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

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ClinicalTrials.gov Identifier: NCT00401830
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : October 22, 2009
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia Syndrome
Interventions Drug: Lacosamide
Other: Placebo
Enrollment 159
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description Matching placebo tablet (administered twice daily) Lacosamide Tablet 400mg daily (administered twice daily)
Period Title: Overall Study
Started 81 78
Completed 50 46
Not Completed 31 32
Reason Not Completed
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
Arm/Group Title Placebo Lacosamide Total
Hide Arm/Group Description Matching placebo tablet (administered twice daily) Lacosamide Tablet 400mg daily (administered twice daily) Total of all reporting groups
Overall Number of Baseline Participants 81 78 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 159 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
79
  97.5%
76
  97.4%
155
  97.5%
>=65 years
2
   2.5%
2
   2.6%
4
   2.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 78 participants 159 participants
50.4  (10.5) 48.9  (11.1) 49.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 159 participants
Female
77
  95.1%
71
  91.0%
148
  93.1%
Male
4
   4.9%
7
   9.0%
11
   6.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 78 participants 159 participants
81 78 159
1.Primary Outcome
Title 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)
Hide Description The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.30  (1.92) -1.80  (2.13)
2.Primary Outcome
Title 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)
Hide Description The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 36 41
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-2.11  (1.98) -2.40  (2.08)
3.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Hide Description The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 79 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-14.7  (16.9) -17.5  (19.3)
4.Secondary Outcome
Title Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Hide Description Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 79 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-6.7  (13.6) -9.7  (13.0)
5.Secondary Outcome
Title Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.24  (1.94) -1.64  (2.16)
6.Secondary Outcome
Title Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
Time Frame Baseline, Last 2 weeks of the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.27  (1.93) -1.44  (2.30)
7.Secondary Outcome
Title Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12 week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.29  (1.97) -1.77  (2.18)
8.Secondary Outcome
Title Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Hide Description An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline, Last 2 weeks of the 12 week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.32  (1.94) -1.84  (2.15)
9.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
Hide Description The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 67 67
Measure Type: Number
Unit of Measure: Patients
Much better 8 17
Moderately better 14 12
Mildly better 18 13
No change 17 13
Mildly worse 5 3
Moderately worse 2 6
Much worse 3 3
10.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Depression score (Placebo n=67, Lacosamide n=67) -1.1  (2.8) -0.8  (2.8)
Anxiety Score (Placebo n=67, Lacosamide n=66) -1.2  (3.2) -1.2  (3.2)
11.Secondary Outcome
Title Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
Hide Description Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
Time Frame 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Measure Type: Number
Unit of Measure: Percentage of patients
83.8 83.3
12.Secondary Outcome
Title Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
Hide Description Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
Time Frame 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 80 78
Measure Type: Number
Unit of Measure: Percentage of patients
17.5 15.4
13.Secondary Outcome
Title Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
Hide Description All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
Time Frame Baseline, Last assessment in the 12-week Treatment Phase
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Muscular Pain -1.9  (2.4) -2.4  (2.9)
Fatigue -1.7  (2.4) -1.9  (2.9)
Insomnia -1.9  (2.7) -2.4  (3.2)
Joint pains -1.9  (2.8) -1.9  (3.3)
Headaches -0.7  (3.2) -1.2  (3.5)
Restless legs -1.5  (2.9) -1.2  (3.3)
Paresthesias -1.6  (2.6) -1.3  (3.1)
Impaired memory -1.3  (2.7) 0.0  (3.1)
Leg cramps -1.5  (2.8) -1.4  (2.8)
Impaired concentration -1.2  (3.1) -0.5  (3.1)
Abdominal pain, alternating diarrhea/constipation -1.7  (3.4) -1.2  (3.5)
14.Secondary Outcome
Title Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Hide Description [Not Specified]
Time Frame End of the Maintenance Phase/Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description:
Matching placebo tablet (administered twice daily)
Lacosamide Tablet 400mg daily (administered twice daily)
Overall Number of Participants Analyzed 0 45
Mean (Standard Deviation)
Unit of Measure: ug/ML
9.44  (5.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lacosamide
Hide Arm/Group Description Matching placebo tablet (administered twice daily) Lacosamide Tablet 400mg daily (administered twice daily)
All-Cause Mortality
Placebo Lacosamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Lacosamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/81 (3.70%)      0/78 (0.00%)    
Infections and infestations     
Gastroenteritis * 1  1/81 (1.23%)  1 0/78 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/81 (1.23%)  1 0/78 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/81 (1.23%)  1 0/78 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  1/81 (1.23%)  1 0/78 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lacosamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/81 (45.68%)      53/78 (67.95%)    
Eye disorders     
Vision blurred * 1  1/81 (1.23%)  1 4/78 (5.13%)  5
Gastrointestinal disorders     
Constipation * 1  3/81 (3.70%)  3 5/78 (6.41%)  5
Diarrhoea * 1  6/81 (7.41%)  7 5/78 (6.41%)  5
Hypoaesthesia oral * 1  0/81 (0.00%)  0 4/78 (5.13%)  4
Nausea * 1  12/81 (14.81%)  13 13/78 (16.67%)  15
Vomiting * 1  4/81 (4.94%)  4 5/78 (6.41%)  6
General disorders     
Fatigue * 1  5/81 (6.17%)  6 4/78 (5.13%)  4
Infections and infestations     
Nasopharyngitis * 1  5/81 (6.17%)  5 3/78 (3.85%)  3
Sinusitis * 1  4/81 (4.94%)  4 4/78 (5.13%)  4
Musculoskeletal and connective tissue disorders     
Back pain * 1  2/81 (2.47%)  3 4/78 (5.13%)  5
Pain in extremity * 1  0/81 (0.00%)  0 4/78 (5.13%)  4
Nervous system disorders     
Balance disorder * 1  0/81 (0.00%)  0 4/78 (5.13%)  4
Dizziness * 1  8/81 (9.88%)  9 18/78 (23.08%)  21
Headache * 1  18/81 (22.22%)  20 16/78 (20.51%)  16
Somnolence * 1  3/81 (3.70%)  3 5/78 (6.41%)  5
Psychiatric disorders     
Anxiety * 1  4/81 (4.94%)  4 4/78 (5.13%)  4
Skin and subcutaneous tissue disorders     
Pruritus * 1  2/81 (2.47%)  2 7/78 (8.97%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
[Not Specified]
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.
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00401830    
Other Study ID Numbers: SP0887
First Submitted: November 9, 2006
First Posted: November 22, 2006
Results First Submitted: September 22, 2009
Results First Posted: October 22, 2009
Last Update Posted: July 18, 2018