Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

Symptomatic Neurogenic Orthostatic Hypotension Clinical Trial

— OAK  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04095793
• Other study ID #: 0171
• Secondary ID: 2019-002425-30
• Status: Terminated
• Phase: Phase 3
• Start date: September 19, 2019
• Est. completion date: November 12, 2021

Study information

• Verified date: November 2022
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

Description:

This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Pure Autonomic Failure
• Symptomatic Neurogenic Orthostatic Hypotension

Intervention

Drug:
• ampreloxetine
Oral tablet, QD

Locations

Country	Name	City	State
Australia	Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre	Clayton	Victoria
Australia	Concord Hospital, Neurosciences Department	Concord	New South Wales
Australia	Perron Institute for Neurological and Translational Science	Nedlands	Western Australia
Austria	Universitätsklinikum Tulln Abteilung fur Neurologie	Tulln
Bulgaria	MHATNP -Sv. Naum- EAD	Sofia
Bulgaria	MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders	Sofia
Canada	Montreal Neurological Institute & Hospital	Montréal	Quebec
Denmark	Bispebjerg Hospital	Copenhagen
Estonia	Tartu University Hospital	Tartu
France	CHU de Nîmes - Hôpital Caremeau	Nîmes	Gard
Germany	Charite - Campus Virchow- Klinikum, Klinik fur Neurologie	Berlin
Germany	Praxis Dr. med. Christian Oehlwein	Gera	Thueringen
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria	Bologna
Italy	UO Farmacia Centralizzata OM (SC) Ospedale Maggiore	Bologna
Italy	Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento	Roma
Italy	Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia	Roma
Italy	AOU San Giovanni di Dio e Ruggi d'Aragona	Salerno
Italy	Ospedaliera Santa Maria Terni	Terni	Umbria
New Zealand	New Zealand Brain Research Institute	Christchurch
Poland	Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala	Katowice
Poland	Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej	Kraków
Poland	Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.	Oswiecim
Poland	Neuro-Care Sp. z o.o. sp. Komandytowa	Siemianowice Slaskie
Poland	ETG Warszawa	Warszawa
Poland	Specjalistyczn.e Gabinety Sp. Z o.o.	Warszawa
Portugal	Campus Neurologico Senior	Torres Vedras
Russian Federation	Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency	Krasnoyarsk
Russian Federation	Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency	Krasnoyarsk
Russian Federation	SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF	Moscow
Russian Federation	Limited Liability Company City Neurological Center Sibneiromed	Novosibirsk
Russian Federation	State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34	Novosibirsk
Russian Federation	FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation	Saint Petersburg
Spain	Hospital del Mar	Barcelona
Spain	Hospital de Cruces	Bilbao
Spain	Hospital Universitario de La Princesa	Madrid
Ukraine	Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine	Kharkiv
Ukraine	Lviv Regional Clinical Hospital	Lviv
Ukraine	CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology	Vinnytsia
United Kingdom	Re:Cognition Health Ltd	London
United Kingdom	The National Hospital for Neurology & Neurosurgery	London	Greater London
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati Medical Center (UCGNI)	Cincinnati	Ohio
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University School of Medicine	New York	New York
United States	Neurostudies, Inc.	Port Charlotte	Florida
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Inland Northwest Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  Denmark,  Estonia,  France,  Germany,  Israel,  Italy,  New Zealand,  Poland,  Portugal,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.; Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.	Day 1 up to a maximum of 749 days