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Trial record 2 of 4 for:    TD-9855

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Theravance Biopharma R & D, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier:
NCT02705755
First received: March 7, 2016
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
Neurogenic Orthostatic Hypotension Drug: TD-9855 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma R & D, Inc.:

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

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

Estimated Enrollment: 30
Study Start Date: May 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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         
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Ross Vickery, Ph.D. Theravance Biopharma, US, Inc.
  More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02705755     History of Changes
Other Study ID Numbers: 0145
Study First Received: March 7, 2016
Last Updated: July 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 25, 2017