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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504876-12-00

Acronym

0197

Enrollment

Registered

2023-08-11

Start date

2023-10-25

Completion date

Unknown

Last updated

2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Orthostatic Hypotension

Brief summary

The primary study efficacy endpoint is the change in OHSA composite score at Week 8 during the double-blind RW period (Visit 9, Day 141)

Detailed description

Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization (Visit 9, Day 141), Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization (Visit 9, Day 141)

Interventions

DRUGAMPRELOXETINE

DRUGAmpreloxetine tablets prepared with the same composition as IMP

DRUGexcept for the drug substance .

DRUGGutron® Tabletten 2

DRUG5 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary study efficacy endpoint is the change in OHSA composite score at Week 8 during the double-blind RW period (Visit 9, Day 141)	—

Secondary

Measure	Time frame
Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization (Visit 9, Day 141), Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization (Visit 9, Day 141)	—

Countries

Austria, Belgium, Denmark, Estonia, France, Germany, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026