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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Multiple System Atrophy
-
Age: Between 30 Year(s) - 100 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Participant must be willing to not take any prohibited medications during the study.
- 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.
- During the study and for 30 days after receiving the last dose of the study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures.
- Participant is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.
- Participant is able to communicate well with the Investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.
You may not be eligible for this study if the following are true:
-
- Participant has a systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Participant with diabetes will be evaluated on a case-by-case basis.
- Participant has a known intolerance to other norepinephrine reuptake inhibitors (NRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
- Participant currently uses concomitant antihypertensive medication for the treatment of essential hypertension.
- Participant has clinically unstable coronary artery disease or had a major cardiovascular event (e.g., myocardial infarction) in the past 6 months.
- Participant has significant uncontrolled cardiac arrhythmia, history of complete heart block, or significant QTc prolongation.
- Participant has a new onset of a neurological event (i.e., seizures, confusion, altered levels of consciousness, etc.) in the past 6 months.
- Participant is unable or unwilling to complete all protocol specified procedures including questionnaires.
- Participant has known congestive heart failure.
- Participant has had any malignant disease, other than carcinoma in situ of the cervix or basal cell carcinoma, within the past 2 years prior to Screening.
- Participant is currently receiving any investigational drug or has received an investigational drug within 30 days of dosing. An investigational drug is defined as a drug that is not approved by a regulatory agency (e.g., Food and Drug Administration [FDA]).
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.