Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (PD, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.
Conditions
Interventions
Trade Name: DOPS
Product Name: Droxidopa
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DROXIDOPA
CAS Number: 23651958
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Chelsea Therapeutics Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Demonstrated a symptomatic response (an improvement of at least 1 point in Item #1 of the OHSA) to treatment with Droxidopa during open-label titration in Droxidopa 302 protocol b) Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care. 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: a) Currently taking vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine; - Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their study entry visit (Visit 1). b) Currently taking anti-hypertensive medication -The use of short-acting anti-hypertensive medications at bedtime is permitted; c) Currently taking tri-cyclic antidepressant medication or other norepinephrine reuptake inhibitors; d) Have changed dose, frequency and or type of prescribed medication, within two weeks of study entry visit (Visit 1) with the following exceptions: - vasoconstricting agents such as ephedrine, dihydroergotamine or midodrine (see exclusion a), -short courses of or other medications/treatments that do not interfere with, or exacerbate the patients's condition under study e) History of more than moderate alcohol consumption; f) History of known or suspected drug or substance abuse; g) Women of childbearing potential who are not using a medically accepted contraception; • Reproductive potential: Female subjects should be either postmenopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) who are using or agree to use acceptable methods of contraception. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. • For WOCP a urine pregnancy test must be conducted at each study visit. WOCP must be advised to use acceptable contraceptives throughout the study period and for 30 days after the last dose of investigational product. If hormonal contraceptives are used they should be taken according to the package insert. WOCP who are not currently sexually active must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of the study and for 30 days after the last dose of investigational product. h) Sexually active males whose partner is a WOCP and who do not agree to use condoms for the duration of the study and for 30 days after the last dose; i) Women who are pregnant or breast feeding; j) Known or suspected hypersensitivity to the study medication or any of its ingredients; k) Pre-existing sustained severe hypertension (BP = 180/110 mmHg in the sitting position); l) Have atrial fibrillation or, in the investigator’s opinion, have any other significant cardiac arrhythmia; m) Any other significant systemic, hepatic, cardiac or renal illness; n) Diabetes mellitus or insipidus; o) Have a history of closed angle glaucoma; p) Have a known or suspected malignancy; q) Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator’s opinion, affect the absorption of study drug; r) In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing; s) In the investigator’s opinion, are unable to adequately co-operate because of individual or family situation; t) 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; u) Are not able or willing to comply with the study requirements for the durat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the long-term safety of droxidopa in patients with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension (NOH), as measured by: - The occurrence of treatment-emergent adverse events and specific evaluation of blood pressure, heart rate, ECG, and laboratory findings across the study. ;Secondary Objective: • To evaluate the long-term clinical benefit of droxidopa in patients with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or non-diabetic neuropathy and symptomatic neurogenic orthostatic hypotension (NOH), as measured by: - The relative change in mean score of Item 1 of the Orthostatic Hypotension Symptom Assessment (OHSA) 14 days following randomization to continued therapy with droxidopa or placebo after 3 months of open-label treatment with droxidopa; - Symptom and activity measurements using the scores of OHSA, OHDAS; - Assessment of blood pressure during orthostatic challenge tests. ;Primary end point(s): Safety: • The occurrence of treatment-emergent adverse events and specific evaluations of blood pressure, heart rate, ECG, and laboratory findings across the study. Clinical benefit: • Mean change in OH symptoms, using Item 1 of the OHSA, between droxidopa and placebo treated patients (randomized withdrawal portion of study); • Symptom and activity measurements using the scores of OHSA, OHDAS; • Assessment of blood pressure during orthostatic challenge testing. | — |
Countries
Poland, United Kingdom
Outcome results
None listed