Fibromyalgia syndrome in female patients MedDRA version: 9.1 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome
Conditions
Interventions
Product Name: AGN 203818
Product Code: 9697X
Pharmaceutical Form: Capsule*
INN or Proposed INN: (+)-4-(S)-[1-(2,3-Dimethyl-phenyl)-ethyl]-1,3-dihydro-imidazole-2-thione
CAS Number: NA
Current Sponsor
Sponsors
Allergan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent and data protection consent has been obtained. - Female patients 18 to 75. - Patient has fibromyalgia syndrome (FMS) as defined by the American College of Rheumatatology (1990) criteria. - FMS is the patient's primary painful condition. - Patient has pain associated with FMS defined according to the 11 point Likert scale. - WOCBP must have a negative pregnancy test at screening. - Patient is acceptable for enrollment as determined by the investigator from the screening procedures. - Patient must be able to understand and co-operate with the study requirements and instructions and be willing and able to complete all study visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Anticipated change or recent initiation of pharmacological or non-pharmacological therapies for FMS. - Use of any prohibited medications prior to baseline visit. - Patient using herbal supplements and not on a stable and regular dose for at least 4 weeks prior to baseline. - Uncontrolled concurrent disease other than FMS. - Positive test for hepatitis B, hepatitis C or HIV virus antibodies at screening. - Thyroid function test results that are considered unacceptable. - Thyroidectomy or radio-iodine therapy for hyperthyroidism with 12 months of baseline. - History of rheumatoid arthritis, inflammatory arthritis, autoimmune disease associated with pain or other significant painful conditions that may confound the study. - Previous or current diagnosis of manic or hypomanic episode (bipolar disorder) or psychotic disorder, including current or lifetime diagnosis of these diagnostic categories identified by the Mini- International Neuropsychiatric Interview (MINI) - Current diagnosis of a major depressive episode, dysthymic disorder, or generalised anxiety disorder irrespective of whether the disorder is currently controlled by pharmacological treatment, including any of the above listed diagnostic categories or a moderate or high suicidal risk, identified by the MINI, or at risk of self-harm. - Score greater than or equal to 2 on question 9 (suicide) of the Beck Depression Inventory at baseline, or at risk of self-harm. - Clinically significant hypotension (including symptomatic orthostatic). - History of significant allergic condition including severe drug-related hypersensitivity (e.g. anaphylactic reaction) - Known allergy or sensitivity to any compound or chemical class related to AGN 203818 or its excipients. - Previously participated in an AGN 203818 study. - History of treatment for or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 2 units per day. - Current enrollment in another IP or device study. - WOCP who is not using a double-barrier method of contraception. - Pregnancy, nursing, or planning a pregnancy. - Anticipated need for surgery or hospitalisation during the study. - Currently applying for disability allowance or have ongoing litigation activities related to their medical condition. - A condition or situation which may put the patient at significant risk, may confound the study results or interfere significantly with participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of AGN 203818 oral capsules administered twice-daily as compared with placebo in female patients with fibromyalgia syndrome.;Secondary Objective: ;Primary end point(s): Primary efficacy measurement: - Daily-average-pain score (11 Likert Scale) from the patient diary. Secondary efficacy measures: - Daily-worst-pain score (11 point Likert Scale) from the patient diary. - Incidence of responders by various percentages of reduction from baseline in mean daily-average-pain-score. - Short Form Brief Pain Inventory and Short Form McGill Pain questionnaire - Use of rescue medication for pain associated with FMS - 18 point Dolorimetry measurement to provide mean pressure pain threshold and tenderpoint count. - Fibromyalgia Impact Questionnaire. - Subject Global Impression of Change for FMS. - Medical Outcome Study Sleep scale and Jenkins Sleep Evaluation Questionnaire. - Daily-sleep-interference score (11 point Likert Scale). - Multidimensional Assessment of Fatigue and daily-fatigue-score (11 point Likert). - Beck Depression and Anxiety Inventory and Profile of Mood States. - SF-36 Health Surveys and Work Productivity and Activity Impairment Questionnaire. - For migraine sufferers a Subject Global assessment of Change for headache severity and frequency and duration. | — |
Countries
Germany, United Kingdom
Outcome results
None listed