Phase 2 N=11 Randomized Single-blind Treatment

Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy

Idiopathic Small Fiber Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT02607254 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Visual Analogue Score for Pain Intensity. — 7.1; 6.9; 7.3; 5.4 score on visual analogue score

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pregabalin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analogue Score for Pain Intensity.	7.1; 6.9; 7.3; 5.4; 5.1; 7.6	—
SECONDARY Brief Pain Inventory (BPI sf);	6.7; 6.3; 7.2; 4.9; 4.5; 6.8	—
SECONDARY Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);	4.5; 5.3; 5.9; 3.1; 2.8; 5.1	—
SECONDARY Patient Global Impression of Change (PGIC);	4.1; 5.4; 1.8; 3.9; 4.2; NA	—

Summary

The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.

Eligibility Criteria

Inclusion Criteria

Subjects with idiopathic predominate-small fiber neuropathy
Subject must have chronic peripheral neuropathic pain for more than 3 months
A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;
Show increase in pain intensity scores during the wash off period;
Age older than 18 years;

Exclusion Criteria

Subjects with large-fiber predominant neuropathy
Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g. chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective tissue disorders, hepatitis C, Fabry disease, and diabetes;
Subjects with uncontrolled thyroid or B12 disorders
Subjects with Complex Regional Pain Syndrome
Allergy to Pregabalin
Subjects at risk of suicide or self harm
Subjects with any clinically unstable cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy, symptomatic peripheral vascular disease including intermittent claudication, pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.
History of known analgesic, alcohol or illicit drug abuse within 12 months of first visit;
Pregnant females; breastfeeding females.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02607254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.