RecruitingPhase 1/2

Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)

United States27 participantsStarted 2025-12-04

Plain-language summary

This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain signals reaching the brain, which should reduce the refractory pain due to small fiber neuropathy (SFN).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnostic characterization of Small Fiber Neuropathy (SFN) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria.
✓. Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening.
✓. Serum sample negative for pre-existing anti-AAV9 antibodies determined by assay detection limit

Exclusion criteria

✕. Drug- and alcohol-related:
✕. Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased.
✕. History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
✕. Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1.
✕. Use of cannabinoids is not permitted.
✕. Persons with Fabry's disease, with erythromelalgia, with peripheral neuropathies due to alcohol or drug toxicity, or with diagnosed channelopathies
✕. Procedure-related:
✕. Contraindications to LP, general anesthesia or sedation

What they're measuring

Incidence and severity of treatment emergent adverse events (TEAEs)

Timeframe: 12 weeks

Trial details

NCT IDNCT06980948

SponsorSangamo Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Patient Advocacy

510-307-7266 clinicaltrials@sangamo.com

View on ClinicalTrials.gov More Chronic Neuropathic Pain trials