A PHASE II, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RESPONSE, STUDY TO ASSESS THE CLINICAL BENEFIT OF DROXIDOPA AND DROXIDOPA/CARBIDOPA IN SUBJECTS WITH FIBROMYALGIA
- Conditions
- Treatment of pain associated with fibromyalgiaMedDRA version: 9.1 Level: LLT Classification code 10048439 Term: Fibromyalgia
- Registration Number
- EUCTR2008-001123-62-GB
- Lead Sponsor
- Chelsea Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
•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
•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.
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