{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T09:51:44Z","timestamp":1777888304943,"version":"3.51.4"},"reference-count":0,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2014,1,1]],"date-time":"2014-01-01T00:00:00Z","timestamp":1388534400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Parkinson\u2019s Disease"],"published-print":{"date-parts":[[2014,2,1]]},"abstract":"<jats:p>Background: Neurogenic orthostatic hypotension (nOH) is common in Parkinson's disease (PD), and represents a failure to generate norepinephrine responses appropriate for postural change. Droxidopa (L-threo-3,4-dihydroxyphenylserine) is an oral norepinephrine prodrug. Objective: Interim analyses of the initial patients enrolled in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of droxidopa for nOH in PD (ClinicalTrials.gov Identifier: NCT01176240). Methods: PD patients with documented nOH underwent \u22642 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment (100\u2013600 mg t.i.d.). The primary efficacy measure was change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to Week 8. Key secondary variables included dizziness\/lightheadedness score (OHQ item 1) and patient-reported falls. Results: Among 24 droxidopa and 27 placebo recipients, mean OHQ composite-score change at Week 8 was \u22122.2 versus \u22122.1 (p = 0.98); in response to this pre-planned futility analysis, the study was temporarily stopped and all data from these patients were considered exploratory. At Week 1, mean dizziness\/lightheadedness score change favored droxidopa by 1.5 units (p = 0.24), with subsequent numerical differences favoring droxidopa throughout the observation period, and at Week 1, mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg (p = 0.04). Compared with placebo, the droxidopa group exhibited an approximately 50% lower rate of reported falls (p = 0.16) and fall-related injuries (post-hoc analysis). Conclusions: This exploratory analysis of a small dataset failed to show benefit of droxidopa, as compared with placebo by the primary endpoint. Nonetheless, there were signals of potential benefit for nOH, including improvement in dizziness\/lightheadedness and reduction in falls, meriting evaluation in further trials.<\/jats:p>","DOI":"10.3233\/jpd-130259","type":"journal-article","created":{"date-parts":[[2019,12,3]],"date-time":"2019-12-03T14:07:04Z","timestamp":1575382024000},"page":"57-65","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":82,"title":["Droxidopa in Patients with Neurogenic Orthostatic Hypotension                     Associated with Parkinson's Disease (NOH306A)"],"prefix":"10.1177","volume":"4","author":[{"given":"Robert A.","family":"Hauser","sequence":"first","affiliation":[{"name":"University of South Florida, Tampa, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L. Arthur","family":"Hewitt","sequence":"additional","affiliation":[{"name":"Chelsea Therapeutics, Inc., Charlotte, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart","family":"Isaacson","sequence":"additional","affiliation":[{"name":"Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca\r                    Raton, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,1,1]]},"container-title":["Journal of Parkinson\u2019s Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3233\/JPD-130259","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3233\/JPD-130259","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T04:42:37Z","timestamp":1777610557000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3233\/JPD-130259"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,1,1]]},"references-count":0,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2014,2,1]]}},"alternative-id":["10.3233\/JPD-130259"],"URL":"https:\/\/doi.org\/10.3233\/jpd-130259","relation":{"is-cited-by":[{"id-type":"doi","id":"10.12688\/f1000research.10100.1","asserted-by":"object"}]},"ISSN":["1877-7171","1877-718X"],"issn-type":[{"value":"1877-7171","type":"print"},{"value":"1877-718X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,1,1]]}}}