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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT02705755
• Date of registration: 07/03/2016
• Prospective Registration: Yes
• Primary sponsor: Theravance Biopharma
• Public title: TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
• Scientific title: A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension
• Date of first enrolment: May 2016
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02705755
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Medical Monitor
• Affiliation: Theravance Biopharma, US, Inc.

Key inclusion & exclusion 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 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy (MSA) With Orthostatic Hypotension

Hypotension, Orthostatic

Neurogenic Orthostatic Hypotension

Parkinson Disease

Pure Autonomic Failure With Orthostatic Hypotension

Parkinson Disease With Orthostatic Hypotension

Pure Autonomic Failure

Orthostatic Hypotension

Intervention(s)

Drug: Placebo

Drug: TD-9855

Primary Outcome(s)

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

Secondary Outcome(s)

Adverse Events [Time Frame: Up to approximately 57 days for Part B]

Adverse Events [Time Frame: Up to approximately 168 days for Part C]

Adverse Events [Time Frame: Up to approximately 36 days for Part A]

Orthostatic hypotension symptoms [Time Frame: Up to approximately 168 days for Part C]

Secondary ID(s)

0145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors