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Authors
Frank, Samuel https://orcid.org/0000-0002-1866-162X
Testa, Claudia
Edmondson, Mary C.
Goldstein, Jody
Kayson, Elise
Leavitt, Blair R.
Oakes, David
O’Neill, Christine
Vaughan, Christina
Whaley, Jacquelyn
Gross, Nicholas
Gordon, Mark Forrest https://orcid.org/0000-0002-0271-3050
Savola, Juha-Matti https://orcid.org/0000-0001-6208-0841
,
Frank, Samuel https://orcid.org/0000-0002-1866-162X
Testa, Claudia
Stamler, David
Kayson, Elise
Edmondson, Mary C.
Leavitt, Blair R.
Oakes, David
O’Neill, Christine
Vaughan, Christina
Goldstein, Jody
Bockus, Margaret
Leyva, Stephanie
Snively, Victoria
Whaley, Jacquelyn
Wong, Cynthia
Mallonee, William M.
Suter, Gregory
Jankovic, Joseph
Jimenez-Shahed, Joohi
Hunter, Christine
Claassen, Daniel O.
West, Lauren
Roman, Olivia
Sung, Victor
Smith, Jenna
Clouse, Ronda
Saint-Hilaire, Marie
Turpin, Denyse
James, Raymond
Rodriguez, Ramon
Rizer, Kyle
Anderson, Karen
Heller, Hope
Ahmad, Alexis
Criswell, Susan
Racette, Brad A.
Nucifora Jr, Frederick C.
Churchill, Gregory
Ong, MaryJane
Mendis, Tilak
Mendis, Neila
Singer, Carlos
Paulsen, Jane S.
Kerr, Jane
Dubinsky, Richard
Gray, Carolyn
Factor, Stewart A.
Sperin, Elaine
Molho, Eric
Evans, Sharon
Nickels, Breanna
Bergen, Courtney
Jaynes, Jessica
Reeves, Christina
Segro, Vicki
Samii, Ali
Christopher, Emily
Del Castillo, Debra
Chouinard, Sylvain
Perry-Trice, Peggy
Esmail, Sherali
Fung, Wai Lun Alan
Gibbons, Clare
Colcher, Amy
Hackmyer, Cory
McGarry, Andrew
Klos, Kevin
Gudesblatt, Mark
Schneider, Daniel
Dhall, Rohit
Simpson, Edith
Wojcieszek, Joanne
Hurt, Andrea
LaFaver, Kathrin
Robinson, Annette
Revilla, Fredy J.
Duker, Andrew P.
Neefus, Erin
Wilson-Perez, Hilary
Shprecher, David
Hohnholt, Tyler
Wall, Paola
Boyd, James
Houston, Emily
Farbman, Eric S.
Poynor, Shamine
Agarwal, Pinky
Leon, Julissa
Eberly, Shirley
Watts, Arthur
Tariot, Pierre
Feigin, Andrew
Evans, Scott R.
Beck, Christopher A.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct01897896 at ClinicalTrials.govDocuments that mention this clinical trial
The Safety of Deutetrabenazine for Chorea in Huntington Disease: An Open-Label Extension Study
https://doi.org/10.1007/s40263-022-00956-8
Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease
https://doi.org/10.1007/s40120-024-00600-1
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Funding
Funding for this research was provided by:
Teva Pharmaceutical Industries, Tel Aviv, Israel
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More Information
Article History
Accepted: 7 September 2022
First Online: 15 October 2022
Declarations
:
: This study and its open access publication was funded by Teva Pharmaceutical Instrustries, Tel Aviv, Israel.
: Samuel Frank and Claudia Testa served as co-principal investigators of First-HD. Claudia Testa also served as a consultant for Lundbeck, with honoraria donated to the Medical College of Virginia Foundation. Mary C. Edmondson reports serving on a Wave Life Sciences Clinical Advisory Committee, funding from uniQure, and ENROLL-HD DSMB involvement. Blair R. Leavitt is currently employed as a Professor in the Department of Medical Genetics, and Division of Neurology, Department of Medicine and as a senior scientist at the Centre for Molecular Medicine and Therapeutics, The University of British Columbia, and BC Children’s Hospital. In the last 5 years, he has held or applied for research grants in the area of neurodegenerative disease from the Canadian Institutes of Health Research, The Huntington Society of Canada, Weston Brain Foundation, Brain Canada, uniQure, Triplet, and the Nanomedicines Innovations Network. He has served on scientific advisory boards for sRNAlytics, the Huntington’s Disease Society of America, and the Huntington Society of Canada. In addition, he has acted as a paid consultant to Roche, uniQure, Novartis, PTC Therapeutics, Triplet Therapeutics, Genentech, Takeda, and Ionis. He is also a shareholder, co-founder, and CEO of Incisive Genetics Inc., a biotech start-up company developing therapies for genetic brain diseases. David Oakes received research support from Auspex (for the First-HD and related studies), Vaccinex Inc., Prana Pharmaceuticals, Biogen, Inc., and the National Institutes of Health; and received honoraria from Raptor Pharmaceuticals and Voyager Inc. Christina Vaughan received an emergency fast-track COVID-19 response grant from the Adira Foundation. Nicholas Gross and Mark Forrest Gordon are employees of Teva Pharmaceuticals, and Juha-Matti Savola is a former employee of Teva Pharmaceuticals. Jody Goldstein, Elise Kayson, Christine O’Neill, and Jacquelyn Whaley report no disclosures.
: This study (ClinicalTrials.gov identifier: NCT01897896) was approved by the ethics boards at all involved centers prior to subject enrollment and conducted in accordance with the Helsinki Declaration and the International Council for Harmonisation Good Clinical Practice Guidelines.
: At enrollment, an independent qualified healthcare provider assessed all subjects for capacity to provide informed consent, and study personnel subsequently assessed subjects for capacity to continue in the study. Subjects or legally authorized representatives provided written informed consent, and subjects without capacity provided assent, if required by local regulations.
: Not applicable.
: Qualified researchers may request access to patient-level data and related study documents, including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient-level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please e-mail USMedInfo@tevapharm.com to make your request.
: Not applicable.
: SF and MFG contributed to the drafting/revision of the manuscript for content, including medical writing for content, and had a major role in the acquisition of data, study concept or design, and the analysis or interpretation of data. CT, JG, EK, CV, and JW contributed to the drafting/revision of the manuscript for content, including medical writing for content, and had a major role in the acquisition of data and the analysis or interpretation of data. MCE, BRL, CO, and J-MS had a major role in the acquisition of data. DO and NG contributed to the drafting/revision of the manuscript for content, including medical writing for content, and the analysis or interpretation of data. All authors read and approved the final manuscript.
