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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04095793




Registration number
NCT04095793
Ethics application status
Date submitted
1/08/2019
Date registered
19/09/2019

Titles & IDs
Public title
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Scientific title
A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure
Secondary ID [1] 0 0
2019-002425-30
Secondary ID [2] 0 0
0171
Universal Trial Number (UTN)
Trial acronym
OAK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Neurogenic Orthostatic Hypotension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ampreloxetine

Experimental: ampreloxetine - Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.


Treatment: Drugs: ampreloxetine
Oral tablet, QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 up to a maximum of 749 days

Eligibility
Key inclusion criteria
* Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
* The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
* The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects may not be enrolled in another clinical trial.
* 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.
* Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
* Hypersensitivity to ampreloxetine or the formulation excipients.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2021
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital, Neurosciences Department - Concord
Recruitment hospital [2] 0 0
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 0 0
02139 - Concord
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
06009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Austria
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Tulln
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Bulgaria
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Sofia
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Canada
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Quebec
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Denmark
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Copenhagen
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Estonia
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Tartu
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France
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Gard
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Germany
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Thueringen
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Germany
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Berlin
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Israel
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Tel Aviv
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Italy
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Umbria
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Italy
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Bologna
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Italy
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Milano
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Italy
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Roma
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Italy
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Salerno
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New Zealand
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Christchurch
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Poland
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Katowice
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Poland
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Kraków
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Poland
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Oswiecim
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Poland
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Siemianowice Slaskie
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Poland
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Warszawa
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Portugal
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Torres Vedras
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Madrid
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Ukraine
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Kharkiv
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Ukraine
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Lviv
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Ukraine
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Vinnytsia
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United Kingdom
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Greater London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Theravance Biopharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Theravance Biopharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04095793