Trial Outcomes & Findings for Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome (NCT NCT00445705)

Last Updated: 2015-09-07

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

211 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2015-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Overall Study STARTED	53	53	52	53
Overall Study COMPLETED	44	42	41	39
Overall Study NOT COMPLETED	9	11	11	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=53 Participants Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=53 Participants Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=52 Participants Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=53 Participants Part A: 60 mg AGN 203818 every 12 hours for 4 weeks	Total n=211 Participants Total of all reporting groups
Age, Continuous	50.5 years n=99 Participants	50.0 years n=107 Participants	49.5 years n=206 Participants	51.0 years n=7 Participants	50.0 years n=31 Participants
Sex: Female, Male Female	53 Participants n=99 Participants	53 Participants n=107 Participants	52 Participants n=206 Participants	53 Participants n=7 Participants	211 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=51 Participants Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=50 Participants Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=50 Participants Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Change From Baseline in Mean Daily-Average-Pain Score at Week 4 Baseline	6.7 Scores on a Scale Standard Deviation 1.04	6.7 Scores on a Scale Standard Deviation 1.10	6.6 Scores on a Scale Standard Deviation 0.96	6.7 Scores on a Scale Standard Deviation 1.14
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	-1.2 Scores on a Scale Standard Deviation 1.82	-1.5 Scores on a Scale Standard Deviation 1.79	-1.5 Scores on a Scale Standard Deviation 1.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=51 Participants Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=50 Participants Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=50 Participants Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
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	6.6 Scores on a Scale Standard Deviation 1.21	6.5 Scores on a Scale Standard Deviation 1.23	6.5 Scores on a Scale Standard Deviation 1.28
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	-1.2 Scores on a Scale Standard Deviation 1.79	-1.7 Scores on a Scale Standard Deviation 2.24	-1.3 Scores on a Scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=51 Participants Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=50 Participants Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=50 Participants Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
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	65.5 Scores on a Scale Standard Deviation 15.55	65.7 Scores on a Scale Standard Deviation 13.63	63.0 Scores on a Scale Standard Deviation 13.44
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	-15.1 Scores on a Scale Standard Deviation 18.17	-18.7 Scores on a Scale Standard Deviation 20.51	-12.8 Scores on a Scale Standard Deviation 20.41

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=51 Participants Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=50 Participants Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=50 Participants Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 Improved	69.8 Percentage of Patients	67.4 Percentage of Patients	69.1 Percentage of Patients	69.1 Percentage of Patients
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 No Change	18.6 Percentage of Patients	21.7 Percentage of Patients	23.8 Percentage of Patients	19.0 Percentage of Patients
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 Worse	11.6 Percentage of Patients	10.9 Percentage of Patients	7.1 Percentage of Patients	11.9 Percentage of Patients

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

AGN 203818 3 mg

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

AGN 203818 20 mg

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

AGN 203818 60 mg

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=52 participants at risk Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=53 participants at risk Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=52 participants at risk Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=52 participants at risk Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Gastrointestinal disorders Pancreatitis	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Gastrointestinal disorders Gastric ulcer	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.

Other adverse events

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=52 participants at risk Part A: Placebo every 12 hours for 4 weeks	AGN 203818 3 mg n=53 participants at risk Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 20 mg n=52 participants at risk Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	AGN 203818 60 mg n=52 participants at risk Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Gastrointestinal disorders Dry Mouth	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	15.4% 8/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Gastrointestinal disorders Nausea	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	15.1% 8/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	13.5% 7/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Gastrointestinal disorders Diarrhoea	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.5% 4/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Gastrointestinal disorders Dyspepsia	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	5.7% 3/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
General disorders Fatigue	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.5% 4/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.7% 4/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
General disorders Oedema peripheral	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	3.8% 2/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Infections and infestations Upper respiratory tract infection	9.6% 5/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.4% 5/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.7% 4/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Infections and infestations Nasopharyngitis	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.4% 5/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	3.8% 2/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Infections and infestations Urinary tract infection	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Nervous system disorders Headache	13.5% 7/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	24.5% 13/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	17.3% 9/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	25.0% 13/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Nervous system disorders Dizziness	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	9.4% 5/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	13.5% 7/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	17.3% 9/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Nervous system disorders Somnolence	1.9% 1/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.5% 4/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	7.7% 4/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	11.5% 6/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
Nervous system disorders Migraine	5.8% 3/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	5.7% 3/53 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.	0.00% 0/52 The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.