Clinical trial NCT01176240 (phase 3, status: completed)
Conditions: orthostatic hypotension, parkinson's disease
ICD codes: I95.1, G20
Drugs: droxidopa
SMILES: N[C@@H]([C@H](O)C1=CC(O)=C(O)C=C1)C(O)=O
Eligibility criteria:

        Inclusion criteria:

          1. 18 years or over

          2. Clinical diagnosis of Parkinson's disease

          3. Clinical diagnosis of symptomatic neurogenic orthostatic hypotension

        At their baseline visit (Visit 2), patients must demonstrate:

          -  a score of at least 3 or greater on the OHQ composite

          -  a score of at least 3 or greater on the clinician CGI-S

          -  a fall of at least 20 mmHg in their systolic blood pressure, or 10 mmHg in their
             diastolic blood pressure, within 3 minutes of standing 4. 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

        Exclusion Criteria:

          1. Score of 23 or lower on the mini-mental state examination (MMSE)

          2. Concomitant use of vasoconstricting agents for the purpose of increasing blood
             pressure;

             - 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 baseline visit (Visit 2) and throughout the duration of the
             study

          3. Concomitant use of anti-hypertensive medication for the treatment of essential
             hypertension

          4. Have changed dose, frequency or type of prescribed medication, within two weeks of
             baseline visit (Visit 2) with the following exceptions:

               -  Vasoconstricting agents such a ephedrine, dihydroergotamine, or midodrine

               -  Short courses (less than 2 weeks) of medications or treatments that do not
                  interfere with, or exacerbate the patient's condition under study (e.g.
                  antibiotics)

          5. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV
             definition of alcohol or substance abuse)

          6. Women who are pregnant or breastfeeding

          7. Women of child bearing potential (WOCP) who are not using at least one method of
             contraception with their partner

          8. Male patients who are sexually active with a woman of child bearing potential (WOCP)
             and not using at least one method of contraception

          9. Untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion
             of an ophthalmologist, might result in an increased risk to the patient

         10. Sustained severe hypertension (BP ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic in the
             seated or supine position which is observed in 3 consecutive measurements over an
             hour)

         11. Any significant uncontrolled cardiac arrhythmia

         12. History of myocardial infarction, within the past 2 years

         13. Current unstable angina

         14. Congestive heart failure (NYHA Class 3 or 4)

         15. Diabetic autonomic neuropathy

         16. History of cancer within the past 2 years other than a successfully treated,
             non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in
             situ

         17. Gastrointestinal condition, which in the Investigator's judgment, may affect the
             absorption of study drug (e.g. ulcerative colitis, gastric bypass)

         18. Any major surgical procedure within 30 days of the baseline visit (Visit 2)

         19. Previously treated with droxidopa

         20. Currently receiving any investigational drug or have received an investigational drug
             within 30 days of the baseline visit (Visit 2)

         21. Any condition or laboratory test result, which in the Investigator's judgment, might
             result in an increased risk to the patient, or would affect their participation in the
             study. Additionally the Investigator has the ability to exclude a patient if for any
             reason they feel the subject is not a good candidate for the study or will not be able
             to follow study procedures.