Fibromyalgia
Conditions
Brief summary
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.
Interventions
DRUGplacebo
Part A: Placebo every 12 hours for 4 weeks
DRUGAGN 203818
Part A: AGN 203818 3 mg every 12 hours for 4 weeks
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia syndrome * Moderate or severe pain associated with fibromyalgia
Exclusion criteria
* Any other uncontrolled disease * Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Baseline, 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Baseline, 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. |
| Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Baseline, 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. |
| Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | 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. |
Countries
Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Part A: Placebo every 12 hours for 4 weeks | 53 |
| AGN 203818 3 mg Part A: 3 mg AGN 203818 every 12 hours for 4 weeks | 53 |
| AGN 203818 20 mg Part A: 20 mg AGN 203818 every 12 hours for 4 weeks | 52 |
| AGN 203818 60 mg Part A: 60 mg AGN 203818 every 12 hours for 4 weeks | 53 |
| Total | 211 |
Baseline characteristics
| Characteristic | Placebo | AGN 203818 3 mg | AGN 203818 20 mg | AGN 203818 60 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.5 years | 50.0 years | 49.5 years | 51.0 years | 50.0 years |
| Sex: Female, Male Female | 53 Participants | 53 Participants | 52 Participants | 53 Participants | 211 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 52 | 37 / 53 | 34 / 52 | 38 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 | 1 / 52 | 2 / 52 |
Outcome results
Primary
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).
Time frame: Baseline, Week 4
Population: Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Baseline | 6.7 Scores on a Scale | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Change from Baseline at Week 4 | -1.3 Scores on a Scale | Standard Deviation 1.66 |
| AGN 203818 3 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Change from Baseline at Week 4 | -1.2 Scores on a Scale | Standard Deviation 1.82 |
| AGN 203818 3 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Baseline | 6.7 Scores on a Scale | Standard Deviation 1.1 |
| AGN 203818 20 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Baseline | 6.6 Scores on a Scale | Standard Deviation 0.96 |
| AGN 203818 20 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Change from Baseline at Week 4 | -1.5 Scores on a Scale | Standard Deviation 1.79 |
| AGN 203818 60 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Baseline | 6.7 Scores on a Scale | Standard Deviation 1.14 |
| AGN 203818 60 mg | Change From Baseline in Mean Daily-Average-Pain Score at Week 4 | Change from Baseline at Week 4 | -1.5 Scores on a Scale | Standard Deviation 1.85 |
Secondary
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.
Time frame: Baseline, Week 4
Population: Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Baseline | 59.9 Scores on a Scale | Standard Deviation 15.35 |
| Placebo | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from Baseline at Week 4 | -13.3 Scores on a Scale | Standard Deviation 16.67 |
| AGN 203818 3 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from Baseline at Week 4 | -15.1 Scores on a Scale | Standard Deviation 18.17 |
| AGN 203818 3 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Baseline | 65.5 Scores on a Scale | Standard Deviation 15.55 |
| AGN 203818 20 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Baseline | 65.7 Scores on a Scale | Standard Deviation 13.63 |
| AGN 203818 20 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from Baseline at Week 4 | -18.7 Scores on a Scale | Standard Deviation 20.51 |
| AGN 203818 60 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Baseline | 63.0 Scores on a Scale | Standard Deviation 13.44 |
| AGN 203818 60 mg | Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 | Change from Baseline at Week 4 | -12.8 Scores on a Scale | Standard Deviation 20.41 |
Secondary
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.
Time frame: Baseline, Week 4
Population: Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from Baseline at Week 4 | -1.3 Scores on a Scale | Standard Deviation 1.88 |
| Placebo | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Baseline | 6.4 Scores on a Scale | Standard Deviation 1.19 |
| AGN 203818 3 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Baseline | 6.6 Scores on a Scale | Standard Deviation 1.21 |
| AGN 203818 3 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from Baseline at Week 4 | -1.2 Scores on a Scale | Standard Deviation 1.79 |
| AGN 203818 20 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Baseline | 6.5 Scores on a Scale | Standard Deviation 1.23 |
| AGN 203818 20 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from Baseline at Week 4 | -1.7 Scores on a Scale | Standard Deviation 2.24 |
| AGN 203818 60 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Change from Baseline at Week 4 | -1.3 Scores on a Scale | Standard Deviation 1.68 |
| AGN 203818 60 mg | Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 | Baseline | 6.5 Scores on a Scale | Standard Deviation 1.28 |
Secondary
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.
Time frame: Week 4
Population: Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Improved | 69.8 Percentage of Patients |
| Placebo | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Worse | 11.6 Percentage of Patients |
| Placebo | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | No Change | 18.6 Percentage of Patients |
| AGN 203818 3 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Improved | 67.4 Percentage of Patients |
| AGN 203818 3 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Worse | 10.9 Percentage of Patients |
| AGN 203818 3 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | No Change | 21.7 Percentage of Patients |
| AGN 203818 20 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | No Change | 23.8 Percentage of Patients |
| AGN 203818 20 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Improved | 69.1 Percentage of Patients |
| AGN 203818 20 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Worse | 7.1 Percentage of Patients |
| AGN 203818 60 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Improved | 69.1 Percentage of Patients |
| AGN 203818 60 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | Worse | 11.9 Percentage of Patients |
| AGN 203818 60 mg | Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 | No Change | 19.0 Percentage of Patients |