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TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)

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ClinicalTrials.gov Identifier: NCT02705755
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.

Brief Summary:
This multiple-center, 3-Cohort, single-blind dose escalation (Cohort 1), randomized, double-blind (Cohort 2), and open-label multiple dose extension (Cohort 3C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance.

Condition or disease Intervention/treatment Phase
Neurogenic Orthostatic Hypotension Multiple System Atrophy (MSA) With Orthostatic Hypotension Pure Autonomic Failure Parkinson Disease Hypotension, Orthostatic Orthostatic Hypotension Drug: TD-9855 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: TD-9855: Cohort 1
Subjects will receive multiple escalating doses of TD-9855 and placebo.
Drug: TD-9855 Drug: Placebo
Experimental: TD-9855: Cohort 2
Subjects will receive single dose of TD-9855 or placebo.
Drug: TD-9855 Drug: Placebo
Experimental: TD-9855: Cohort 3
Subjects will receive daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm.
Drug: TD-9855



Primary Outcome Measures :
  1. Seated systolic blood pressure [ Time Frame: 6 to 8 hours after drug administration ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to approximately 36 days for Cohort 1 ]
  2. Adverse Events [ Time Frame: Up to approximately 57 days for Cohort 2 ]
  3. Adverse Events [ Time Frame: Up to approximately 168 days for Cohort 3 ]
  4. Orthostatic hypotension symptoms [ Time Frame: Up to approximately 168 days for Cohort 3 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, or pure autonomic failure, (i.e. neurogenic orthostatic hypotension).
  • At screening, subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a ≥ 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.
  • Impaired autonomic reflexes, as determined by absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performed, as appropriate.
  • For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Cohort 1.

Exclusion Criteria:

  • Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
  • Concomitant use of vasoconstricting agents for the purpose of increasing BP such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or five half-lives (whichever is longer; and at least 7 days for fludrocortisone for the open label extension) prior to dosing on Day 1 and throughout the duration of the study.
  • Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
  • Known or suspected alcohol or substance abuse within the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705755


Contacts
Contact: Wayne Yates 650-808-6000 WYates@theravance.com

Locations
United States, California
Collaborative Neuroscience Network, LLC. Recruiting
Long Beach, California, United States, 90806
Contact: Shelly Asbill, B.S.    855-425-1515    ShellyAsbill@cnstrial.com   
Principal Investigator: Omid Omidvar, MD         
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Emily Zielinski    248-957-8940    emily@questri.com   
Contact: Colin Sheedy    248-957-8940    colin@questri.com   
Principal Investigator: Aaron Ellenbogen, D.O.         
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Contact: Lisa Wilkins    856-753-7335    lwilkins@hritrials.com   
Principal Investigator: Michael Hassman, M.D.         
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jose Martinez    212-263-7225    Jose.Martinez@nyumc.org   
Principal Investigator: Horacio Kaufmann, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bonnie K. Black, RN, ANP    615-343-6862    Bonnie.Black@Vanderbilt.Edu   
Principal Investigator: Italo Biaggioni, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Steve Hopkins, CCRC    214-648-9275    steve.hopkins@UTSouthwestern.edu   
Principal Investigator: Meredith Bryarly, MD         
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Ross Vickery, Ph.D. Theravance Biopharma, US, Inc.

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02705755     History of Changes
Other Study ID Numbers: 0145
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theravance Biopharma R & D, Inc.:
Neurogenic Orthostatic Hypotension (nOH)
Multiple System Atrophy (MSA)
Pure Autonomic Failure
Parkinson Disease(PD)
nOH
MSA
PD
PAF
Orthostatic Hypotension

Additional relevant MeSH terms:
Parkinson Disease
Atrophy
Hypotension
Hypotension, Orthostatic
Multiple System Atrophy
Shy-Drager Syndrome
Pure Autonomic Failure
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases