A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
NCT ID: NCT03304522
Last Updated: 2021-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2017-09-20
2018-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VX-150
VX-150
Participants received VX-150 1250 milligrams (mg) once daily (qd) orally for 6 weeks.
Placebo
Placebo
Participants received placebo matched to VX-150 for 6 weeks.
Interventions
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VX-150
Participants received VX-150 1250 milligrams (mg) once daily (qd) orally for 6 weeks.
Placebo
Participants received placebo matched to VX-150 for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Duke Neurological Disorders Clinic
Durham, North Carolina, United States
Carolinas Pain Institute
Winston-Salem, North Carolina, United States
Neurology Diagnostics, Inc
Dayton, Ohio, United States
The Richter Clinic for Neurology and Neuro-Psychiatry
Tulsa, Oklahoma, United States
Carilion Clinic Neurology
Roanoke, Virginia, United States
University of Washington
Seattle, Washington, United States
Universitätsklinikum Würzburg
Würzburg, , Germany
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, , Italy
Maastricht UMC+
Maastricht, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001042-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX16-150-102
Identifier Type: -
Identifier Source: org_study_id