A Phase 3 4-week Multicenter Randomized Double-blind Placebo-controlled Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Neurogenic Orthostatic Hypotension
  • Age: Between 30 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must be at least 30 years old
    2. Female subjects must be nonpregnant and nonlactating. A woman of childbearing potential must have a documented negative pregnancy test at screening.
    3. Subjects who are sexually active must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after the last study medication dose.
    4. Male subjects should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with TD-9855 and for 1 month after the last dose to avoid exposing an embryo or fetus to TD-9855.
    5. Subjects must meet the diagnostic criteria of Symptomatic Neurogenic Orthostatic Hypotension (snOH), as demonstrated by a =20 mm Hg (systolic) or =10 mm Hg (diastolic) within 3 minutes of being tilted-up to =60° from a supine position as determined by a tilt-table test.
    6. Subjects must score at least a 4 on the Orthostatic Hypotension Symptom Assessment Question #1 at randomization visit
    7. For subjects with PD only: Subjects have a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).
    8. For subjects with MSA only: Subject 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).
    9. For subjects with PAF only: Subject has impaired autonomic reflexes, as determined by absence of Phase IV BP overshoot after release of the Valsalva strain.
    10. Subjects have plasma NE levels >100 pg/mL after being in seated position for 30 minutes.
    11. Subjects are willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures
    12. Subjects are 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:

    1. Subjects have known systemic illness known to produce autonomic neuropathy, including but not limited to diabetes mellitus, diabetes insipidus, diabetic neuropathy, amyloidosis, and autoimmune neuropathies
    2. Subjects have known intolerance to other NE reuptake inhibitor (NRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
    3. Subjects use concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction
    4. Subjects have used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to randomization or requires concomitant use until the follow-up visit
    5. Subjects have changed dose, frequency, or type of prescribed medication for orthostatic hypotension (e.g., ephedrine, dihydroergotamine, or fludrocortisone), within 7 days prior to randomization visit
    6. Subjects have known or suspected alcohol or substance abuse within the past 12 months
    7. Subjects have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months
    8. Subjects used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to randomization
    9. Subjects with history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject
    10. Subjects with any significant uncontrolled cardiac arrhythmia
    11. Subjects have a Montreal Cognitive Assessment (MoCA) =23
    12. Subjects unable or unwilling to complete all protocol specified procedures including questionnaires
    13. Subjects have myocardial infarction in the past 6 months or has current unstable angina
    14. Subjects have known congestive heart failure
    15. Subjects have any malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma within the past 2 years prior to screening
    16. Subjects have known gastrointestinal (GI) condition which may affect the absorption of study medication
    17. Subjects have psychiatric, neurological, or behavioral disorders that may interfere with the ability of the subject to give informed consent, or interfere with the conduct of the study
    18. Subjects currently receiving any investigational drug or has received an investigational drug within 30 days of dosing
    19. Subjects have clinically significant abnormal laboratory findings
    20. Subjects have demonstrated a history of lifetime suicidal ideation and/or suicidal behavior
    21. Subjects with concurrent disease or condition that would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug

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