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Proven Successes

Accelerating Treatments That Make a Difference

Join us in celebrating our achievements and witnessing the innovative and transformative impact of HSG’s three decades of dedication to accelerating treatments to those affected by Huntington’s disease.

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We have conducted the most clinical trials in Huntington's disease in the world.

Clinical Trials That Resulted in the Only Three FDA-Approved Drugs for Huntington’s disease

tetrabenazine

2008
Tetrabenazine (Xenazine®)

deutetrabenazine2

2017
Deutetrabenazine (Austedo®)

valbenazine

2023
Valbenazine (Ingrezza®)

Discover our Triumphs

Clinical Trial Excellence

Since its inception in 1993, the HSG has been at the forefront of advancing knowledge and treatment options for HD. The HSG has conducted more than 40 clinical trials and studies, making significant strides in the field of HD research and consistently demonstrating excellence in clinical research. Our rigorous and innovative methodologies, streamlined processes, and dedicated and longstanding teams have contributed to the achievements that form the bedrock of conducting successful clinical trials and studies in HD. HSG Clinical Research, Inc. (HSGCR), HSG’s clinical research organization (CRO), provides world class clinical trial operations to facilitate the advancement of meaningful therapies for HD.  HSG reinvests the net revenue generated from HSGCR into our mission-driven initiatives.

Unified Huntington’s Disease Rating Scale (UHDRS®)

The UHDRS® was developed by the HSG to help categorize and quantify HD disease symptoms and severity and to help assess disease progression over time. The UHDRS® is recognized by the FDA as a primary endpoint for clinical trials. Instructions for use and access to this tool for clinical trials can be found here. License fees may apply.

FDA-Approved Breakthroughs

The HSG’s unwavering efforts have resulted in groundbreaking achievements. HSG conducted trials have led to the approval of the first three, and to date, only FDA-approved drugs for the treatment of chorea in HD, including tetrabenazine, deutetrabenezine, and valbenazine. These accomplishments demonstrate significant progress in providing symptomatic relief for individuals affected by HD. We are uniquely positioned to continue advancing innovative research aimed at improving lives and shaping the future of HD treatment.

HSG Network

Our broad network of collaborators and sponsors range from leading biotech and pharmaceutical companies to foundations, CROs, academic institutions, and advocacy partners, all united within the HD community. As a pioneer in the conduct of HD clinical trials and studies, the HSG stands out for its unwavering commitment to excellence. With over 130 HSG credentialed and trial-ready research sites, a formidable team of more than 400 HSG-trained site investigators and coordinators, and a vast international network of researchers, we are a catalyst to accelerating treatments that make a difference for HD.

40+ Total Clinical Trials in HD

Observational Studies
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Phase I/II Trials
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Phase II/III Trials
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Study Details Global FDA

PROOF-HD DB & OLE
Prilenia Therapeutics

Ph 3
499 Participants

KINECT-HD-2
Neurocrine Biosciences

OLE
154 Participants

vUHDRS
HSG

Observational
60 Participants

myHDstory
HSG

Observational
685 Participants

SIGNAL
Vaccinex

Ph 2
301 Participants

LEGATO-HD
Teva

Ph 2
~400 Participants

ARC-HD
Auspex

Ph 3
119 Participants

First-HD
Auspex

Ph 3
90 Participants

Pride-HD
Teva

Ph 2
~400 Participants

PREDICT-HD
CHDI

Observational
900 Participants

Reach2HD
Prana

Ph 2
100 Participants

PHAROS
NIH, High Q Foundation, CHDI

Observational
1001 Participants

HORIZON Plus
Medivation (with Pfizer)

Ph 3
350 Participants

Open-HART
NeuroSearch Sweden

Ph 2
~220 Participants

HORIZON
Medivation (with Pfizer)

Ph 3
403 Participants

PREQUEL
NIH

Ph 2
90 Participants

HART
NeuroSearch Sweden

Ph 2/3
220 Participants

CREST-E
NIH

Ph 3
650 Participants

COHORT
High Q Foundation, CHDI

Observational
2200 Participants

DIMOND B
Medivation

Ph 2
90 Participants

DIMOND A
Medivation

Ph 1/2
9 Participants

DOMINO
FDA

Ph 2/3
125 Participants

PHEND-HD
NIH, HP Therap. Found

Ph 2
60 Participants

TREND-HD
Amarin Neurosciences

Ph 3
316 Participants

2CARE
NIH

Ph 3
608 Participants

RESPOND
NIH

Observational
400 Participants

TETRA Withdrawal
Prestwick

Ph 3
30 Participants

TETRA-HD
Prestwick

Ph 3
84 Participants

TETRA Long Term
Prestwick

Ph 3
54 Participants

QuBE
CHDI

 Ph 1
24 Participants

Pre-2CARE
CHDI

Ph 2

30 Participants

 

MINO
FDA, HDSA, HDF

Ph 2
63 Participants

Creatine
HDSA

Ph 2
50 Participants

RID-HD
FDA

Ph 2
63 Participants

CARE-HD
NIH

Ph 2
347 Participants

UHDRS
HSG

Observational
7000 Participants

INTRO-HD
Otsuka America Pharma.

