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

NCT04245371 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: CTS2020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference

  The minimum score is 11 indicating low symptom severity and the maximum score is 55 which would indicate high symptom severity.

  After 1 Week of Treatment

Secondary Outcomes (3)

• Functional Status Score (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ):minimally clinically important difference

  After 1 Week of Treatment

• Sensory examination

  After 1 Week of Treatment

• Pain Detect Questionnaire

  After 1 Week of Treatment

Study Arms (2)

Active

ACTIVE COMPARATOR

Lidocaine Patch 1.8% applied to affected hand at night for 2 weeks following FDA approved dosing recommendations, i.e. 12 hours during each 24-hour daily cycle.

Drug: Lidocaine 1.8%

Placebo

PLACEBO COMPARATOR

Placebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle.

Drug: Placebo

Interventions

Lidocaine 1.8% DRUG

Topical Patch

Active

Placebo DRUG

Matching Placebo Patch

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants, 18 years or older at Screening;
• Participants with Carpal Tunnel Syndrome, confirmed by CT6;
• 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.

You may not qualify if:

• 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 30 days;
• 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;

Sponsors & Collaborators

• John Papakonstantinou, MD: lead
• Scilex Ltd.: collaborator

Study Sites (1)

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, 48307, United States

Location

Related Publications (8)

• Chung SY, Kwak JM, Kang S, Son SH, Kim JD, Yoon JS. Predictive Variables for Sonographically Guided Corticosteroid Injection in Mild-to-Moderate Carpal Tunnel Syndrome. Ann Rehabil Med. 2018 Apr;42(2):213-221. doi: 10.5535/arm.2018.42.2.213. Epub 2018 Apr 30.

  PMID: 29765874 BACKGROUND

• Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.

  PMID: 30343858 BACKGROUND

• Moghtaderi AR, Jazayeri SM, Azizi S. EMLA cream for carpal tunnel syndrome: how it compares with steroid injection. Electromyogr Clin Neurophysiol. 2009 Sep-Oct;49(6-7):287-9.

  PMID: 19845100 BACKGROUND

• Leppert W, Malec-Milewska M, Zajaczkowska R, Wordliczek J. Transdermal and Topical Drug Administration in the Treatment of Pain. Molecules. 2018 Mar 17;23(3):681. doi: 10.3390/molecules23030681.

  PMID: 29562618 BACKGROUND

• Sears ED, Meerwijk EL, Schmidt EM, Kerr EA, Chung KC, Kamal RN, Harris AHS. Variation in Nonsurgical Services for Carpal Tunnel Syndrome Across a Large Integrated Health Care System. J Hand Surg Am. 2019 Feb;44(2):85-92.e1. doi: 10.1016/j.jhsa.2018.11.002. Epub 2018 Dec 20.

  PMID: 30579690 BACKGROUND

• Okamura A, Guidetti BC, Caselli R, Borracini JA, Moraes VY, Belloti JC. HOW DO BOARD-CERTIFIED HAND SURGEONS MANAGE CARPAL TUNNEL SYNDROME? A NATIONAL SURVEY. Acta Ortop Bras. 2018 Jan-Feb;26(1):48-53. doi: 10.1590/1413-785220182601181880.

  PMID: 29977145 BACKGROUND

• Graham B. The value added by electrodiagnostic testing in the diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2008 Dec;90(12):2587-93. doi: 10.2106/JBJS.G.01362.

  PMID: 19047703 BACKGROUND

• Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J. 2008 Jan;77(1):6-17.

  PMID: 18269111 BACKGROUND

Related Links

• FULL PRESCRIBING INFORMATION of ZTLIDO (lidocaine topical system) 1.8%

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• John Papakonstantinou, MD

  Michigan Orthopaedic & Spine Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Hand and Upper Extremity Surgeon

Model Details: Participants will serve as their own control

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 28, 2020
• Study Start: February 24, 2020
• Primary Completion: May 7, 2023
• Study Completion: May 7, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)