Lidocaine Patch 1.8% for Moderate to Severe Pain From Carpal Tunnel Syndrome

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine the efficacy of Lidocaine Patch 1.8% in reducing the severity of symptoms in participants with moderate-to-severe pain from Carpal Tunnel Syndrome.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John Papakonstantinou, MD
• Collaborator: Scilex Ltd.
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to be eligible for enrollment into the study:

• Male and female participants, 18 years or older at Screening;

• Participants with Carpal Tunnel Syndrome, confirmed by Electromyography (EMG);

• Pain score of at least 4, based on an 11-point numeric rating scale (NRS) (scale of 0-10), at the screening (baseline) visit;

• Able and willing to provide a written informed consent;

• Able and willing to follow study instructions;

• Able and willing to return to clinic for follow-up visits;

• Able and willing to complete a daily diary;

• Intact skin over the affected wrist;

• Woman of childbearing age agreeing to use 2 forms of contraception.

Exclusion Criteria:

Participants presenting with any of the following exclusion criteria will not be enrolled into the study

• Participants must NOT have had prior steroid injection for CTS, CTS surgery, or other intervention/injury to the wrist that might interfere with assessments in the previous 6 months;

• Participants must not have pain at other sites that interfere with their ability to report site-specific pain related to the study (bilateral CT is an exclusion);

• Participants must NOT have cognitive or psychological impairment that interferes with the ability to complete study related assessments;

• Participants with mild (NRS less than 4) or no pain (only numbness) at baseline prior to randomization;

• Opioid tolerance (receiving at least 1 week of oral morphine 60 mg/day OR transdermal fentanyl 25 mcg/hour OR oral oxycodone 30 mg/day OR oral hydromorphone 8 mg/day OR an equianalgesic dose of any other opioid);

• History of sensitivity or allergy to lidocaine or ZTLIDO;

• Irritated, abraded, or otherwise non-intact skin over the affected wrist;

• Concurrently taking tocainide, mexiletine, or local anesthetics;

• Participants with history of or at significant risk for methemoglobinemia;

• Participation in another study of investigational drugs or devices within 30 days before screening, or previous participation in a Lidocaine Patch study;

• Known to or suspected of not being able to comply with the study protocol;

• Any clinically significant condition that would, in the investigator's opinion, preclude study participation for instance alcohol, medication or drug dependency, neurotic personality, psychiatric illness, epilepsy or suicide risk;

• Pregnancy or nursing mother;

• Woman in childbearing age without satisfactory contraception;

• Presence of possible other cause/s for hand pain (i.e., radicular pain, arthritis, injury, surgery) that could confound assessment or self-evaluation of the pain due to Carpal Tunnel Syndrome;

• Participants using topically applied analgesic compounds on the affected area;

• Participants with bilateral CTS.