Study of Sulfasalazine in Treating Painful Neuropathy

Mass General Brigham

Status and phase: Terminated; Phase 2

Conditions: Painful Neuropathy

Treatments: Drug: placebo; Drug: Sulfasalazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01667029

2012-p-001443

Details and patient eligibility

About

The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Painful neuropathy
• Michigan Neuropathy Screening Instrument score of 3 or greater
• no obvious alternative explanation for neuropathy
• average baseline pain > 4/10

Exclusion criteria

• other severe pain
• anticipated difficulty weaning off medications
• past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
• medical contraindication to sulfasalazine
• not proficient in English (due to heavy use of questionaires)
• pregnant or breast feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

sulfasalazine

Experimental group

Description:

1 g oral twice daily for 2 weeks

Treatment:

Drug: Sulfasalazine

placebo

Placebo Comparator group

Description:

oral placebo pill twice daily for two weeks.

Treatment:

Drug: placebo