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Norepinephrine Reuptake Inhibitor

Ampreloxetine for Multiple System Atrophy (CYPRESS Trial)

Phase 3
Recruiting
Research Sponsored by Theravance Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If participant is female, the participant must not be pregnant, breastfeeding, or planning a pregnancy during the course of the study. A woman of childbearing potential must have a documented negative pregnancy test at screening.
Participant must score at least a 4 on the OHSA item 1 at Visit 2 (Day 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-week randomized withdrawal period (week 12 to week 20)
Awards & highlights

CYPRESS Trial Summary

This trial studies how well a drug helps treat Multiple System Atrophy with a form of dizziness. It has 4 steps and lasts 20 weeks.

Who is the study for?
Adults over 30 with Multiple System Atrophy (MSA) and symptomatic neurogenic orthostatic hypotension (nOH), confirmed by specific criteria. Participants must not be pregnant, agree to use effective birth control, and cannot have certain cardiovascular conditions or recent substance abuse. Those on certain medications for nOH or with severe cognitive impairment are excluded.Check my eligibility
What is being tested?
The trial is testing Ampreloxetine's effectiveness in treating low blood pressure due to MSA compared to a placebo. It includes an initial open label phase where everyone gets the drug, followed by a randomized withdrawal period to see if benefits last without it, and then long-term treatment.See study design
What are the potential side effects?
While the side effects of Ampreloxetine aren't detailed here, similar drugs can cause headaches, dizziness upon standing (due to blood pressure changes), digestive issues like constipation or diarrhea, heart rate changes, and potential allergic reactions.

CYPRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.
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I scored at least a 4 on a specific health assessment.
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My blood pressure drops significantly when I stand up.
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I am at least 30 years old.
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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.
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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.
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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.
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I have been diagnosed with MSA, either Parkinsonian or cerebellar type.

CYPRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-week randomized withdrawal period (week 12 to week 20)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week randomized withdrawal period (week 12 to week 20) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in OHSA composite score at Week 8 during the double-blind RW period
Secondary outcome measures
Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization
Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization

CYPRESS Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Long-Term Extension PeriodActive Control1 Intervention
Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 104 weeks.
Group II: Ampreloxetine (Open Label)Active Control1 Intervention
Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 12 weeks.
Group III: Ampreloxetine (Randomized Withdrawal)Placebo Group2 Interventions
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.

Find a Location

Who is running the clinical trial?

Theravance BiopharmaLead Sponsor
73 Previous Clinical Trials
8,517 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
34 Patients Enrolled for Multiple System Atrophy

Media Library

Ampreloxetine (Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05696717 — Phase 3
Multiple System Atrophy Research Study Groups: Ampreloxetine (Randomized Withdrawal), Long-Term Extension Period, Ampreloxetine (Open Label)
Multiple System Atrophy Clinical Trial 2023: Ampreloxetine Highlights & Side Effects. Trial Name: NCT05696717 — Phase 3
Ampreloxetine (Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696717 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the US Food & Drug Administration sanctioned a Long-Term Extension Period?

"The safety of the Long-Term Extension Period has been judged as a 3, owing to its Phase 3 trial status and existing efficacy data. Additionally, there are numerous studies that attest to its security."

Answered by AI

Is this medical experiment actively looking for participants?

"As seen on clinicaltrials.gov, recruitment for this medical trial is ongoing; the first post was made on March 1st 2023 and most recently updated on March 30th of the same year."

Answered by AI

How many volunteers are being recruited for this trial?

"Affirmative. According to information available on clinicaltrials.gov, this medical experiment was first published on March 1st 2023 and is actively enrolling participants at the moment. The study requires 102 individuals from a single trial location."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
NYU Langone Health NYU Dysautonomia Center
Science 37
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~48 spots leftby Dec 2024