A multicenter, multiple dose, double-blind, randomized, placebo-controlled, parallel group study of the safety and efficacy of AGN 203818 in female patients with fibromyalgia syndrome.
- Conditions
- Fibromyalgia syndrome in female patientsMedDRA version: 9.1Level: LLTClassification code 10016631Term: Fibromyalgia syndrome
- Registration Number
- EUCTR2006-006100-11-DE
- Lead Sponsor
- Allergan Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 160
- 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 points Likert scale.
- WOCP 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method