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

Study Overview
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Brief Summary
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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.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: placebo
* Drug: AGN 203818
* Drug: AGN 203818
* Drug: AGN 203818


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of fibromyalgia syndrome Moderate or severe pain associated with fibromyalgia Exclusion Criteria: Any other uncontrolled disease Pregnant or nursing females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Part A: Placebo every 12 hours for 4 weeks | Drug: placebo<br>* Part A: Placebo every 12 hours for 4 weeks<br>|
| Experimental: AGN 203818 3 mg<br>Part A: 3 mg AGN 203818 every 12 hours for 4 weeks | Drug: AGN 203818<br>* Part A: AGN 203818 3 mg every 12 hours for 4 weeks<br>|
| Experimental: AGN 203818 20 mg<br>Part A: 20 mg AGN 203818 every 12 hours for 4 weeks | Drug: AGN 203818<br>* Part A: AGN 203818 20 mg every 12 hours for 4 weeks<br>|
| Experimental: AGN 203818 60 mg<br>Part A: 60 mg AGN 203818 every 12 hours for 4 weeks | Drug: AGN 203818<br>* Part A: AGN 203818 60 mg every 12 hours for 4 weeks<br>|

What is the study measuring?
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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 |