Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
Condition: Symptomatic Neurogenic Orthostatic Hypotension (NOH); Non-diabetic Neuropathy; Primary Autonomic Failure; Dopamine Beta Hydroxylase Deficiency
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Autonomic Nervous System Diseases; Hypotension
Intervention: Placebo; Droxidopa
Intervention description: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day; 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Intervention MeSH terms: Droxidopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NOH; Neurogenic Orthostatic Hypotension; Orthostatic hypotension; PAF; Pure Autonomic Failure; MSA; Multiple System Atrophy; Neuropathy; Autonomic Failure; Parkinson; Dopamine Deficiency; Dopamine; Droxidopa

Summary:

      The purpose of this study is to see whether droxidopa is effective in treating symptoms of
      neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic
      Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta
      Hydroxylase deficiency.
    

Eligibility criteria:

        PATIENT INCLUSION CRITERIA:

          -  Male or female and aged 18 years or over;

          -  Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic
             Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic
             Autonomic Neuropathies;

          -  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;

          -  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.

        MAIN PATIENT EXCLUSION CRITERIA:

          -  Taking ephedrine or midodrine; Patients taking ephedrine or midodrine may enroll after
             a minimum 7 day washout period;

          -  Taking anti-hypertensive medication;

          -  Have a history of more than moderate alcohol consumption;

          -  Women who are pregnant or lactating;

          -  Have a history of closed angle glaucoma;

          -  Have pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting
             position);

          -  Have atrial fibrillation or, in the investigator's opinion, have any other significant
             cardiac arrhythmia;

          -  In the investigator's opinion, have any other significant systemic, hepatic, cardiac
             or renal illness;

          -  Have diabetes mellitus or insipidus;

          -  Have a known or suspected malignancy;

          -  Have 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;

          -  Have a serum creatinine level > 130 µmol/L;