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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705755
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
Seated systolic blood pressure [ Time Frame: 6 to 8 hours after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Adverse Events [ Time Frame: Up to approximately 36 days for Part A ]
  • Adverse Events [ Time Frame: Up to approximately 57 days for Part B ]
  • Adverse Events [ Time Frame: Up to approximately 168 days for Part C ]
  • Orthostatic hypotension symptoms [ Time Frame: Up to approximately 168 days for Part C ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
Adverse Events [ Time Frame: 57 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
Official Title  ICMJE A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension
Brief Summary This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurogenic Orthostatic Hypotension
  • Multiple System Atrophy (MSA) With Orthostatic Hypotension
  • Pure Autonomic Failure
  • Parkinson Disease
  • Hypotension, Orthostatic
  • Orthostatic Hypotension
  • Pure Autonomic Failure With Orthostatic Hypotension
  • Parkinson Disease With Orthostatic Hypotension
Intervention  ICMJE
  • Drug: TD-9855
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: TD-9855 Part A
    Subjects will receive placebo and escalating single doses of TD-9855
    Interventions:
    • Drug: TD-9855
    • Drug: Placebo
  • Experimental: TD-9855 Part B
    Subjects will receive a single dose of TD-9855 or placebo.
    Intervention: Drug: TD-9855
  • Experimental: TD-9855 Part C
    Subjects will receive once daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm.
    Intervention: Drug: TD-9855
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2016)
30
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Part A.

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 be stopped at least 2 days or five half lives (whichever is longer) prior to dosing on Day 1 of Part A and C, and throughout the duration of Part C. Subjects previously enrolled in Part A under previous versions of the protocol will continue taking fludrocortisone during the washout period and in Part C at the dose and regimen used in Part A. For new subjects enrolling in Part A under Amendment 3, fludrocortisone use in both Parts of the study and during the washout period will be limited to 0.1 mg QD.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02705755
Other Study ID Numbers  ICMJE 0145
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma, US, Inc.
PRS Account Theravance Biopharma
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP