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Study Summary
This trial will study whether SAGE-718 can improve cognition in people with Huntington's disease.
- Huntington's Disease
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 18 Patients • NCT04476017Trial Design
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Who is running the clinical trial?
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- You have a confirmed genetic disease with a huntingtin gene expansion of 36 or more repeats.You have taken part in a study involving SAGE-718 or any other drug, biologic, or medical device within the past 30 days or 5 half-lives (whichever is longer), unless you only received a placebo. Also, if you have been treated with antisense oligonucleotides (ASOs) or an mRNA splicing modifier, you cannot participate.You have a neurodegenerative condition like Alzheimer's Disease or Parkinson's Disease that is still getting worse.Your UHDRS-Total Functional Capacity (TFC) score is higher than 6 and lower than 13.You do not have any signs of juvenile Huntington's disease.You scored less than 26 on a test called the Montreal Cognitive Assessment (MoCA) during screening.
- Group 1: Placebo
- Group 2: SAGE-718
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there multiple locales partaking in this experiment across the state?
"Currently, 23 different medical centers are participating in the trial. These sites span from Philadelphia to Iowa City and Chicago, as well as other locales. Therefore, it is beneficial for prospective participants to choose an enrolment site that is nearest them so they can reduce their travel burden."
Are there any opportunities for volunteers to participate in this research endeavor?
"Yes, current records on clinicaltrials.gov confirm that this medical trial is actively recruiting participants since its inaugural posting on February 10th 2022 and most recently amended on November 11th 2022. The study requires 178 patients across 23 sites to complete the research."
What is the enrollment rate of people participating in this research?
"Affirmative. Clinicaltrials.gov has information suggesting that this clinical experiment is currently searching for eligible patients, which was first posted on February 10th 2022 and last updated November 11th 2022. 178 participants are needed between 23 centres."
Has SAGE-718 obtained authorization from the FDA?
"Our team believes SAGE-718 to be relatively safe, garnering a score of 2. While there is evidence that the drug may be secure, no research yet indicates its efficacy."
Am I eligible to partake in this medical investigation?
"To be eligible for this trial, applicants must have Huntington's Disease and fall within the age range of 25 to 65. Presently, 178 participants are required."
Does the age of 35 represent a cutoff for possible participation in this research endeavor?
"This medical trial has an age range requirement of 25 to 65 years old for participation. Moreover, there are two separate studies available for those under 18 and 32 additional avenues available for elderly patients over the age of 65."
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