Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05696717 | Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy | PHASE3 | ACTIVE NOT_RECRUITING | 102 | — | — | Jun 27, 2023 | Jan 1, 2028 | Sep 5, 2025 | 79 | United States, Argentina +18 |
| NCT03750552 | Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | PHASE3 | COMPLETED | 195 | — | — | Jan 24, 2019 | Jul 21, 2021 | Sep 14, 2022 | 125 | United States, Australia +17 |
Score change from baseline on the composite of Questions 1 - 6 of the Orthostatic Hypotension Symptom Assessment (OHSA).
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
| Arm | Type | Description |
|---|---|---|
| Ampreloxetine (Open Label) | ACTIVE_COMPARATOR | Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 12 weeks. |
| Ampreloxetine (Randomized Withdrawal) | PLACEBO_COMPARATOR | After completing the open label, participants are randomized to either ampreloxetine or placebo receiving a single, oral, daily dose of active drug or placebo for a further 8 weeks. |
| Long-Term Extension Period | ACTIVE_COMPARATOR | Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 104 weeks. |
| ampreloxetine | EXPERIMENTAL | Participants randomized to ampreloxetine will receive a single, oral, daily dose of active drug for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to Placebo will receive a single, oral, daily dose of placebo for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Ampreloxetine | DRUG | Oral tablet, QD |
| Placebo | DRUG | Oral tablet, QD |
Inclusion Criteria: * Participant is male or female and at least 30 years old. * Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008). * Participant has a diagnosis of possible or probable M...