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

Fibromyalgia Syndrome Clinical Trial

Official title:

A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401830
• Other study ID #: SP0887
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Description:

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males or females, 18 to 65 years old

• Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia

• At least moderate pain (pain intensity = 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)

• Fibromyalgia Impact Questionnaire (FIQ) total score = 50

• Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

• Symptomatic regional or structural rheumatic disease

• Diagnosed neuropathic pain syndrome

• Receiving treatment with neurostimulating devices

• Significant psychopathology

• History of chronic alcohol or drug abuse within 6 months prior to Screening

• Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening

• Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias

• Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)

• Other medical conditions that could compromise the subject's ability to participate in the study

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Signs and Symptoms
• Syndrome

Intervention

Drug:
• Lacosamide
Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg

Other:
• Placebo
Matching placebo tablet administered twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12-week Treatment Phase
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)	The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary	Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase	The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia	Baseline, Last assessment in the 12-week Treatment Phase
Secondary	Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase	Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.	Baseline, Last assessment in the 12-week Treatment Phase
Secondary	Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase	Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)	Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary	Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase	General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)	Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary	Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12 week Treatment Phase
Secondary	Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12 week Treatment Phase
Secondary	Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase	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]).	Baseline, Last assessment in the 12-week Treatment Phase
Secondary	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase	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.	Baseline, Last assessment in the 12-week Treatment Phase
Secondary	Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase	Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.	12-week Treatment Phase
Secondary	Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase	Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).	12-week Treatment Phase
Secondary	Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase	All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.	Baseline, Last assessment in the 12-week Treatment Phase
Secondary	Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12		End of the Maintenance Phase/Week 12

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