Trials / Terminated
TerminatedNCT03829657
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Detailed description
Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)).
Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- MSA
- Parkinson's Disease (PD)
- Pure Autonomic Failure (PAF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ampreloxetine | Oral tablet, QD (Daily) |
| DRUG | Placebo | Oral tablet, QD |
Timeline
- Start date
- 2019-02-22
- Primary completion
- 2021-11-10
- Completion
- 2021-11-10
- First posted
- 2019-02-04
- Last updated
- 2023-01-20
- Results posted
- 2023-01-20
Locations
82 sites across 19 countries: United States, Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03829657. Inclusion in this directory is not an endorsement.