Trial Outcomes & Findings for A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (NCT NCT00440518)
NCT ID: NCT00440518
Last Updated: 2018-07-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
Baseline, Entire 14-week Maintenance Period
Results posted on
2018-07-17
Participant Flow
A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Randomized /Titration Period
STARTED
|
72
|
72
|
74
|
|
Randomized /Titration Period
COMPLETED
|
59
|
63
|
70
|
|
Randomized /Titration Period
NOT COMPLETED
|
13
|
9
|
4
|
|
Maintenance and Safety Follow-up Periods
STARTED
|
59
|
63
|
70
|
|
Maintenance and Safety Follow-up Periods
COMPLETED
|
52
|
51
|
55
|
|
Maintenance and Safety Follow-up Periods
NOT COMPLETED
|
7
|
12
|
15
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Randomized /Titration Period
Lack of Efficacy
|
1
|
0
|
1
|
|
Randomized /Titration Period
Subject Withdrew Consent
|
4
|
1
|
0
|
|
Randomized /Titration Period
Protocol Deviation
|
1
|
0
|
0
|
|
Randomized /Titration Period
Unsatisfactory Compliance
|
2
|
3
|
2
|
|
Randomized /Titration Period
Other
|
1
|
0
|
0
|
|
Randomized /Titration Period
Lost to Follow-up
|
2
|
2
|
1
|
|
Randomized /Titration Period
Adverse Event
|
2
|
3
|
0
|
|
Maintenance and Safety Follow-up Periods
Adverse Event
|
3
|
4
|
2
|
|
Maintenance and Safety Follow-up Periods
Lack of Efficacy
|
0
|
1
|
1
|
|
Maintenance and Safety Follow-up Periods
Subject Withdrew Consent
|
3
|
2
|
4
|
|
Maintenance and Safety Follow-up Periods
Unsatisfactory Compliance
|
0
|
3
|
6
|
|
Maintenance and Safety Follow-up Periods
Other
|
0
|
0
|
2
|
|
Maintenance and Safety Follow-up Periods
Lost to Follow-up
|
1
|
2
|
0
|
Baseline Characteristics
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Baseline characteristics by cohort
| Measure |
Placebo
n=72 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=72 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
218 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 12.23 • n=99 Participants
|
40.1 years
STANDARD_DEVIATION 11.86 • n=107 Participants
|
40.2 years
STANDARD_DEVIATION 11.40 • n=206 Participants
|
39.9 years
STANDARD_DEVIATION 11.78 • n=157 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
187 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
31 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=99 Participants
|
72 participants
n=107 Participants
|
74 participants
n=206 Participants
|
218 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline, Entire 14-week Maintenance PeriodPopulation: Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=70 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
|
-1.4 Number of migraine headaches
Standard Deviation 3.12
|
-1.4 Number of migraine headaches
Standard Deviation 2.68
|
-1.6 Number of migraine headaches
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline, last 4 weeks of the 14-week Maintenance PeriodPopulation: Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=70 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period
|
-1.3 Number of migraine headaches
Standard Deviation 3.45
|
-1.3 Number of migraine headaches
Standard Deviation 2.82
|
-1.7 Number of migraine headaches
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline, Entire 14-week Maintenance PeriodPopulation: Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=70 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.
|
26 Participants
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline, last 4 weeks of the 14-week Maintenance PeriodPopulation: Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=70 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
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.
|
27 Participants
|
27 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline, last visit in the 17-week Trial PeriodPopulation: Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.
Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=66 Participants
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=66 Participants
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
|
-3.8 Scores on a scale
Standard Deviation 7.78
|
-4.3 Scores on a scale
Standard Deviation 8.67
|
-3.5 Scores on a scale
Standard Deviation 8.03
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Lacosamide 100mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Lacosamide 300mg
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=72 participants at risk
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=72 participants at risk
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 participants at risk
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/72
|
0.00%
0/72
|
1.4%
1/74 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72
|
1.4%
1/72 • Number of events 1
|
0.00%
0/74
|
|
Hepatobiliary disorders
Gallbladder disorder
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
0.00%
0/74
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/72
|
0.00%
0/72
|
1.4%
1/74 • Number of events 2
|
|
Infections and infestations
Viral infection
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
0.00%
0/74
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
0.00%
0/74
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1
|
0.00%
0/72
|
0.00%
0/74
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/72
|
1.4%
1/72 • Number of events 1
|
0.00%
0/74
|
Other adverse events
| Measure |
Placebo
n=72 participants at risk
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 100mg
n=72 participants at risk
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
Lacosamide 300mg
n=74 participants at risk
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
5/72 • Number of events 5
|
5.6%
4/72 • Number of events 8
|
5.4%
4/74 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
9.7%
7/72 • Number of events 9
|
6.9%
5/72 • Number of events 5
|
4.1%
3/74 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/72 • Number of events 4
|
1.4%
1/72 • Number of events 1
|
0.00%
0/74
|
|
General disorders
Fatigue
|
1.4%
1/72 • Number of events 1
|
6.9%
5/72 • Number of events 5
|
14.9%
11/74 • Number of events 12
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
7/72 • Number of events 7
|
16.7%
12/72 • Number of events 12
|
14.9%
11/74 • Number of events 13
|
|
Infections and infestations
Influenza
|
6.9%
5/72 • Number of events 5
|
4.2%
3/72 • Number of events 3
|
5.4%
4/74 • Number of events 4
|
|
Infections and infestations
Bronchitis
|
0.00%
0/72
|
2.8%
2/72 • Number of events 2
|
5.4%
4/74 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
1.4%
1/72 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
4.1%
3/74 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
5/72 • Number of events 6
|
9.7%
7/72 • Number of events 9
|
1.4%
1/74 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
4/72 • Number of events 4
|
2.8%
2/72 • Number of events 2
|
2.7%
2/74 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
5.6%
4/72 • Number of events 6
|
6.9%
5/72 • Number of events 6
|
2.7%
2/74 • Number of events 4
|
|
Nervous system disorders
Headache
|
6.9%
5/72 • Number of events 11
|
4.2%
3/72 • Number of events 9
|
2.7%
2/74 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
2/72 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
5.4%
4/74 • Number of events 4
|
Additional Information
Study Director
UCB Clinical Trial Call Center
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER