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Ampreloxetine for Multiple System Atrophy (CYPRESS Trial)
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.
CYPRESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCYPRESS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CYPRESS Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 4 weeks.I do not have any health issues or recent surgeries that would affect my participation in the study.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I have severe heart failure (NYHA Class 3 or 4).I scored at least a 4 on a specific health assessment.I have an illness that can cause nerve damage but my diabetes is well-controlled without insulin, and I have no nerve, eye, or kidney issues.I have not had a heart attack or unstable heart disease in the last 6 months.Your Montreal Cognitive Assessment (MoCA) score is less than 21.I am taking medication for high blood pressure.I have not taken any MAOI drugs in the last 14 days.I am allergic or have had bad reactions to certain depression medications.I have abnormal blood tests that could affect my safety in the trial.I have experienced a new neurological issue, like seizures or confusion, in the last 6 months.You have had thoughts of harming yourself or have shown behaviors that indicate you might harm yourself.My blood pressure drops significantly when I stand up.I am at least 30 years old.I haven't had any cancer, except for cervical carcinoma in situ or basal cell carcinoma, in the last 2 years.I am not currently on, nor have I taken any experimental drugs in the last 30 days.I have serious heart rhythm problems or a long QT interval.I have stopped taking midodrine and droxidopa 7 days before my second visit.I am willing and able to follow all study requirements.I have been diagnosed with MSA, either Parkinsonian or cerebellar type.I am at least 30 years old.I have been diagnosed with MSA, either Parkinsonian or cerebellar type.Your UMSARS Part IV score at the first visit should be 4 or lower.I have recently changed my medication for low blood pressure upon standing.I haven't taken strong CYP1A2 affecting drugs recently.I have been diagnosed with MSA, either Parkinsonian or cerebellar type.I have been diagnosed with MSA, either Parkinsonian or cerebellar type.
- Group 1: Ampreloxetine (Randomized Withdrawal)
- Group 2: Long-Term Extension Period
- Group 3: Ampreloxetine (Open Label)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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