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History of Changes for Study: NCT00401830
A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
Latest version (submitted June 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 20, 2006 None (earliest Version on record)
2 February 23, 2007 Contacts/Locations and Study Status
3 June 25, 2007 Contacts/Locations, Study Status, Study Design and Study Identification
4 July 16, 2007 Contacts/Locations, Eligibility, Outcome Measures, Study Description, Study Status and Study Identification
5 July 18, 2007 Contacts/Locations, Outcome Measures, Study Description and Study Status
6 August 23, 2007 Contacts/Locations, Study Status and Study Design
7 October 8, 2007 Contacts/Locations and Study Status
8 October 10, 2007 Contacts/Locations and Study Status
9 December 18, 2007 Study Status
10 January 14, 2008 Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Study Identification
11 March 3, 2008 Recruitment Status, Study Status, Arms and Interventions, Study Design, Contacts/Locations and Outcome Measures
12 July 8, 2009 Outcome Measures, Arms and Interventions, Study Description, Study Status, Eligibility, Study Design, Conditions, Oversight and Study Identification
13 September 22, 2009 Outcome Measures, Study Status, Arms and Interventions, Results, Eligibility, Conditions and Study Description
14 November 6, 2009 Study Status, Outcome Measures, Participant Flow
15 December 23, 2009 More Information, Study Status and References
16 September 23, 2010 Study Status
17 August 30, 2011 Sponsor/Collaborators and Study Status
18 September 19, 2014 Outcome Measures, Baseline Characteristics, Study Status and Study Identification
19 July 28, 2017 Study Status, Outcome Measures, References and Contacts/Locations
20 June 20, 2018 Study Status
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Study NCT00401830
Submitted Date:  November 20, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: SP887
Brief Title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
Official Title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2006
Overall Status: Recruiting
Study Start: October 2006
Primary Completion:
Study Completion: November 2007
First Submitted: November 9, 2006
First Submitted that
Met QC Criteria:
November 20, 2006
First Posted: November 22, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 20, 2006
Last Update Posted: November 22, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: UCB Pharma
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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

After screening, the trial consists of 1 week Baseline Diary, 4 week Titration, 8 week double-blind Maintenance, 1 week Taper and 2 week Safety Follow-Up phases. Subjects are randomized to one of two treatment arms: lacosamide 400mg/day or placebo during the double-blind Maintenance phase.

The primary variable is the average daily pain score using an 11-point Likert scale.

The secondary variables include changes in Fibromyalgia Impact Questionnaire, total myalgic score, daily interference with sleep, daily interference with general activity, Patient Global Impression of Change, average morning/evening pain scores.

Other variables include: use of rescue medication, plasma concentrations of lacosamide, assessments of adverse events (including withdrawals), changes in Hospital Anxiety Depression Scale, fibromyalgia symptom checklist, laboratory parameters, vital signs, ECGs and physical examinations

Detailed Description:
Open or close this module Conditions
Conditions: Fibromyalgia Syndrome
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 160
Open or close this module Arms and Interventions
Intervention Details:
Drug: SPM 965 - Lacosamide
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Average Daily Pain Score using an 11 point Lickert Scale
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Subject must have signs and symptoms of idiopathic/primary fibromyalgia that is documented as lasting > 3 months
Open or close this module Contacts/Locations
Central Contact Person: Margaret Richardson
Email: margaret.richardson@schwarzbiosciences.com
Study Officials: Brooke Derby
Study Director
SCHWARZ
Locations: United States, North Carolina
SCHWARZ
[Recruiting]
Raleigh, North Carolina, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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