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Tests treatment safety and results for Huntington Disease
Official title Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
ClinicalTrials.gov ID: NCT07378644
What this study is testing
What is SKY-0515?
SKY-0515 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for huntington disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- 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).
You likely can't join if
- 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).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Buenos Aires, Argentina
- CABA, Buenos Aires, Argentina
- Mendoza, Mendoza Province, Argentina
- Belo Horizonte, Minas Gerais, Brazil
- Campina Grande do Sul, Paraná, Brazil
- Curitiba, Paraná, Brazil
- Rio de Janeiro, Rio de Janiero, Brazil
- Natal, Rio Grande do Norte, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Toronto, Ontario, Canada
- Santiago, Santiago Metropolitan, Chile
- Tbilisi, Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Buenos Aires, Argentina; CABA, Buenos Aires, Argentina; Mendoza, Mendoza Province, Argentina; Belo Horizonte, Minas Gerais, Brazil; Campina Grande do Sul, Paraná, Brazil; Curitiba, Paraná, Brazil and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.