CLINICAL TRIALS PROFILE FOR AMPRELOXETINE
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Clinical Trials for ampreloxetine
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03750552 ↗ | Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | Completed | Theravance Biopharma | Phase 3 | A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment. |
| NCT03829657 ↗ | Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | Active, not recruiting | Theravance Biopharma | Phase 3 | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure |
| NCT04095793 ↗ | Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | Active, not recruiting | Theravance Biopharma | Phase 3 | A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks. |
| NCT04200573 ↗ | Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855 | Completed | Theravance Biopharma | Phase 1 | An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function. |
| NCT04688632 ↗ | Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects | Completed | Theravance Biopharma | Phase 1 | A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects. |
| NCT05696717 ↗ | Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy | Not yet recruiting | Theravance Biopharma | Phase 3 | 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). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for ampreloxetine
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Clinical Trial Locations for ampreloxetine
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Clinical Trial Progress for ampreloxetine
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Clinical Trial Sponsors for ampreloxetine
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