Ph 2
64 Participants

START-HD
Fisons Pharma.

Ph 1
31 Participants

Note: Many HSG studies were conducted with vendor partners including the Center for Health + Technology (CHeT), University of Rochester School of Medicine and Dentistry Clinical Trials Coordination Center.

Innovation

The HSG has led the way with novel approaches to maximizing recruitment, enrollment and retention of study participants and optimizing study results.

First in HD to Use Wearable Sensors

First IV Infusion Study in HD

First HD Adaptive Design Trial

First Unique Platform Developed for HD Direct-to-Participant Recruitment

First HD Study that “Reached the Unreachable” for Enrollment and Trial Followup

First Conduct of Virtual Clinical Assessments

First Implementation of Remote HD Clinical Trials

Our Network

At the core of our success are the places, people, and participants that help us serve our mission.

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HSG Members

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Credentialed Trial Sites Worldwide

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HD Participants Enrolled in HSG Studies

By selecting HSGCR for your next clinical study, partners can leverage our innovation and infrastructure to ensure they have the highest impact on clinical trial success. We look forward to working with you.

3 Decades of Unmatched Global HD Research History

Note: Many HSG studies were conducted with vendor partners including the Center for Health + Technology (CHeT), University of Rochester School of Medicine and Dentistry Clinical Trials Coordination Center.

Discovery and Growth

1993-2011 – HSG developed the standards and conducted the first 30+ HD clinical trials and observational studies

Highlights

1993: the HD gene was identified.  Inspired by this finding and the need to build a network of HD experts dedicated to seeking treatments that make a difference for HD, Dr. Ira Shoulson and Dr. Jack Penney formed the Huntington Study Group headquartered at the University of Rochester.  

An initial network of HSG research sites was developed and HD trial standards were created. 

The first conceptual annual HSG meeting was held in Bethesda, MD. 

HSG conducts first of many industry-sponsored interventional clinical trials in Huntington's disease.

1994: HSG develops and validates the UHDRS®, considered the primary clinical endpoint in HD trials and studies.

1996: UHDRS® publication in Movement Disorders

1993-1997

HSG initiates observational studies, PHAROS, PREDICT, COHORT, Project AWARE; several studies were NIH/FDA/CHDI Foundation sponsored. Enrolled over 10,000 HD participants, results of which continue to inform the designs of clinical trials and the natural history of HD. 

2008: HSG trial, TETRA-HD, results in FDA approved first treatment of chorea in HD, tetrabenazine, sponsored by Prestwick.

2009 - 2012: HSG conducts, HORIZON, the first global clinical trial in HD.

2010 - 2011: Project AWARE, largest US remote survey study of 600 participants, assesses HD family members’ Awareness, Willingness, and Ability in Research and Education.

1998-2012

Independence, Innovation, and Expansion

2012 – present –  HSG continues to build on a strong foundation as an independent organization

HSG forms independent, not-for-profit, 501(C) organization and moves to new headquarters 

HSG launches CME4HD™, an accredited learning program for healthcare professionals and care providers.

2012 - 2013

Reach2HD trial published in Lancet Neurology, premier scientific journal for neurological research 

2014

SIGNAL trial launches, PH II, Adaptive Design, sponsored by Vaccinex, Inc. and the first infusion study in HD

HSG publishes first issue of HD Insights magazine , a periodical highlighting HD research

Multi-center, multi-national trials in HD continue to expand

2015

HSG celebrates 25 years and launches on-line version of CME4HD.

2018

KINECT-HD, a PH III pivotal trial launches, including use of the first wearable sensors in HD. Trial sponsored by Neurocrine Biosciences.

2019

HSG forms wholly owned CRO, HSG Clinical Research, Inc.,

PROOF-HD Trial, PH III global trial initiated, enrolling 499 participants, across 30 US sites, and 29 European sites.

HSG holds first virtual annual meeting, persevering through pandemic concerns.

2020

HSG creates myHDstory®, a direct-to-participant online platform to conduct the first online observational HD study.  “Reaching the Unreachable,” the platform successfully makes HD research more widely accessible.

2021

HSG launches first observational virtual study, vUHDRS®, assessing reliability of administering the UHDRS remotely.

2022

HSG trial, KINECT-HD, results in  the third FDA approved medication for the treatment of chorea in HD,  valbenazine (Ingrezza), sponsored by Neurocrine Biosciences.

HSG completes myHDstory® pilot study, enrolling 600 participants with greater diversity in racial and ethnic participation than ever seen in an HD study.

PROOF-HD Trial announces completion, global (North America and Europe), ahead of schedule enrollment of 499 participants during COVID, sponsored by Prilenia Therapeutics.

HSG Forms a new Education Center – the HSG Brainery, consolidating established programs with new and innovative programs, platforms, and technology.

2023

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Leave it to the experts at HSGCR to deliver the counsel, collaboration and clinical support you need to help you and your team improve the quality and outcomes of your clinical study.

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