A Phase 3 22-week Multi-center Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Brief description of study

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of TD-9855 in subjects with primary autonomic failures (MSA, PD, or PAF) and snOH. Eligible subjects are either (i) completers of Study 0169 (0169 Completers Group), or (ii) snOH subjects meeting all applicable study inclusion criteria and none of the applicable exclusion criteria (De Novo Group). The study consists of 3 periods: (i) 16-week open-label (OL) treatment with TD-9855, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171). A 2-week screening period will apply to the De Novo Group only.

Clinical Study Identifier: s18-02094
ClinicalTrials.gov Identifier: NCT03750552
Principal Investigator: Jose Alberto Palma Carazo.

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