Huntington DiseaseNCT00313495
Cooperative Huntington's Observational Research Trial
An observational study of Huntington Disease, run by HP Therapeutics Foundation at 52 sites in 3 countries.
Trial summary
The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- How many people
- 5,000 participants
- Where
- 52 sitesin 3 countries
- Study dates
- Feb 2006to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. An individual of any age that is affected by Huntington's disease 2. An individual 18 years of age or older, who has tested positive for the HD gene 3. An individual 18 years of age or older who is a parent, sibling or child of an individual affected by HD 4. An older adolescent 15 to 17 years of age, who has a parent affected by HD enrolled in COHORT, or a parent who has tested positive for the HD gene enrolled in COHORT (at select sites) 5. Grandparents and grandchildren of anyone participating in COHORT who fulfills the requirements of (the above) category (1) or (2) 6. HD family members who have no risk for HD due to no family history (spouses or caregivers) 7. HD family members who have undergone DNA testing and does not carry the genetic mutation responsible for HD.
Who may be able to join
- (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.
- (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.
- (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
- (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
- (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.
Who cannot join
- (1) Anyone who does not fit the inclusion criteria
Trial locations and contacts
52 sites in 3 countries.
Huntington Study Group contact
52 sites in 3 countries
United States41 sites, 39 recruiting
- Recruiting
Albany Medical College
Albany, New York
Sharon Evans, 518-262-6611, evanss@mail.amc.edu
- Recruiting
Emory University
Atlanta, Georgia
Elaine Sperin, 404-728-4786, esperin@emory.edu
- Recruiting
Medical College of Georgia
Augusta, Georgia
Buff Farrow, 706-721-0619, bfarrow@georgiahealth.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland
Claire Welsh, 410-955-1349, cswelsh@jhmi.edu
- Recruiting
University of Maryland
Baltimore, Maryland
Lauren Doyle, 410-328-3339, ldoyle@upi.umaryland.edu
- Terminated
University of Alabama at Birmingham
Birmingham, Alabama
- Recruiting
Boston University School of Medicine
Boston, Massachusetts
Melissa Diggin, 617-638-7704, melissa.diggin@bmc.org
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts
Robert McInnis, 617-723-5694, rmcinnis@partners.org
- Recruiting
University of Virginia
Charlottesville, Virginia
Robert Davis, 434-243-5692, rbd4n@virginia.edu
- Recruiting
Rush University Medical Center
Chicago, Illinois
Jeana Jaglin, 312-942-5003, jjaglin2@rush.edu
- Recruiting
University of Chicago
Chicago, Illinois
Joan Young, 773-702-4392, jyoung@neurology.bsd.uchicago.edu
- Recruiting
University of Cincinnati
Cincinnati, Ohio
Mary Beth Bialick, 513-558-0018, howardb33@aol.com
- Recruiting
The Cleveland Clinic
Cleveland, Ohio
Christine Reece, 216-445-9833, houser@ccf.org
- Recruiting
Ohio State University
Columbus, Ohio
Allison Seward, 614-688-8672, allison.seward@osumc.edu
- Recruiting
Southwestern Medical Center
Dallas, Texas, 75390
Giselle Huet, MS, 214-648-0378, giselle.huet@utsouthwestern.edu
Amit Gode, MPH, 214-648-0417, amit.gode@utsouthwestern.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina
Sarah Wyne, 919-668-2837, wyne1991@duke.edu
- Recruiting
University of Connecticut
Hartford, Connecticut
Mary Jane Fitzpatrick, 860-679-4441, fitzpatrick@psychiatry.uchc.edu
- Recruiting
Baylor College of Medicine
Houston, Texas
Tiffany Reedus, 713-798-7438, treedus@bcm.edu
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana
Melissa Wesson, 317-274-2390, mkwesson@iupi.edu
- Recruiting
University of Iowa
Iowa City, Iowa
Michelle Harreld, 319-384-1174, michelle-harreld@uiowa.edu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas
Hillary Dubinsky, 913-945-5019, hdubinsky@kumc.edu
- Recruiting
Booth Gardner Parkinsons Center
Kirkland, Washington, 98034
Marsha Merrick, 425-899-3115, mgmerrick@evergreenhealthcare.org
- Recruiting
Colorado Neurological Institute
Littleton, Colorado
Diane Erickson, 303-762-6674, derickson@thecni.org
- Recruiting
UCLA School of Medicine
Los Angeles, California
Angeline Gratiano, 310-206-2154, agratiano@mednet.ucla.edu
- Recruiting
University of Louisville
Louisville, Kentucky, 40294
Annette Robinson, 502-540-3585, annette.robinson@louisville.edu
- Recruiting
University of Tennessee-Memphis
Memphis, Tennessee
Nathan Jones, 901-448-6180, njones37@utmem.edu
- Recruiting
University of Miami School of Medicine
Miami, Florida
Monica Quesada, 305-243-3647, mquesada2@med.miami.edu
- Active, not recruiting
Hennepin County Medical Center
Minneapolis, Minnesota
- Recruiting
Institutue for Neurodegenerative Disorders
New Haven, Connecticut
Candace Cotto, 203-401-4339, ccotto@indd.org
- Recruiting
Columbia University
New York, New York
Ronda Clouse, 212-305-2387, clouser@sergievsky.cpmc.columbia.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania
Iman Affan, 215-829-3582, iman.affan@uphs.upenn.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania
Nancy Lucarelli, 412-692-4659, lucarellina2@upmc.edu
- Recruiting
University of Rochester
Rochester, New York
Amy Chesire, 585-341-7519, amy.chesire@ctcc.rochester.edu
- Recruiting
University of California, Davis
Sacramento, California
Nicole Mans, 916-734-3541, nicole.mans@ucdmc.ucdavis.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Paola Wall, 801-581-4543, paola.wall@hsc.utah.edu
- Recruiting
University of California, San Diego
San Diego, California
jody goldstein, 858-622-5854, jlgoldstein@ucsd.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Jonathan Gooblar, BA, 415-476-1686, jgooblar@memory.ucsf.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri
