SLS-005 for Spinocerebellar Ataxia Type 3

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Sao Paulo, Ribeirão Preto, BrazilSpinocerebellar Ataxia Type 3SLS-005 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Spinocerebellar Ataxia Type 3

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4, 13, 26, 39, and 52 weeks

Week 52
Efficacy: CGI-S
Efficacy: FARS-ADL
Efficacy: PGI-S
52 weeks
Efficacy: m-SARA
Primary Efficacy: m-SARA
56 weeks
Safety: Adverse Events

Trial Safety

Trial Design

4 Treatment Groups

SLS-005 0.75 g/kg Dose
1 of 4
SLS-005 0.50 g/kg Dose
1 of 4
Placebo volume equivalent to a SLS-005 0.75 g/kg dose calculation
1 of 4
Placebo volume equivalent to a SLS-005 0.50 g/kg dose calculation
1 of 4

Experimental Treatment

Non-Treatment Group

245 Total Participants · 4 Treatment Groups

Primary Treatment: SLS-005 · Has Placebo Group · Phase 2 & 3

SLS-005 0.75 g/kg Dose
Drug
Experimental Group · 1 Intervention: SLS-005 · Intervention Types: Drug
SLS-005 0.50 g/kg Dose
Drug
Experimental Group · 1 Intervention: SLS-005 · Intervention Types: Drug
Placebo volume equivalent to a SLS-005 0.75 g/kg dose calculation
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo volume equivalent to a SLS-005 0.50 g/kg dose calculation
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4, 13, 26, 39, and 52 weeks

Who is running the clinical trial?

Seelos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
446 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You scored 4 or higher on a test called m-SARA during the screening visit.
Your body mass index (BMI) falls between 18 and 35.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of South Florida100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%

How responsive is this trial?

Typically responds via
Phone Call50.0%
Email50.0%
Most responsive sites:
  1. University of South Florida: < 48 hours
Average response time
  • < 2 Days

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.