Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Small Fiber Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03304522
Start Date
September 20 2017
End Date
November 8 2018
Last Update
November 15 2021
Active Locations (34)
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1
Xenoscience Inc. - 21st Century Neurology
Phoenix, Arizona, United States, 85004
2
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States, 85251
3
Sutter Health - Alta Bates Summit Medical Center - The Jordan Research & Education Institute
Berkeley, California, United States, 94705
4
Neuropain Medical Center
Fresno, California, United States, 93710