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Protocol Intervention Group for Huntington's Disease

N/A
Waitlist Available
Led By David Isaacs
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has at least 1 neuropsychiatric symptom, as reported by their HD provider
21 and older will be included, as symptoms of Juvenile HD (in patients 20 years old or less) can present differently
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 18 months
Awards & highlights

Study Summary

This trial will compare the effects of a usual care protocol (medication and counseling intervention) on neuropsychiatric and quality of life outcomes in patients with HD, compared to those who only receive clinical assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have at least one mental or emotional symptom reported by your healthcare provider.
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Only individuals who are 21 years old or older will be included in the study because the symptoms of Juvenile Huntington's disease can be different in patients who are 20 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in quality of life- Ability to Participate in Social Roles and Activities
Change in quality of life- Anxiety
Change in quality of life- Caregiver Strain
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Protocol Intervention GroupExperimental Treatment1 Intervention
These participants will transfer their clinical care to the study provider for the duration of the study, and their symptom treatment will be guided by the study protocol.
Group II: Clinical Standard Care GroupActive Control1 Intervention
These patients will continue to be seen by their regular neurology provider for Huntington's disease. They will not be treated explicitly according to the protocol, though they may be prescribed some of the same medications.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
669,027 Total Patients Enrolled
Teva Pharmaceuticals USAIndustry Sponsor
230 Previous Clinical Trials
188,076 Total Patients Enrolled
David Isaacs4.03 ReviewsPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
2Patient Review
I was extremely disappointed because the physician didn't even bother to do the examination for the reason I had come in. They were not helpful at all.

Media Library

Protocol Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT03417583 — N/A
Huntington's Disease Research Study Groups: Protocol Intervention Group, Clinical Standard Care Group
Huntington's Disease Clinical Trial 2023: Protocol Intervention Group Highlights & Side Effects. Trial Name: NCT03417583 — N/A
Protocol Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03417583 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of participants involved in this research project?

"Correct. According to clinicaltrials.gov, this medical investigation opened on 9th November 2018 and is still open for recruitment as of 8th January 2022. The research team requires 100 individuals from a single site to take part in the trial."

Answered by AI

Is enrollment for this investigation currently accessible to applicants?

"Confirmed, this clinical trial is presently searching for participants. It initially appeared on the 11th of September 2018 and was most recently updated on the 1st of August 2022 according to details provided by clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Vanderbilt Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Mar 2025