A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)

NCT02365636 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TV-45070-CNS-20013
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 77

Brief Summary

This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures

  The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be recorded (non-missing) or the daily average was considered missing. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.

  Baseline (day -7 to day -1), Week 4 (day 22 to day 28)

Secondary Outcomes (12)

• Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures

  Baseline (day -7 to day -1), Week 4 (day 22 to day 28)

• Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures

  Baseline (day -7 to day -1), Week 4 (day 22 to day 28)

• Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures

  Baseline (day -7 to day -1), Week 4 (day 22 to day 28)

• Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures

  Baseline (day -7 to day -1), Week 4 (day 22 to day 28)

• Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM)

  Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)

Study Arms (3)

TV-45070 4%

EXPERIMENTAL

TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.

Drug: TV-45070

TV-45070 8%

EXPERIMENTAL

TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.

Drug: TV-45070

Placebo

PLACEBO COMPARATOR

Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.

Drug: Placebo

Interventions

TV-45070 DRUG

TV-45070 is an ointment applied topically twice daily to area of pain.

Also known as: funapide, XEN402

TV-45070 4%; TV-45070 8%

Placebo DRUG

The matching placebo ointment contained only the excipients of the active treatment; also applied topically twice daily to area of pain.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
• Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
• If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
• If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
• Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.
• Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study
• Other criteria apply, please contact the investigator for more information

You may not qualify if:

• Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
• Patient has PHN affecting the face (trigeminal nerve distribution).
• Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
• Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
• Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.
• Patient has a history of fibromyalgia.
• Other criteria apply, please contact the investigator for more information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (77)