Stacey Barton, 314-362-3471, bartons@neuro.wustl.edu
- Recruiting
University of South Florida
Tampa, Florida
Marcia McCall, 813-974-6022, mamccall@hsc.usf.edu
- Recruiting
Hereditary Neurological Disease Center
Wichita, Kansas
Greg Suter, 316-721-9250, hndcentre@aol.com
- Recruiting
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina
Christine O'Neill, 336-716-8611, coneil@iupui.edu
Canada8 sites, 8 recruiting
- Recruiting
University of Calgary Medical Clinic
Calgary, Alberta
Mary Lou Klimek, 403-210-8548, klimek@ucalgary.ca
- Recruiting
Halifax Infirmary
Halifax, Nova Scotia, B3H1V7
Joanne Courtney-Walker, 902-473-8261, joanne.walker@cdha.nshealth.ca
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Emilija Makaji, MSC, 519-685-8500 ext. 36893, emilija.makaji@lhsc.on.ca
- Recruiting
The Centre for Addiction and Mental Health
Markham, Ontario
Irita Karmalkar, 905-472-7082 ext. 229, ikarmalkar@movementdisorders.ca
- Recruiting
Hotel-Dieu Hospital-CHUM
Montreal, Quebec
Suzanne Paris, 514-890-8000 ext. 26511, suzanne.paris.chum@ssss.gouv.qc.ca
- Recruiting
University of British Columbia
Vancouver, British Columbia
Allison Coleman, 604-822-7739, allison@cmmt.ubc.ca
- Recruiting
Movement Disorder Clinic Deer Lodge Centre
Winnipeg, Manitoba
Sandra Funk, 204-940-8547, sfunk@mdc-dlc.ca
- Recruiting
Movement Disorders Clinic, Deer Lodge Centre
Winnipeg, Manitoba
Sandra Funk, 204-940-8547, sfunk@mdc-dlc.ca
Australia3 sites, 3 recruiting
- Recruiting
The University of Melbourne
Kew, Victoria
Bernadette Mannaa, 61 3 9816 0444 ext. 8114, bmannaa@unimelb.edu.au
- Recruiting
Graylands, Selby-Lemnos & Special Care Health Services
Perth, Western Australia, 6910
Steve Andrew, 618 9347 6464, steve.andrews@health.wa.gov.au
- Recruiting
Westmead Hospital
Wentworthville, New South Wales
Jane Griffith, 011-61-2-98456793, jane_griffith@wsahs.nsw.gov.au
About this study
The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.
Read the detailed description
COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials.
- Conditions
- Huntington Disease
- Keywords
- Huntington disease, observational, family members, biomarker
- Medical subject headings
- Huntington Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HP Therapeutics Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Huntington Study Group
- Investigators
- Ira Shoulson, MD, Principal investigator, University of Rochester/Huntington Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313495
- Sponsor's protocol ID
- COHORT
- Status last verified
- Mar 2011
- First submitted
- 10 Apr 2006
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Connors MH, Teixeira-Pinto A, Loy CT. Psychosis and longitudinal outcomes in Huntington disease: the COHORT Study. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):15-20. doi: 10.1136/jnnp-2019-320646. Epub 2019 Oct 13.
PubMed 31611263Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.
PubMed 24126537Huntington Study Group COHORT Investigators; Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16.
PubMed 22359536
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Huntington's Observational Research Trial
- ClinicalTrials.gov ID
- NCT00313495
- Acronym / sponsor ID
- COHORT
- Conditions
- Huntington Disease
- Keywords
- Huntington disease, observational, family members, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- HP Therapeutics FoundationUniversity, hospital or other
- Collaborators
- Huntington Study Group
- Study start
- Feb 2006
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.
Detailed description
COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. An individual of any age that is affected by Huntington's disease 2. An individual 18 years of age or older, who has tested positive for the HD gene 3. An individual 18 years of age or older who is a parent, sibling or child of an individual affected by HD 4. An older adolescent 15 to 17 years of age, who has a parent affected by HD enrolled in COHORT, or a parent who has tested positive for the HD gene enrolled in COHORT (at select sites) 5. Grandparents and grandchildren of anyone participating in COHORT who fulfills the requirements of (the above) category (1) or (2) 6. HD family members who have no risk for HD due to no family history (spouses or caregivers) 7. HD family members who have undergone DNA testing and does not carry the genetic mutation responsible for HD.
Key inclusion criteria (5 listed)
- (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.
- (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.
- (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
- (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
- (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.
Key exclusion criteria (1 listed)
- (1) Anyone who does not fit the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
- Derived from this study: PubMed 31611263Connors MH, Teixeira-Pinto A, Loy CT. Psychosis and longitudinal outcomes in Huntington disease: the COHORT Study. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):15-20. doi: 10.1136/jnnp-2019-320646. Epub 2019 Oct 13.
- Derived from this study: PubMed 24126537Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.
- Derived from this study: PubMed 22359536Huntington Study Group COHORT Investigators; Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16.
- The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huntington Study Group contact
Ira Shoulson, MD principal investigator
University of Rochester/Huntington Study Group
52 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by HP Therapeutics Foundation at 52 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huntington Study Group (800-487-7671), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313495, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.