Treatment of pain associated with fibromyalgia MedDRA version: 9.1 Level: LLT Classification code 10048439 Term: Fibromyalgia
Conditions
Interventions
Trade Name: Dops
Product Name: Droxidopa capsules 200mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DROXIDOPA
CAS Number: 23
Sponsors
Chelsea Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients; • Aged at least 18 years; • Diagnosed with fibromyalgia as defined by the 1990 American College of Rheumatology (ACR) criteria. • Have a score between 20mm and 90mm on the Visual Analog Scale for Pain (VAS-P) section of the SF-MPQ at screening and baseline 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: • Currently taking any norepinephrine re-uptake inhibitors; • Currently taking tri-cyclic antidepressant medication; • Have uncontrolled hypertension; defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >110 mmHg or use of = 2 antihypertensive medications • Patients currently taking pregabalin unless they provide written informed consent and agree to discontinue pregabalin use 3 weeks prior to other screening procedures and for the duration of the study • Have clinically relevant depression noted as significant by Hamilton Depression Scale (HAM-D); • History of known or suspected drug or substance abuse; • Women of childbearing potential who are not using a medically accepted contraception; • Sexually active males whose partner is a WOCP who do not agree to use condoms for the duration of the study and for 4 weeks after the last dose; • Women who are pregnant, breast feeding, or plan to become pregnant during the course of this study; • Known or suspected hypersensitivity to the study medication or any of its ingredients; • Have in the investigator’s opinion any significant cardiac arrhythmia; • Any significant systemic, hepatic, cardiac or renal illness; • Diabetes mellitus or insipidus; • Have a history of closed angle glaucoma; • Have a known or suspected current malignancy. Patients with a history of cancer must be symptom- and treatment-free for at least 5 years prior to randomization, with the exception of patients with non-melanoma, non-invasive skin cancers (such as basal cell carcinoma), who should not have had an intervention or recurrence within one year of starting the study; • Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator’s opinion, affect the absorption of study drug; • In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing; • In the investigator’s opinion, are unable to adequately co-operate because of individual or family situation; • In the investigator’s opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia; • Are not able or willing to comply with the study requirements for the duration of the study; • Have participated in another clinical trial with an investigational agent (including named patient or compassionate use protocol) within 1 month before the start of the study; • Previous enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • Evaluate the effect of droxidopa and droxidopa/carbidopa on signs and symptoms of fibromyalgia (including depression, fatigue, sleep disorder) • Evaluate the effect of droxidopa and droxidopa/carbidopa on the overall quality of life of fibromyalgia patients • Evaluate the dose-response relationship for droxidopa between the doses of 200, 400, and 600mg TID or carbidopa 25 and 50mg TID and droxidopa/carbidopa TID in the treatment of fibromyalgia patients • Evaluate the clinical benefit of treatment with combination 200, 400, and 600mg droxidopa TID or 25 and 50mg carbidopa or droxidopa/carbidopa TID, in fibromyalgia patients • Estimate the optimal dose for relief of fibromyalgia pain using response surface methodology • Evaluate the safety of droxidopa and droxidopa/carbidopa treatments based on the occurrence of treatment-emergent adverse events (AE) and specific evaluation of blood pressure, heart rate, ECG, and laboratory findings across the study. ;Main Objective: Determine the efficacy of droxidopa and droxidopa/carbidopa in the treatment of pain associated with fibromyalgia; Primary end point(s): The primary measure of efficacy will be the improvement of pain as demonstrated by: • A decrease in the average pain score from baseline over 2 months of treatment according to Short-Form McGill Pain Questionnaire (SF-MPQ) | — |
Countries
United Kingdom
Outcome results
None listed