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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE November 22, 2006
Results First Submitted Date  ICMJE September 22, 2009
Results First Posted Date  ICMJE October 22, 2009
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE October 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • 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 ]
    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 ]
    The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2006)
Average Daily Pain Score using an 11 point Lickert Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Official Title  ICMJE 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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia Syndrome
Intervention  ICMJE
  • 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
  • Other: Placebo
    Matching placebo tablet administered twice daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Lacosamide
    Lacosamide Tablet 400mg daily
    Intervention: Drug: Lacosamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2009)
159
Original Enrollment  ICMJE
 (submitted: November 20, 2006)
160
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401830
Other Study ID Numbers  ICMJE SP0887
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UCB Pharma
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE UCB Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP