A Multi-Centre, Double-Blind, Placebo-Controlled, Parallel-Group Induction-Design Study to assess the Clinical Effect of Droxidopa in Subjects with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotensio

• Conditions: Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (Pharmacodynamic, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.

• Registration Number: EUCTR2008-002855-26-AT
• Lead Sponsor: Chelsea Therapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-21
• Last Update Posted: 10 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

a)Male or female and aged 18 years or over;

b)Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathies;

c)A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing;

d)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

a)Currently taking ephedrine or midodrine;
-Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days prior to their baseline visit (Visit 2).
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 re-uptake inhibitors;
d)Have changed dose, frequency and or type of prescribed medication, within two weeks of study start (excluding ephedrine and midodrine);
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 post-enopausal (amenorrhoea 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 serum beta HCG pregnancy test must be conducted at screening, and a urine pregnancy test must be conducted at baseline and study termination; the results must be negative at screening and at baseline for the patient to receive study medication.. 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)Have a serum creatinine level > 130 mmol/L;
r)Patients with known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator’s opinion, affect the absorption of study drug;
s)In the investigator’s opinion, have clinically significant abnormalities on clinical examination or laboratory testing;
t)In the investigator’s opinion, are unable to adequately co-operate because of individual or family situation;
u)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;
v)Are not able or willing to comply with the study requirements for the duration of the study;
w)Have participated in another clinical trial with an investigational agent (including named patient or compassionate use protocol) within

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified