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



Status:Completed
Conditions:Postherpatic Neuralgia
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:February 26, 2015
End Date:May 9, 2017

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Postherpetic Neuralgia.

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


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
We found this trial at
78
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Sacramento, California
627
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Sacramento, CA
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2353
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Albany, NY
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Albuquerque, New Mexico 87102
1184
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Albuquerque, NM
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Albuquerque, New Mexico 87102
1184
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Arlington, TX
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Atlanta, GA
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1704
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Aurora, IL
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Austin, TX
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Bellevue, Washington
6
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Birmingham, Alabama
2079
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Bolingbrook, Illinois
1718
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2533
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Brandon, FL
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Brockton, Massachusetts
2495
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Brooklyn, New York
2407
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Brooksville, Florida 34601
2501
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Calabash, North Carolina
2439
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Calabash, NC
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Charleston, South Carolina
2423
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Charleston, SC
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Clearwater, Florida
2511
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Clearwater, FL
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Colton, California
972
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Colton, CA
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Columbus, Ohio
2008
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Detroit, Michigan
1933
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250
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Eugene, OR
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Evansville, Indiana
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Evansville, Indiana
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Evansville, Indiana
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Farmington Hills, Michigan 48334
1913
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Fort Myers, Florida
2615
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Fort Myers, FL
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2725
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Hialeah, FL
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Homestead, Florida
2734
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Jacksonville, Florida
2452
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Kissimmee, Florida
2556
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Knoxville, Tennessee
2110
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Las Vegas, Nevada
873
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Las Vegas, NV
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Levittown, Pennsylvania
2382
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Little Rock, Arkansas 72205
1779
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Marietta, GA
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1667
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McKinney, TX
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Memphis, Tennessee
1864
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2732
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Miami, FL
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2732
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Miami, FL
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Miami, FL
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Milford, Connecticut
2428
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2151
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Mobile, AL
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1890
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Monroe, LA
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2643
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Naples, FL
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New Port Richey, Florida
2501
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New York, New York
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Norfolk, Virginia
2431
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Norfolk, VA
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North Massapequa, New York
2427
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Oklahoma City, Oklahoma
1523
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Oklahoma City, OK
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Oklahoma City, Oklahoma
1523
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Oklahoma City, Oklahoma
1523
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2513
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Oldsmar, FL
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2547
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Orlando, FL
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Pembroke Pines, Florida
2714
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Philadelphia, Pennsylvania
2373
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Philadelphia, PA
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Phoenix, Arizona
1116
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Pittsburgh, Pennsylvania
2132
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Plano, TX
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Pomona, California 91767
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Raleigh, North Carolina
2361
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Rapid City, South Dakota
949
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Saint Louis, Missouri
1720
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Saint Petersburg, Florida
2525
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Salt Lake City, Utah
701
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Salt Lake City, Utah
701
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Santa Monica, California
962
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Seattle, Washington 98105
2
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2517
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Seminole, FL
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Shreveport, Louisiana
1820
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Tampa, Florida
2527
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Thousand Oaks, California
947
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Torrance, California
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Venice, Florida 34292
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Virginia Gardens, Florida
2725
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Winston-Salem, North Carolina 27103
2273
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