Teva Investigational Site 13052

Birmingham, Alabama, 35213, United States

Location

Teva Investigational Site 13086

Mobile, Alabama, 36608, United States

Location

Teva Investigational Site 13514

Phoenix, Arizona, 85018, United States

Location

Teva Investigational Site 13520

Phoenix, Arizona, 85023, United States

Location

Teva Investigational Site 13661

Little Rock, Arkansas, 72205, United States

Location

Teva Investigational Site 13079

Colton, California, 92324, United States

Location

Teva Investigational Site 13331

Pomona, California, 91767, United States

Location

Teva Investigational Site 13341

Sacramento, California, 95821, United States

Location

Teva Investigational Site 13051

Santa Monica, California, 90404, United States

Location

Teva Investigational Site 13055

Thousand Oaks, California, 91360, United States

Location

Teva Investigational Site 13100

Torrance, California, 90505, United States

Location

Teva Investigational Site 13657

Milford, Connecticut, 06460, United States

Location

Teva Investigational Site 13521

Brandon, Florida, 33511, United States

Location

Teva Investigational Site 13085

Brooksville, Florida, 34601, United States

Location

Teva Investigational Site 13057

Clearwater, Florida, 33761, United States

Location

Teva Investigational Site 13084

Fort Myers, Florida, 33912, United States

Location

Teva Investigational Site 13047

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 13046

Homestead, Florida, 33030, United States

Location

Teva Investigational Site 13098

Jacksonville, Florida, 32256, United States

Location

Teva Investigational Site 13045

Kissimmee, Florida, 34744, United States

Location

Teva Investigational Site 13064

Miami, Florida, 33126, United States

Location

Teva Investigational Site 13338

Miami, Florida, 33135, United States

Location

Teva Investigational Site 13044

Miami, Florida, 33176, United States

Location

Teva Investigational Site 13335

Miami, Florida, 33183, United States

Location

Teva Investigational Site 13522

Naples, Florida, 34102, United States

Location

Teva Investigational Site 13058

New Port Richey, Florida, 34652, United States

Location

Teva Investigational Site 13076

Oldsmar, Florida, 34677, United States

Location

Teva Investigational Site 13073

Orlando, Florida, 32801, United States

Location

Teva Investigational Site 13048

Orlando, Florida, 32806, United States

Location

Teva Investigational Site 13659

Pembroke Pines, Florida, 33024, United States

Location

Teva Investigational Site 13519

Seminole, Florida, 33708, United States

Location

Teva Investigational Site 13056

St. Petersburg, Florida, 33713, United States

Location

Teva Investigational Site 13059

Tampa, Florida, 33603, United States

Location

Teva Investigational Site 13329

Venice, Florida, 34292, United States

Location

Teva Investigational Site 13513

Virginia Gardens, Florida, 33172, United States

Location

Teva Investigational Site 13053

Atlanta, Georgia, 30331, United States

Location

Teva Investigational Site 13063

Marietta, Georgia, 30060, United States

Location

Teva Investigational Site 13091

Aurora, Illinois, 60506, United States

Location

Teva Investigational Site 13072

Bolingbrook, Illinois, 60490, United States

Location

Teva Investigational Site 13062

Evansville, Indiana, 47714, United States

Location

Teva Investigational Site 13093

Evansville, Indiana, 47725, United States

Location

Teva Investigational Site 13074

Monroe, Louisiana, 71201, United States

Location

Teva Investigational Site 13660

Shreveport, Louisiana, 71105, United States

Location

Teva Investigational Site 13094

Brockton, Massachusetts, 02301, United States

Location

Teva Investigational Site 13061

Detroit, Michigan, 48235, United States

Location

Teva Investigational Site 13049

Farmington Hills, Michigan, 48334, United States

Location

Teva Investigational Site 13099

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 13065

Las Vegas, Nevada, 89123, United States

Location

Teva Investigational Site 13066

Albuquerque, New Mexico, 87102, United States

Location

Teva Investigational Site 13330

Albuquerque, New Mexico, 87108-5129, United States

Location

Teva Investigational Site 13658

Albany, New York, 12208, United States

Location

Teva Investigational Site 13334

Brooklyn, New York, 11229, United States

Location

Teva Investigational Site 13054

New York, New York, 10128, United States

Location

Teva Investigational Site 13083

North Massapequa, New York, 11758-1802, United States

Location

Teva Investigational Site 13060

Calabash, North Carolina, 28467, United States

Location

Teva Investigational Site 13337

Raleigh, North Carolina, 27612, United States

Location

Teva Investigational Site 13082

Winston-Salem, North Carolina, 27103, United States

Location

Teva Investigational Site 13089

Columbus, Ohio, 43214, United States

Location

Teva Investigational Site 13075

Oklahoma City, Oklahoma, 73103, United States

Location

Teva Investigational Site 13328

Oklahoma City, Oklahoma, 73104, United States

Location

Teva Investigational Site 13516

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 13078

Eugene, Oregon, 97404, United States

Location

Teva Investigational Site 13333

Levittown, Pennsylvania, 19056, United States

Location

Teva Investigational Site 13339

Philadelphia, Pennsylvania, 19146, United States

Location

Teva Investigational Site 13327

Pittsburgh, Pennsylvania, 15206, United States

Location

Teva Investigational Site 13332

Charleston, South Carolina, 29406, United States

Location

Teva Investigational Site 13068

Rapid City, South Dakota, 57702, United States

Location

Teva Investigational Site 13095

Knoxville, Tennessee, 37909, United States

Location

Teva Investigational Site 13096

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 13070

Arlington, Texas, 76012, United States

Location

Teva Investigational Site 13088

Austin, Texas, 78731, United States

Location

Teva Investigational Site 13340

McKinney, Texas, 75071, United States

Location

Teva Investigational Site 13050

Plano, Texas, 75093, United States

Location

Teva Investigational Site 13518

Salt Lake City, Utah, 84124, United States

Location

Teva Investigational Site 13090

Norfolk, Virginia, 23507, United States

Location

Teva Investigational Site 13081

Bellevue, Washington, 98007, United States

Location

Teva Investigational Site 13336

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Fetell M, Sendel M, Li T, Marinelli L, Vollert J, Ruggerio E, Houk G, Dockum M, Albrecht PJ, Rice FL, Baron R. Cutaneous nerve fiber and peripheral Nav1.7 assessment in a large cohort of patients with postherpetic neuralgia. Pain. 2023 Nov 1;164(11):2435-2446. doi: 10.1097/j.pain.0000000000002950. Epub 2023 Jun 27.

  PMID: 37366590 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

TV-45070

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 19, 2015
• Study Start: February 26, 2015
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: November 9, 2021
• Results First Posted: October 23, 2018

Record last verified: 2021-11

Locations

US (77)