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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00401830
First received: November 9, 2006
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Fibromyalgia Syndrome
Drug: Lacosamide
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

  • 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 ] [ Designated as safety issue: No ]
    The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia

  • 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 ] [ Designated as safety issue: No ]
    Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.

  • 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 ] [ Designated as safety issue: No ]
    Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)

  • 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 ] [ Designated as safety issue: No ]
    General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)

  • 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 ] [ Designated as safety issue: No ]
    An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

  • 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 ] [ Designated as safety issue: No ]
    An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

  • 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 ] [ Designated as safety issue: No ]
    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]).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
    Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.

  • Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
    Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).

  • 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 ] [ Designated as safety issue: No ]
    All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.

  • Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Matching placebo tablet administered twice daily
Experimental: Lacosamide
Lacosamide Tablet 400mg daily
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 Names:
  • Vimpat
  • Harkoseride

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401830

  Show 25 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00401830     History of Changes
Other Study ID Numbers: SP887
Study First Received: November 9, 2006
Results First Received: September 22, 2009
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Fibromyalgia Syndrome
Lacosamide
Vimpat
Harkoseride

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014