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Lidoderm

Phase 2

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |BrainsWay Ltd.|Last Updated: Oct 5, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment169

FDA Designations

No designations recorded

Clinical trial landscape

Lidoderm · 1 trial · 1 indication

Phase 2 1
NCT00589979Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the KneeOsteoarthritis of the Knee
COMPLETED169 Analytics
PHASE2COMPLETED
Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
Osteoarthritis of the Knee
NCT00589979169
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Study Endpoints

Primary Endpoints

Time-to-Exit From Current Study Treatment
Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation

Time-to-exit was defined as the number of days at which a patient either met the switching criterion \[a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days\] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.

Secondary Endpoints

Time-to-Exit Due to Lack of Efficacy
Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Exit Status From Current Study Treatment - Yes
Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)
Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lidoderm (Lidocaine 5% Patch)EXPERIMENTALLidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Placebo PatchPLACEBO_COMPARATORPlacebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Interventions

NameTypeDescription
Lidoderm (Lidocaine 5% Patch)DRUGTopical Patch
Placebo PatchDRUGTopical Patch
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Eligibility Criteria

Age Range37 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Key Inclusion criteria: * Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee * Body mass index (BMI) ≤40 kg/m2 * Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptom...

Countries:United States
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Competitive Landscape -Osteoarthritis 114 trials (matched to "Osteoarthritis of the Knee")

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra
Smith & Nephew plc Sponsored ADRSNN9 - Undisclosed
Stryker CorporationSYK11N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57N/AUndisclosed
Merit Medical Systems, Inc.MMSI1N/ACorticosteroid
Johnson & JohnsonJNJ1N/AUndisclosed
Abbott LaboratoriesABT1N/AUndisclosed
Enovis CorporationENOV1N/AUndisclosed
Teleflex IncorporatedTFX1 - Undisclosed
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Frequently asked questions about Lidoderm

What is Lidoderm used for in osteoarthritis of the knee?

Lidoderm is a small molecule patch being studied for the treatment of osteoarthritis of the knee. It is an investigational drug in Phase 2 clinical development, meaning it has not yet been approved for this use. The patch is applied to the knee area to potentially relieve pain associated with the condition.

What does Lidoderm target?

Lidoderm is a small molecule patch that contains lidocaine, a local anesthetic. It works by blocking sodium channels in nerve cells, which prevents the transmission of pain signals from the affected area. This mechanism is intended to provide localized pain relief when the patch is applied to the skin over the knee.

Who makes Lidoderm?

Lidoderm is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. BrainsWay is conducting clinical research to evaluate the safety and efficacy of Lidoderm for the treatment of osteoarthritis of the knee.

What phase is Lidoderm in?

Lidoderm is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of osteoarthritis of the knee. The Phase 2 trial has been completed, and the results will help determine whether further clinical studies are warranted.

What clinical trials is Lidoderm in?

Lidoderm has one completed clinical trial registered under NCT00589979, titled "Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee." This Phase 2 study enrolled 169 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Lidoderm the same as lidocaine?

Lidoderm is a patch formulation that contains lidocaine as its active ingredient. While lidocaine is the drug substance, Lidoderm refers to the specific patch delivery system being studied for osteoarthritis of the knee. The patch is designed to deliver lidocaine locally to the affected area.