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RecruitingPHASE1INTERVENTIONAL

Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2

This research study is looking at a new treatment called ARO-ATXN2 for adults diagnosed with Spinocerebellar Ataxia Type 2 (SCA2). SCA2 is a genetic condition that affects balance and coordination. The main goal of this 'Phase 1' study is to check if the ARO-ATXN2 injection is safe for people, how well their bodies tolerate it, and how the medicine works within the body. Participants will be randomly chosen to receive either a single dose of ARO-ATXN2 or a placebo (a dummy injection that looks the same but contains no active medicine). Researchers will then carefully monitor them to understand any effects of the treatment. This is an early stage of testing new medications.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Arrowhead Pharmaceuticals
Enrolment target
36
Start
17 Dec 2024
Estimated completion
01 Dec 2026

What is this study about?

This study is an early investigation into a new potential treatment for a condition called Spinocerebellar Ataxia Type 2, or SCA2. SCA2 is a genetic condition that affects the brain, causing problems with movement, balance, and coordination. It happens because of a specific genetic change, and this study is inviting people who have this particular genetic change and are experiencing symptoms.

The new treatment being tested is an injection called ARO-ATXN2. The main purpose of this study, often called a 'Phase 1' study, is to find out if the ARO-ATXN2 injection is safe for people with SCA2 and how well their bodies can cope with it. Researchers also want to understand how the drug moves through the body and what effects it might have at a cellular level.

Participants in this study will be randomly assigned to receive either the ARO-ATXN2 injection or a placebo injection. A placebo is a treatment that looks exactly like the real thing but contains no active medication. This helps researchers compare the effects of the active drug to no treatment at all. All participants will be closely monitored after receiving their injection.

Key takeaways

  • It's an early-stage (Phase 1) study for Spinocerebellar Ataxia Type 2 (SCA2).
  • It's testing a new injection called ARO-ATXN2 for safety and how the body handles it.
  • Participants will receive either the active drug or a placebo (dummy injection).
  • The treatment is given via a single injection into the spinal fluid.
  • Close medical monitoring will happen throughout the study.

Who may be eligible?

To join this study, you must be an adult aged between 18 and 65 years old. You need to have a confirmed diagnosis of Spinocerebellar Ataxia Type 2 (SCA2) and carry a specific genetic marker (at least 33 CAG repeats in the ATXN2 gene), which will be checked from your medical records or a genetic test.

There are also some health conditions that would prevent you from taking part. For instance, if you are pregnant or breastfeeding, you cannot join. People with certain uncontrolled health issues like very high blood pressure, serious heart, liver, or kidney disease, or specific infections like HIV or hepatitis B or C, would not be suitable.

Additionally, if you’ve had stem cell therapy previously, have a learning disability, or any problem that would make a procedure called a 'lumbar puncture' unsafe, you wouldn't be able to participate. If you're a woman who could become pregnant, you would need to agree to use effective birth control during and for some time after the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 to 65?
  2. Do you have a confirmed diagnosis of SCA2?
  3. Are you able to use effective birth control if you are a woman of childbearing potential?
  4. Do you have any serious health conditions like uncontrolled high blood pressure or severe heart, liver, or kidney problems?
  5. Have you ever received stem cell therapy?
  6. Are you able to safely have a procedure called a 'lumbar puncture'?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you're eligible. If you are, you would then be randomly assigned to receive either the ARO-ATXN2 injection or a placebo (a dummy injection). This will be a single injection administered through a 'lumbar puncture', which is a procedure where a small needle is inserted into your lower back to deliver the medicine into the fluid around your spinal cord.

After the injection, you would have several follow-up appointments. These visits will involve various tests and checks to monitor your health, look for any side effects, and see how your body is reacting to the treatment. This includes checking your general health, possibly having blood tests, and further assessments of your SCA2 symptoms. The total duration of your involvement in the study would be outlined by the study team.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to scientific understanding of SCA2 and potentially new treatments, and receiving close medical monitoring. However, there are also potential risks, including side effects from the ARO-ATXN2 injection or the lumbar puncture procedure itself, which could include headache or discomfort. It's important to remember that this is an early-stage study, and the new treatment might not be effective or could have unknown side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

  • Research Site 8
    Verified postcode
    Sydney, Australia· Recruiting
  • Research Site 7
    Verified postcode
    Melbourne, Australia· Recruiting
  • Research Site 2
    Verified postcode
    Montreal, Canada· Recruiting
  • Research Site 1
    Verified postcode
    Montreal, Canada· Recruiting
  • Research Site 9
    Verified postcode
    Edmonton, Canada· Recruiting
  • Research Site 15
    Verified postcode
    Paris, France· Recruiting
  • Research Site 13
    Verified postcode
    Tübingen, Germany· Recruiting
  • Research Site 14
    Verified postcode
    Ulm, Germany· Recruiting
  • Research Site 16
    Verified postcode
    Milan, Italy· Recruiting
  • Research Site 4
    Verified postcode
    Auckland, New Zealand· Recruiting
  • Research Site 3
    Verified postcode
    Christchurch, New Zealand· Recruiting
  • Research Site 10
    Verified postcode
    Barcelona, Spain· Recruiting

Common questions

What is Spinocerebellar Ataxia Type 2 (SCA2)?

SCA2 is a genetic condition that affects the brain, causing problems with balance, coordination, and movement.

What is a 'placebo'?

A placebo is adummy treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the new treatment's effects.

What is a 'lumbar puncture'?

This is a medical procedure where a thin needle is gently inserted into your lower back to deliver medicine into the fluid surrounding your spinal cord.

Will I know if I'm getting the real drug or the placebo?

No, you won't know at the time. This is done so that the results are not influenced by what you expect. The researchers also won't know immediately.

How long will I be in the study?

The study team will tell you the exact length of your participation, including follow-up visits, during the consent process.

How to find out more

Medical Monitor

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of ARO-ATXN2 Injection in Adults With Spinocerebellar …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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