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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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.
No text entered.

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
Overall Participants Analyzed  [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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

11.  Secondary:

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

12.  Secondary:

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

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 ]

14.  Secondary:

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

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
No text entered.