Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Recruiting
Phase 2Phase 3Interventional Study
Huntington Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
25 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Skyhawk Therapeutics, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 25 years or older.
* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).
* Total Functional Capacity (TFC) score of 10 or more).
* Total Motor Score (TMS) of 6 or more).
* Independence Score (IS) …
Inclusion Criteria:
* 25 years or older.
* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).
* Total Functional Capacity (TFC) score of 10 or more).
* Total Motor Score (TMS) of 6 or more).
* Independence Score (IS) of 70 or more).
* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.
* Men must agree to use birth control during the study and for 90 days after the last dose.
* Agree to sign a consent form and follow the study's rules and schedule.
Exclusion Criteria:
* Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.
* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.
* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.
* Severe allergies or have reacted badly to similar drugs in the past.
* Taking medications or treatments that might interfere with the study.
* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).
* Any kind of gene therapy.
* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.
* Liver function tests show significant abnormalities.
* Positive for hepatitis B, hepatitis C, or HIV.
* Pregnancy, breastfeeding, or planning to become pregnant during the study.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.