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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05359133
Other study ID # TTX-CINP-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 19, 2022
Est. completion date July 2026

Study information

Verified date April 2024
Source Wex Pharmaceuticals Inc.
Contact Mehran Kavoosi
Phone 6046767900
Email mehrank@wexpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To be eligible for the trial, subjects must have ongoing moderate to severe neuropathic pain related to a prior course of platinum and/or taxane chemotherapy and have no clinical evidence of actively progressive disease. The trial period will comprise a Screening period (up to 35 Days), randomization and a 4-day treatment period, followed by a 12-week follow up period (12 weeks total after initial treatment), and an End-of-Trial/Follow-up visit which will occur at Week 13. This is a study to research the effects of the study drug on neuropathic pain compared placebo.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tetrodotoxin
TTX for Injection, 30 µg/mL, is a sterile, nonpyrogenic, white, lyophilized powder provided in a 5 mL glass single-use vial with a rubber stopper and aluminum overseal. Upon reconstitution of the lyophilized product with 1.1 mL of sterile water for injection, each vial delivers 1 mL of fluid containing 30 µg of TTX with a pH of 4.0 to 5.5
Placebo
Placebo for injection is a sterile 0.9% sodium chloride injection or normal saline for injection. To ensure blinding, subjects receiving placebo will receive the same volume (1.0 mL) for injection to match the volume used for the cohorts assigned to receive active trial drug. Route and frequency: 1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days in each treatment Cycle.

Locations

Country Name City State
United States Oncology Specialists of Charlotte Charlotte North Carolina
United States Care Access Research Clifton New Jersey
United States Tina Peters Houston Texas
United States Clinical Trials of SWLA Lake Charles Louisiana
United States Care Access Research Macon Georgia
United States MEDSOL Clinical Research Center Port Charlotte Florida
United States Syrentis Clinical Research Santa Ana California
United States Providence Medical Foundation Santa Rosa California
United States SUNY Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
Wex Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other AUC up to week 12 AUC calculated on the Change from Baseline through Week 12 in weekly average NPRS scores. baseline to week 12
Other NPRS Pain reduction - weekly Change from Baseline to each study week through Week 12 in Average Weekly NPRS scores baseline to week 12
Other NPRS Pain reduction - weekly Percent Change from Baseline to each study week through Week 12 in Average Weekly NPRS scores baseline to week 12
Other Subjects with at least 30% reduction in pain Proportion of responders at Week 12, defined as subjects showing a 30% or greater reduction from overall Baseline (Week -1 & week -2) to Week 12 in weekly average NPRS score. baseline to week 12 (assessed weekly)
Other Subjects with at least 50% reduction in pain Proportion of responders at Week 12, defined as subjects showing a 30% or greater reduction from overall Baseline (Week -1 & week -2) to Week 12 in weekly average NPRS score. baseline to week 12 (assessed weekly)
Other Time to response Time to first response defined as (30%/50%) reduction from overall Baseline in weekly average NPRS score Day 1 to week 12
Other Duration of response Duration of response defined as time from initial (30%/50%) reduction from overall baseline in weekly average NPRS score to first loss of response. Day 1 to week 12
Other BPI change Change from Baseline to each study visit through Week 12 in quality of life and pain intensity measures using the Brief Pain Inventory (BPI). Baseline to Week 12
Other NPSI change Change from Baseline to each study visit through Week 12 in neuropathic pain symptoms using the Neuropathic Pain Symptoms Inventory (NPSI) Baseline to Week 12
Other POMS change Change from Baseline to each study visit through Week 12 in Profile of Mood States (POMS2) total mood disturbance, and each of the 6 specific subscales. Baseline to Week 12
Other Percent of subjects taking Rescue Medication Percentage of subjects taking allowed and prohibited rescue medication at each week, including Week 12. Baseline to Week 12
Other Average rescue medication consumed Average per-subject consumption of allowed and prohibited rescue medication at each week, including Week 12 Baseline to Week 12
Other Patient global impression of change questionnaire Subjects' Global Impression of Change responses at each visit through the End-of-Trial visit. at week 12
Other Proportion of responders (30%/50%) Proportion of responders (30%/50%) at each study week through Week 12 weekly until week 12
Primary NPRS Pain reduction - at week 4 The Change from Baseline (average of Days -14 to -1) at Week 4 in average weekly NPRS scores in subjects treated with TTX compared to Placebo At week 4
Secondary NPRS Pain reduction - at week 8 The Change from Baseline (average of Days -14 to -1) at Week 8 in average weekly NPRS scores in subjects treated with TTX compared to Placebo At week 8
Secondary NPRS Pain reduction - at week 12 The Change from Baseline (average of Days -14 to -1) at Week 12 in average weekly NPRS scores in subjects treated with TTX compared to Placebo At week 12
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