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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Postherpetic Neuralgia

Treatments: Drug: TV-45070; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02365636

TV-45070-CNS-20013

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

TV-45070 4%

Experimental group

Description:

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.

Treatment:

Drug: TV-45070

TV-45070 8%

Experimental group

Description:

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.

Treatment:

Drug: TV-45070

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo