Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: placebo; Drug: AGN 203818; Drug: AGN 203818; Drug: AGN 203818

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
• United Kingdom
  • Stanmore, United Kingdom
• United States
  • Ohio
    • Canton, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of fibromyalgia syndrome
• Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

• Any other uncontrolled disease
• Pregnant or nursing females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Part A: Placebo every 12 hours for 4 weeks	Drug: placebo; Part A: Placebo every 12 hours for 4 weeks
Experimental: AGN 203818 3 mg; Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN 203818; Part A: AGN 203818 3 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 20 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 60 mg every 12 hours for 4 weeks
Experimental: AGN 203818 20 mg; Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN 203818; Part A: AGN 203818 3 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 20 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 60 mg every 12 hours for 4 weeks
Experimental: AGN 203818 60 mg; Part A: 60 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN 203818; Part A: AGN 203818 3 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 20 mg every 12 hours for 4 weeks; Drug: AGN 203818; Part A: AGN 203818 60 mg every 12 hours for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Daily-Average-Pain Score at Week 4	Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4	Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The "average pain" question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.	Baseline, Week 4
Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4	Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.	Baseline, Week 4
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4	PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: "improved"= score of 1-3; "no change"=score of 4; and "worse"=score of 5-7.	Week 4

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: March 7, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (Estimate): March 9, 2007

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 203818-503