In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo. Trial details include: * Trial duration: 22-23 weeks; * Treatment duration: 1 injection visit with a 20-week follow-up period; * Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Merz Investigational Site #3590004
Plovdiv, Bulgaria
Merz Investigational Site #3590006
Sofia, Bulgaria
Merz Investigational Site #3590005
Sofia, Bulgaria
Merz Investigational Site #3590002
Sofia, Bulgaria
Merz Investigational Site #3590003
Veliko Tarnovo, Bulgaria
Merz Investigational Site #0330066
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Time frame: Baseline to week 2 to 12
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Time frame: Baseline to week 2 to 12
Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
Time frame: Baseline to week 20
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Boulogne-Billancourt, France
Merz Investigational Site #0330065
Limoges, France
Merz Investigational Site #0330067
Nîmes, France
Merz Investigational Site #0490174
Essen, Germany
Merz Investigational Site #0490386
Frankfurt, Germany
...and 21 more locations