Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
Condition Description
Neurogenic orthostatic hypotension (nOH) is a condition in which the autonomic system, which controls the automatic functions of the body, loses the ability to properly regulate blood pressure as one moves from sitting or lying down to standing, or when one changes positions quickly. As a result, patients with NOH suffer sudden and dangerous drops in blood pressure. The main symptoms of nOH include dizziness and visual disturbances. Fatigue, cognitive impairment, blurry vision, and difficulty breathing also occur as part of this condition. Symptoms may occur more often or more severely early in the morning, in hot weather, after large meals, or from prolonged standing. nOH is common in MSA, affecting about 75% of patients.
Active Trials
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TRIAL TITLE: A Phase 3, Multi-center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
DESCRIPTION: This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).
SPONSOR: Theravance Biopharma Ireland Limited
INDICATION: Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
STUDY PROTOCOL: 0197
PHASE: 3
STATUS: Active
RECRUITING PATIENTS: Yes