Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05696717
Other study ID # 2022-003903-14
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 27, 2023
Est. completion date January 2027

Study information

Verified date June 2024
Source Theravance Biopharma
Contact Theravance Biopharma
Phone 1-855-633-8479
Email medinfo@theravance.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ampreloxetine
Oral tablet, QD
Placebo
Oral tablet, QD

See more »

Sponsors (1)

Lead Sponsor Collaborator
Theravance Biopharma

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Denmark,  Estonia,  France,  Germany,  Hungary,  Italy,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in OHSA composite score at Week 8 during the double-blind RW period Score change from baseline on the composite of Questions 1 - 6 of the Orthostatic Hypotension Symptom Assessment (OHSA). 8-week randomized withdrawal period (Week 12 to Week 20)
Secondary Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization Orthostatic Hypotension Daily Activities Scale (OHDAS) is an assessment of how low blood pressure symptoms affect daily life. 8-week randomized withdrawal period (Week 12 to Week 20)
Secondary Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization Orthostatic Hypotension Daily Activities Scale (OHDAS) is an assessment of how low blood pressure symptoms affect daily life. 8-week randomized withdrawal period (Week 12 to Week 20)
See also
  Status Clinical Trial Phase
Recruiting NCT02194816 - Modifiable Variables in Parkinsonism (MVP)
Recruiting NCT05698017 - Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early- to Moderate Stage MSA Phase 1/Phase 2
Enrolling by invitation NCT04680130 - Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders
Recruiting NCT05486806 - Longitudinal Tracking of Patients Diagnosed With Neurodegenerative Movement Disorders
Completed NCT03577483 - Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis N/A
Recruiting NCT02795052 - Neurologic Stem Cell Treatment Study N/A
Recruiting NCT05197816 - MotIoN aDaptive Deep Brain Stimulation for MSA N/A
Not yet recruiting NCT06120049 - [18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DBL vs. AD Phase 2/Phase 3
Completed NCT05011773 - Manipulating and Optimising Brain Rhythms for Enhancement of Sleep N/A
Recruiting NCT05792332 - Integrated Management of Atypical Parkinsonism: A Home-based Patient-Centered Healthcare Delivery Based on Telenursing (IMPACT Study) N/A