STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia (NCT05490563) | Clinical Trial Compass
TerminatedPhase 2/3
STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia
Stopped: This was a business decision due to financial considerations, not based on data related to safety or therapeutic effects.
United States23 participantsStarted 2022-06-03
Plain-language summary
Phase 2b/3 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed informed consent.
✓. Men and women, 18 to 75 years (inclusive) of age.
✓. Clinical diagnosis of SCA3 with documented genetic confirmation.
✓. m-SARA total score ≥ 4 at the screening visit.
✓. m-SARA gait component score ≥ 1 at the screening visit.
✓. Body Mass Index (BMI) between 18 kg/m2 and 35 kg/m2 (inclusive).
✓. Stable doses of all concomitant medications for at least 30 days prior to the screening visit.
✓. Negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy result at the screening visit for female participants of childbearing potential.
Exclusion criteria
✕. 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.
✕. A score of 4 on any 1 of the 4 items that comprise the m-SARA.
✕. 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).