Efficacy and Safety of IGN-ES001 in Chronic Widespread Pain With or Without Fibromyalgia

Inclusion Criteria: 1. Male or female out-patient ≥ 18 years and ≤ 70 years of age. 2. Patient willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of investigational product, subjective completion of diaries and questionnaires, attending scheduled visits, completing telephone interviews, and compliant with protocol requirements as evidenced by providing signed writteninformed consent. 3. History of chronic widespread pain (for at least three months prior to visit V1 (screening)). 4. a.) For FM patients: Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI 3-6 and SS ≥ 9 (original preliminary fibromyalgia criteria of the American College of Rheumatology (ACR) 2010). b.) For non-FM CWP patients: WPI ≥ 3-6 and SS ≥ 5-8 (modified from the preliminary fibromyalgia criteria of the ACR 2010). 5. Use of prior and concomitant medications/ therapies (if not excluded, see exclusion criteria no 6 and no 7), non-pharmacological therapies and lifestyle habits (e.g. diet changes, Ramadan participation, etc.) that could influence the efficacy assessments must have been stable for at least 30 days prior to visit V1 (screening) and are anticipated to be at a stable regimen throughout the trial until visit V9. 6. Patient has negative urine test at screening visit V1 for the following drugs of abuse: 1. Amphetamine 2. Cocaine 3. Metamphetamine 4. Morphine 5. Tetrahydrocannabinol 7. Female patient is surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least two years postmenopausal or, if of childbearing potential, she is sexually abstinent or agrees to practice adequate contraceptive measures (hormonal contraceptives, intrauterine device, double-barrier method). 8. Patient must have completed at least 6 screening phase diary pages satisfactorily within the past 7 days before visit V2. 9. Median pain NRS must be ≥ 4 in at least 1 out of the 6 pain qualities and ≥ 4 in overall pain assessment. The median will be calculated from the last 7 days before visit V2 (baseline) and will serve as baseline value. If all inclusion criteria are fulfilled (and none of the exclusion criteria below), the patient will be randomized at visit V2 and continues in the trial. Otherwise the patient will be excluded from trial participation. Exclusion Criteria: 1. Patients without a basic and stable CWP therapy which started at least 30 days before V1 (screening) i.e. treatment-n…