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NCT05696717 (Ampreloxetine in Symptomatic Neurogenic Orthostatic Hypotension MSA -…): BVCT ex-ante prediction vs. reported outcome

On 14 Nov 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 3 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05696717
Acronym
CYPRESS
Drug Name
Ampreloxetine
Drug MoA
norepinephrine reuptake inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Symptomatic Neurogenic Orthostatic Hypotension MSA - Multiple System Atrophy
Human Patients
102
Sponsor
Theravance Biopharma
Phase
Phase 3

Prediction of , index 2088

Prospective Prediction
Prediction Index
2088
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OHSA composite score moderately inferior to midodrine/droxidopa)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in OHSA composite score compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
109 days in advance
Readout Data Interpretation
ampreloxetine did not meet primary endpoint of OHSA composite score compared with placebo; well tolerated
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 3
Status
Active not recruiting
Enrollment
102
Lead sponsor
Theravance Biopharma
Conditions
Symptomatic Neurogenic Orthostatic Hypotension; MSA - Multiple System Atrophy
Interventions
DRUG: Ampreloxetine; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-06-27
Primary completion
2026-01
Completion
2028-01
Primary outcomes
  • Change in OHSA composite score at Week 8 during the double-blind RW period (8-week randomized withdrawal period (Week 12 to Week 20))

NCT05696717 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials