocol Deviation	1	0	0
Unsatisfactory Compliance	2	3	2
Other	1	0	0
Lost to Follow-up	2	2	1
Adverse Event	2	3	0

Period 2: Maintenance and Safety Follow-up Periods

	Placebo	Lacosamide 100mg	Lacosamide 300mg
STARTED	59	63	70
COMPLETED	52	51	55
NOT COMPLETED	7	12	15
Adverse Event	3	4	2
Lack of Efficacy	0	1	1
Subject Withdrew Consent	3	2	4
Unsatisfactory Compliance	0	3	6
Other	0	0	2
Lost to Follow-up	1	2	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	Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg	Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg	Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Total	Total of all reporting groups

Baseline Measures

	Placebo	Lacosamide 100mg	Lacosamide 300mg	Total
Overall Participants Analyzed [Units: Participants]	72	72	74	218

Age [Units: Participants]
<=18 years	0	0	0	0
Between 18 and 65 years	72	72	74	218
>=65 years	0	0	0	0

Age [Units: Years] Mean (Standard Deviation)	39.3 (12.23)	40.1 (11.86)	40.2 (11.40)	39.9 (11.78)

Gender [Units: Participants]
Female	62	62	63	187
Male	10	10	11	31

Region of Enrollment [Units: Participants]
United States	72	72	74	218

Outcome Measures

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1. Primary:

Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

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2. Secondary:

Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

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3. Secondary:

Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

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4. Secondary:

Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period. [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

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5. Secondary:

Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) [ Time Frame: Baseline, last visit in the 17-week Trial Period ]

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Serious Adverse Events

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Other Adverse Events

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Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Placebo	Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg	Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg	Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Other Adverse Events

	Placebo	Lacosamide 100mg	Lacosamide 300mg
Total, Other (not including serious) Adverse Events
# participants affected / at risk	30/72 (41.67%)	36/72 (50.00%)	33/74 (44.59%)
Gastrointestinal disorders
Diarrhoea ^* 1
# participants affected / at risk	5/72 (6.94%)	4/72 (5.56%)	4/74 (5.41%)
# events	5	8	5
Nausea ^* 1
# participants affected / at risk	7/72 (9.72%)	5/72 (6.94%)	3/74 (4.05%)
# events	9	5	4
Vomiting ^* 1
# participants affected / at risk	4/72 (5.56%)	1/72 (1.39%)	0/74 (0.00%)
# events	4	1	0
General disorders
Fatigue ^* 1
# participants affected / at risk	1/72 (1.39%)	5/72 (6.94%)	11/74 (14.86%)
# events	1	5	12
Infections and infestations
Nasopharyngitis ^* 1
# participants affected / at risk	7/72 (9.72%)	12/72 (16.67%)	11/74 (14.86%)
# events	7	12	13
Influenza ^* 1
# participants affected / at risk	5/72 (6.94%)	3/72 (4.17%)	4/74 (5.41%)
# events	5	3	4
Bronchitis ^* 1
# participants affected / at risk	0/72 (0.00%)	2/72 (2.78%)	4/74 (5.41%)
# events	0	2	4
Sinusitis ^* 1
# participants affected / at risk	1/72 (1.39%)	4/72 (5.56%)	3/74 (4.05%)
# events	1	4	3
Upper respiratory tract infection ^* 1
# participants affected / at risk	5/72 (6.94%)	7/72 (9.72%)	1/74 (1.35%)
# events	6	9	1
Musculoskeletal and connective tissue disorders
Back pain ^* 1
# participants affected / at risk	4/72 (5.56%)	2/72 (2.78%)	2/74 (2.70%)
# events	4	2	2
Nervous system disorders
Dizziness ^* 1
# participants affected / at risk	4/72 (5.56%)	5/72 (6.94%)	2/74 (2.70%)
# events	6	6	4
Headache ^* 1
# participants affected / at risk	5/72 (6.94%)	3/72 (4.17%)	2/74 (2.70%)
# events	11	9	4
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain ^* 1
# participants affected / at risk	2/72 (2.78%)	3/72 (4.17%)	4/74 (5.41%)
# events	2	3	4

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 11.1

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:	NCT00440518 History of Changes
Other Study ID Numbers:	SP0906
Study First Received:	February 23, 2007
Results First Received:	August 3, 2009
Last Updated:	September 19, 2014

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