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Investigational Drug for Spinocerebellar Ataxia (STRIDES Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Seelos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of SCA3 with documented genetic confirmation.
Men and women, 18 to 75 years (inclusive) of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 13, 26, 39, and 52 weeks
Awards & highlights
STRIDES Trial Summary
This trial is testing a new drug to see if it is safe and effective for treating adults with spinocerebellar ataxia, a degenerative neurological disorder.
Who is the study for?
Adults aged 18-75 with a clinical diagnosis of Spinocerebellar Ataxia type 3 (SCA3), confirmed genetically, and an m-SARA score ≥4 can join. Participants must have stable medication use for the past month, a BMI between 18-35 kg/m2, and agree to contraception guidelines. Exclusions include diabetes treatment, chronic liver disease or infections like HIV/Hepatitis B/C, recent drug/alcohol abuse, other medical conditions that could affect results or pose risks.Check my eligibility
What is being tested?
The STRIDES study is testing SLS-005 (trehalose injection) against a placebo in adults with spinocerebellar ataxia. This Phase 2b/3 trial randomly assigns participants to either the investigational drug or placebo group in equal numbers without them knowing which one they're getting to measure its safety and effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed here, potential side effects may include reactions related to intravenous infusions such as discomfort at the injection site, allergic reactions, and systemic responses depending on how the body tolerates trehalose.
STRIDES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been genetically confirmed to have SCA3.
Select...
I am between 18 and 75 years old.
Select...
I have been genetically confirmed to have SCA3.
STRIDES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4, 13, 26, 39, and 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 13, 26, 39, and 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy: m-SARA
Secondary outcome measures
Efficacy: CGI-S
Efficacy: FARS-ADL
Efficacy: PGI-S
+2 moreSTRIDES Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: SLS-005 0.75 g/kg DoseExperimental Treatment1 Intervention
SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.75 g/kg by IV infusion once a week.
For 52 weeks
Group II: SLS-005 0.50 g/kg DoseExperimental Treatment1 Intervention
SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.50 g/kg by IV infusion once a week.
For 52 weeks
Group III: Placebo volume equivalent to a SLS-005 0.75 g/kg dose calculationPlacebo Group1 Intervention
Placebo (sodium chloride injection, 0.9, USP) will be administered by IV infusion once a week as a weight-based volume equivalent to a SLS-005 0.75 g/kg dose.
For 52 weeks
Group IV: Placebo volume equivalent to a SLS-005 0.50 g/kg dose calculationPlacebo Group1 Intervention
Placebo (sodium chloride injection, 0.9, USP) will be administered by IV infusion once a week as a weight-based volume equivalent to a SLS-005 0.50 g/kg dose.
For 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLS-005
2022
Completed Phase 3
~170
Find a Location
Who is running the clinical trial?
Seelos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
407 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) falls between 18 and 35 kilograms per square meter.I am between 18 and 75 years old.If you have any other medical condition or issue that could make it hard for the study team to collect accurate safety or effectiveness data or might put you at risk during the study, you may not be able to participate.I have been genetically confirmed to have SCA3.You have a score of 4 or more on a test that measures your symptoms.I have never been treated with SLS-005 or similar drugs, nor am I allergic to trehalose.I have had liver injury from medication or my liver tests are not normal.Your body mass index (BMI) falls between 18 and 35.I do not have any significant heart problems that could make participating unsafe.My kidney function is not adequate, with a creatinine clearance of less than 60 mL/min.I am willing to follow the study's rules on sexual activity or birth control.My medication doses have been the same for the last 30 days.I have been diagnosed with or am being treated for type 1 or type 2 diabetes.I have chronic liver disease or HIV, or I had Hepatitis B or C but it was successfully treated.You have a history of abusing drugs or alcohol within the past two years.You scored 4 or higher on a test called m-SARA during the screening visit.My ataxia is not genetically confirmed as SCA type 3 and is not due to conditions like alcoholism or head injury.You are not currently participating in another clinical trial or completed one less than 30 days ago (90 days if it involved a biological treatment).You have answered "yes" to questions about suicidal thoughts or behavior in the past 6 months or 3 years on a test called the Columbia Suicide Severity Rating Scale (C-SSRS).I am between 18 and 75 years old.I have been genetically confirmed to have SCA3.You have a mental or cognitive disorder that might affect your ability to understand the study or complete the necessary assessments.
Research Study Groups:
This trial has the following groups:- Group 1: SLS-005 0.75 g/kg Dose
- Group 2: SLS-005 0.50 g/kg Dose
- Group 3: Placebo volume equivalent to a SLS-005 0.75 g/kg dose calculation
- Group 4: Placebo volume equivalent to a SLS-005 0.50 g/kg dose calculation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest number of people who can enroll in this research project?
"Yes, this is an ongoing trial that is still recruiting patients, as of October 11th, 2022. The trial was first posted on June 3rd, 2022 and is looking for 245 patients total, at 7 different sites."
Answered by AI
Are individuals who are over the age of 30 allowed to participate in this research project?
"This particular clinical trial requires that applicants are aged 18 to 75. While there are 19 clinical trials for patients that are younger and 33 for patients that are older, this is the only study with these age requirements."
Answered by AI
Are there any specific patients this study is designed for?
"The researchers conducting this trial are looking for 245 individuals that have spinocerebellar ataxia type 3 and are between 18-75 years old. The applicants must also meet the following requirements: Be able to provide informed consent, be of either gender, have a BMI between 18-35 kg/m2, have been taking the same doses of medication for the past 30 days, have a negative pregnancy test for female participants of childbearing potential, and be willing to comply with sexual abstinence or contraception guidelines."
Answered by AI
Are participants being sought for this experiment currently?
"That is correct, the online information specifies that the clinical trial is looking for enrollees. The trial was first posted on June 3rd, 2022 and was last updated on October 11th, 2022. There is a need for 245 patients at 7 sites."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of South Florida
UCHealth Neurosciences Center - Anschutz Medical Campus
Swedish Neuroscience Specialists - Movement Disorders
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- University of South Florida: < 48 hours
Average response time
- < 2 Days
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