E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fibromyalgia syndrome in female patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016631 |
E.1.2 | Term | Fibromyalgia syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and efficacy of AGN 203818 oral capsules administered twice-daily as compared with placebo in female patients with fibromyalgia syndrome. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |