Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study

What Was Tested

This randomized controlled trial paper looks at ARA-290.

Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]).

Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]).

Who Took Part

The abstract describes 22 patients taking part.

PubMed indexes the participants as middle-aged adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and pilot study.

Random assignment meant chance, not the researchers, decided who got ARA-290 and who got the comparison, which limits bias.

As a double-blind ARA-290 study, the assignments were hidden from both participants and investigators until the end.

Some patients received a placebo instead of ARA-290, giving a reference point.

It is described as a pilot, a small early test of whether a larger ARA-290 study would be practical.

What Was Measured

Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]).

Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]).

The subject headings attached to it are Nervous System Diseases, Peptides, Pilot Projects, Sarcoidosis, Sensation and Surveys and Questionnaires.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of ARA-290 in 22 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2012 (Molecular medicine (Cambridge, Mass.)), a journal based in England.

More context: the ARA-290 compound page, all human trials.