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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05490563




Registration number
NCT05490563
Ethics application status
Date submitted
3/08/2022
Date registered
5/08/2022

Titles & IDs
Public title
STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia
Scientific title
A Double-blind, Randomized, Placebo Controlled, Trial to Assess Safety and Efficacy of SLS-005 (Trehalose Injection, 90.5 mg/mL for Intravenous Infusion) for the Treatment of Adults With Spinocerebellar Ataxia
Secondary ID [1] 0 0
SLS-005-302
Universal Trial Number (UTN)
Trial acronym
STRIDES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinocerebellar Ataxia Type 3 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SLS-005
Treatment: Drugs - Placebo

Experimental: SLS-005 0.75 g/kg Dose - 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

Experimental: SLS-005 0.50 g/kg Dose - 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

Placebo comparator: Placebo volume equivalent to a SLS-005 0.75 g/kg dose calculation - 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

Placebo comparator: Placebo volume equivalent to a SLS-005 0.50 g/kg dose calculation - 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: Drugs: SLS-005
SLS-005

Treatment: Drugs: Placebo
Placebo (sodium chloride injection, 0.9%, USP)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy: m-SARA
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Efficacy: CGI-S
Timepoint [1] 0 0
4, 13, 26, 39, and 52 weeks
Secondary outcome [2] 0 0
Efficacy: PGI-S
Timepoint [2] 0 0
4, 13, 26, 39, and 52 weeks
Secondary outcome [3] 0 0
Efficacy: FARS-ADL
Timepoint [3] 0 0
4, 13, 26, 39, and 52 weeks
Secondary outcome [4] 0 0
Efficacy: m-SARA
Timepoint [4] 0 0
26 weeks
Secondary outcome [5] 0 0
Efficacy: m-SARA
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Safety: Adverse Events
Timepoint [6] 0 0
56 weeks

Eligibility
Key inclusion criteria
1. Signed informed consent.
2. Men and women, 18 to 75 years (inclusive) of age.
3. Clinical diagnosis of SCA3 with documented genetic confirmation.
4. m-SARA total score = 4 at the screening visit.
5. m-SARA gait component score = 1 at the screening visit.
6. Body Mass Index (BMI) between 18 kg/m2 and 35 kg/m2 (inclusive).
7. Stable doses of all concomitant medications for at least 30 days prior to the screening visit.
8. Negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy result at the screening visit for female participants of childbearing potential.
9. Willingness to comply with sexual abstinence or contraception guidelines of this study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any hereditary ataxia that is not genetically confirmed to be SCA type 3, or any type of ataxia that is acquired or secondary to another medical condition including but not limited to, alcoholism, head injury, multiple sclerosis, olivopontocerebellar atrophy, multiple system atrophy, or stroke.
2. A score of 4 on any 1 of the 4 items that comprise the m-SARA.
3. Current participation in another clinical trial or completed participation in an interventional trial less than 30 days prior to the screening visit (90 days for a biological treatment).
4. Current diagnosis and/or healthcare professional-recommended treatment (medication and/or diet) of diabetes mellitus type 1 or type 2.
5. Hemoglobin A1c (HbA1c) = 6.5% at the screening visit
6. Prior treatment with SLS-005, any other IV trehalose formulation, or known hypersensitivity to trehalose.
7. Pregnant or breastfeeding.
8. History of alcohol or drug abuse within the last 2 years.
9. Chronic liver disease including Hepatitis B; Hepatitis C unless successful curative treatment is documented; human immunodeficiency virus (HIV) infection.
10. Prior history of drug-induced liver injury (DILI) and/or laboratory results at screening that indicate inadequate liver function (e.g., alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT] > 2 times the upper limit of normal [x ULN] and/or total bilirubin level > 2 x ULN).
11. Laboratory results at screening that indicate inadequate renal function (e.g., estimated creatinine clearance of < 60 mL/min calculated by the Cockcroft and Gault formula).
12. Any current cardiovascular disease or abnormality on 12-lead ECG at screening that, in the investigator's opinion, is clinically significant and could be a potential safety risk to the participant.
13. Any current psychiatric, neurological, or cognitive disorder that, in the investigator's opinion, may interfere with the participant's ability to provide informed consent or appropriately complete the study's safety or efficacy assessments.
14. Significant suicide risk as indicated by a "yes" response to question #4 or #5 under Suicidal Ideation in the past 6 months or any "yes" response under Suicidal Behavior in the past 3 years on the Columbia Suicide Severity Rating Scale (C-SSRS) during the screening visit.
15. Any other medical condition or abnormal finding during screening that, in the investigator's opinion, could confound collection or interpretation of safety or efficacy data or be a potential safety risk to the participant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/11/2023
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Brazil
State/province [8] 0 0
RS
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Germany
State/province [10] 0 0
Saxonia
Country [11] 0 0
Germany
State/province [11] 0 0
Tuebingen
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Portugal
State/province [13] 0 0
Coimbra
Country [14] 0 0
Portugal
State/province [14] 0 0
Lisboa
Country [15] 0 0
Portugal
State/province [15] 0 0
Porto
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seelos Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05490563