Trial record 1 of 1 for:
2018-003941-41
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (REDWOOD)
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| ClinicalTrials.gov Identifier: NCT03829657 |
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Recruitment Status :
Terminated
(Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.)
First Posted : February 4, 2019
Results First Posted : January 20, 2023
Last Update Posted : January 20, 2023
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Sponsor:
Theravance Biopharma
Information provided by (Responsible Party):
Theravance Biopharma
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Conditions |
Symptomatic Neurogenic Orthostatic Hypotension MSA Parkinson's Disease (PD) Pure Autonomic Failure (PAF) |
| Interventions |
Drug: ampreloxetine Drug: Placebo |
| Enrollment | 203 |
Participant Flow
| Recruitment Details | Participants were enrolled from February 2019 to November 2021. 203 participants were enrolled in the open label (OL) treatment period, including 170 participants from the 0169 study (NCT number: NCT03750552). 128 participants who completed the OL treatment period continued in the randomized withdrawal (RW) treatment period. |
| Pre-assignment Details |
| Arm/Group Title | OL Treatment Period: 0169 Placebo Rollover | OL Treatment Period: 0169 Ampreloxetine Rollover | OL Treatment Period: De Novo | RW Treatment Period: Placebo | RW Treatment Period: Ampreloxetine |
|---|---|---|---|---|---|
 Arm/Group Description |
Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks. | Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks. | Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study. | Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period. | Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period. |
| Period Title: OL Treatment Period (Week 1 to Week 16) | |||||
| Started | 85 | 85 | 33 | 0 | 0 |
| Completed | 52 | 64 | 12 | 0 | 0 |
| Not Completed | 33 | 21 | 21 | 0 | 0 |
| Reason Not Completed | |||||
| Adverse Event | 12 | 4 | 2 | 0 | 0 |
| Physician Decision | 1 | 0 | 0 | 0 | 0 |
| Study Terminated by Sponsor | 1 | 3 | 9 | 0 | 0 |
| Withdrawal by Subject | 6 | 7 | 5 | 0 | 0 |
| Failure to Meet Day 29 Continuation Criterion | 10 | 6 | 4 | 0 | 0 |
| Miscellaneous | 3 | 1 | 1 | 0 | 0 |
| Period Title: RW Treatment Period (Week 16 to Week 24) | |||||
| Started | 0 | 0 | 0 | 64 | 64 |
| Completed | 0 | 0 | 0 | 61 | 58 |
| Not Completed | 0 | 0 | 0 | 3 | 6 |
| Reason Not Completed | |||||
| Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Study Terminated by Sponsor | 0 | 0 | 0 | 2 | 3 |
| Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 |
| Miscellaneous | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | OL Treatment Period: 0169 Placebo Rollover | OL Treatment Period: 0169 Ampreloxetine Rollover | OL Treatment Period: De Novo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks. | Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks. | Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 83 | 85 | 32 | 200 | |
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Baseline Analysis Population Description |
OL Treatment Period Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 83 participants | 85 participants | 32 participants | 200 participants | |
| 68.2 (9.35) | 68.2 (9.00) | 69.0 (7.97) | 68.4 (8.96) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 85 participants | 32 participants | 200 participants | |
| Female |
22 26.5%
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30 35.3%
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8 25.0%
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60 30.0%
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| Male |
61 73.5%
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55 64.7%
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24 75.0%
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140 70.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 85 participants | 32 participants | 200 participants | |
| Hispanic or Latino |
2 2.4%
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4 4.7%
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0 0.0%
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6 3.0%
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| Not Hispanic or Latino |
77 92.8%
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76 89.4%
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32 100.0%
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185 92.5%
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| Unknown or Not Reported |
4 4.8%
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5 5.9%
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0 0.0%
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9 4.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 83 participants | 85 participants | 32 participants | 200 participants |
| White |
80 96.4%
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83 97.6%
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31 96.9%
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194 97.0%
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| Black or African American |
0 0.0%
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1 1.2%
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1 3.1%
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2 1.0%
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| Asian |
2 2.4%
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1 1.2%
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0 0.0%
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3 1.5%
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| Other |
1 1.2%
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0 0.0%
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0 0.0%
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1 0.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.
More Information
Results Point of Contact
| Name/Title: | Medical Monitor |
| Organization: | Theravance Biopharma Ireland Limited |
| Phone: | 855 633 8479 ext +1 |
| EMail: | medinfo@theravance.com |
| Responsible Party: | Theravance Biopharma |
| ClinicalTrials.gov Identifier: | NCT03829657 |
| Other Study ID Numbers: |
0170 2018-003941-41 ( EudraCT Number ) |
| First Submitted: | January 10, 2019 |
| First Posted: | February 4, 2019 |
| Results First Submitted: | November 8, 2022 |
| Results First Posted: | January 20, 2023 |
| Last Update Posted: | January 20, 2023 |