Health TrialsbyHealthPanel

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

ConditionChronic Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSangamo Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ST-503

    Genetic

    Genomic Medicine

  • Sham (No Treatment)

    Procedure/Surgery

    Sham Procedure

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Sham Controlled StudySham comparator 1 intervention
Group B: Investigational AgentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment emergent adverse events (TEAEs)

To assess safety and tolerability of ST-503 over a 12-week post-dosing observation period.

Time frame
12 weeks

Secondary outcomes

1

Percentage of subjects with pain intensity reduction from baseline at Week 12

* 30% in the weekly average of daily pain intensity measurements performed using the PI-NRS * 50% in the weekly average of daily pain intensity measurements performed using the PI-NRS * Dose of rescue medication use * Frequency of rescue medication use

Time frame
12 weeks
2

Percentage of subjects at Week 12

* Categorized as improved on the patient global impression of change (PGIC) assessment * With a ≥ 1-point improvement in suicidal ideation in Columbia Suicide Severity Rating Scale (C-SSRS) responses

Time frame
12 weeks
3

Columbia Suicide Severity Rating Scale (CSSRS) Rating

With a ≥ 1-point decline in suicidal ideation in Columbia Suicide Severity Rating Scale (CSSRS) responses

Time frame
12 weeks
4

Overall Pain Intensity Numerical Rating Scale (PI-NRS) score

Participants will rate their pain intensity using an 11-point Numerical Rating Scale (0=no pain and 10=worst possible pain) and record their score in an electronic diary.

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sangamo Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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