A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Small Fiber Neuropathy

In brief

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.

Key facts

Study ID

NCT03304522

Run by

Vertex Pharmaceuticals Incorporated

People needed

89

Starts

2017-09-20

Expected to finish

2018-11-08

Last updated by the study team

2021-11-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
• Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months prior to screening
• Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at screening
• Normal nerve conduction studies (NCS), including presence of sural response.
• Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1

You may not qualify if…

• History in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
• History of connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis, Fabry's disease, celiac disease, lyme disease, autoimmune disorders
• A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
• Current clinically significant liver or kidney dysfunction
• Current uncontrolled thyroid dysfunction
• A diagnosis of diabetes, HbA1C ≥8% at screening
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• Concomitant severe pain conditions which may impair self-assessment of pain due to small fiber neuropathy
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Xenoscience Inc. - 21st Century Neurology — Phoenix, Arizona, United States
• Phoenix Neurological Associates, Ltd. — Phoenix, Arizona, United States
• Sutter Health - Alta Bates Summit Medical Center - The Jordan Research & Education Institute — Berkeley, California, United States
• Neuropain Medical Center — Fresno, California, United States
• University of California San Diego — La Jolla, California, United States
• SDS Clinical Trials, Inc. — Orange, California, United States
• Stanford University School of Medicine — Redwood City, California, United States
• Blue Sky Neurology — Englewood, Colorado, United States
• Bioclinica Research - Orlando — Orlando, Florida, United States
• Infinity Clinical Research — Sunrise, Florida, United States
• Southern Illinois University (SIU) School of Medicine — Springfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
• International Clinical Research Institute (ICRI) — Overland Park, Kansas, United States
• River Cities Clinical Research Center — Shreveport, Louisiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center (DHMC) — Lebanon, New Hampshire, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• Albany Medical Center- Neurology Group — Albany, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina School of Medicine — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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