A Phase 3 22-week Multi-center Randomized Withdrawal 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:
    Inclusion Criteria (For 0169 Completers Group):
    1. Subjects who have completed 4 weeks of double blind treatment in Study 0169 (V6) and, in the opinion of the Investigator, could benefit from continued treatment with TD-9855
    2. Subjects have a minimum of 80% study medication compliance in Study 0169
    3. Subjects must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures
    4. Subjects must be willing to continue on treatment as per the protocol
    Inclusion Criteria (For De Novo Group):
    1. Subjects are at least 30 years old
    2. Female subjects must be non-pregnant and non-lactating
    3. During the Study and for 1 month after receiving the last dose of the Study drug, females of childbearing potential or males capable of fathering children must agree to use adequate birth control measures
    4. Subjects must meet the diagnostic criteria of snOH as per the protocol
    5. For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria (1992).
    6. 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).
    7. 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.
    8. Subjects who are willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.

You may not be eligible for this study if the following are true:

  • Exclusion Criteria (For 0169 Completers Group):
    1. Subjects may not be enrolled in another clinical trial (other than exiting Study 0169).
    2. Subjects with psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
    3. Subjects with medical, laboratory, or surgical issues deemed by the investigator to be clinically significant.
    4. Subjects with uncooperative attitude or reasonable likelihood of non-compliance with the protocol
    5. Subjects who have a concurrent disease or condition that, in the opinion of the investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug
    Exclusion Criteria (For De Novo Group):
    1. Subjects with known systemic illness known to produce autonomic neuropathy, including, but not limited to, diabetes mellitus, diabetes insipidus, diabetic neuropathy, amyloidosis, or autoimmune neuropathies
    2. Subjects with known intolerance to other NRIs or serotonin norepinephrine reuptake inhibitors (SNRIs).
    3. Subjects currently uses concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction
    4. Subjects with known or suspected alcohol or substance abuse
    5. Subjects who have clinically unstable coronary artery disease
    6. Subjects who have history of untreated closed angle glaucoma, or treated closed angle glaucoma
    7. Subjects with unable or unwilling to complete all protocol specified procedures including questionnaires.
    8. Subjects who had a myocardial infarction in the past 6 months or has current unstable angina.
    9. Subjects with known congestive heart failure or malignant disease or gastrointestinal (GI) condition
    10. Subjects currently receiving any investigational drugs

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