drugset / Trial / NCT02705755
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
RandomizedParallel-groupSingle-blindTreatment
Summary
This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance.
Timeline
- Start
- 2017-09-09
- Primary completion
- 2018-07-24
- Completion
- 2018-11-28
Publications
- Kaufmann H, Vickery R, Wang W, Kanodia J, Shibao CA, Norcliffe-Kaufmann L, Haumann B, Biaggioni I. Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial. Clin Auton Res. 2021 Dec;31(6):699-711. doi: 10.1007/s10286-021-00827-0. Epub 2021 Oct 17.
- Lo A, Norcliffe-Kaufmann L, Vickery R, Bourdet D, Kanodia J. Pharmacokinetics and pharmacodynamics of ampreloxetine, a novel, selective norepinephrine reuptake inhibitor, in symptomatic neurogenic orthostatic hypotension. Clin Auton Res. 2021 Jun;31(3):395-403. doi: 10.1007/s10286-021-00800-x. Epub 2021 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ampreloxetine | Small molecule | 1 mg | Oral |
| Subject | ampreloxetine | Small molecule | 2.5 mg | Oral |
| Subject | ampreloxetine | Small molecule | 5 mg | Oral |
| Subject | ampreloxetine | Small molecule | 10 mg | Oral |
| Subject | ampreloxetine | Small molecule | 15 mg | Oral |
| Subject | ampreloxetine | Small molecule | 20 mg | Oral |