A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)

NCT01195636 | Completed Phase 2 Results

• 1 other identifier: XPF-002-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment of pain in subjects with Postherpetic Neuralgia

Conditions

Postherpetic Neuralgia

Keywords

Pain from Shingles, PHN, Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)

  Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated. This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF). The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)

  3 weeks

Secondary Outcomes (9)

• Change in Mean Daily Pain Score From Baseline to Week 1

  1 week

• Change in Mean Daily Pain Score From Baseline to Week 2

  2 week

• Change in Mean Daily Pain Score From Baseline to Week 3

  3 Weeks

• Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo

  3 Weeks

• Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment

  3 weeks

Study Arms (2)

XPF-002

EXPERIMENTAL

Drug: XPF-002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XPF-002 DRUG

Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient

XPF-002

Placebo DRUG

Twice daily application of Placebo ointment

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years (inclusive);
• Males or females of non-childbearing potential (ie, 12 months or more of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization);
• Male subjects with sexual partners of childbearing potential must agree to use contraception (abstinence, birth control pills, rings or patches, diaphragm and spermicide, intrauterine device, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implant or injection);
• Persistent pain for more than 6 months from the appearance of herpes zoster rash that is not located on the face, above the scalp hairline, or in proximity to mucous membranes;
• Diagnosis of PHN;
• Persistent neuropathic pain that involves at least 1 dermatome and covering no more than 400 cm2;
• Mean daily pain intensity score in the target area of greater than or equal to 4 on an 11-point Likert NRS for a minimum of 4 days during the single-blind, placebo run-in period;
• Subject agrees to take only the protocol-defined rescue medication as prescribed;
• Intact skin over the painful area to be treated; and
• Able and willing to provide informed consent and comply with study procedures.

You may not qualify if:

• Subject with systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study in the opinion of the investigator;
• Creatinine clearance less than 30 mL/min;
• Subject with known history of human immunodeficiency virus, hepatitis C, or hepatitis B;
• Malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years;
• Subject with history of serious mental illness or psychiatric illness such as dementia, depression, or schizophrenia, that will limit his/her ability to comply with study procedures;
• Subject who is unable to apply, or have a care giver apply, study ointment to the area of most painful skin segments, BID, once within 2 hours of waking and once in the evening after dinner;
• Subject with known sensitivity to topical products;
• Subject with active herpes zoster lesions or dermatitis;
• Other severe or chronic pain that may impair the self-assessment of the pain due to PHN;
• Treatment with local anesthetic in the last 2 weeks or nerve blocks within the last 30 days;
• Subject who is taking any opioid medications to treat his/her PHN pain and is unable to washout of these medications for the duration of the study;
• Subject who is taking any prohibited medication and is unable to washout of these treatments for the duration of the study;
• Subject who is taking more than 2 permitted concomitant medications for the treatment of PHN and is unable to washout of all but 2 of these treatments for the duration of the study;
• Subject who is taking any local prescription or non-prescription therapy (lidocaine patch, transcutaneous electrical nerve stimulation, etc.) and is unable to washout of these treatments for the duration of the study;
• Subject who has used Qutenza® patches in the 90 days prior to screening or has used other capsaicin preparations on a daily basis in the 90 days prior to screening;

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (24)

Unknown Facility

Jonesboro, Arkansas, United States

Location

Unknown Facility

Lomita, California, United States

Location

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Westlake Village, California, United States

Location

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Bradenton, Florida, United States

Location

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Naples, Florida, United States

Location

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New Port Richey, Florida, United States

Location

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Ocala, Florida, United States

Location

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Sunrise, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Lexington, Kentucky, United States

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Bay City, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Hartsdale, New York, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Sugar Land, Texas, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

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: Dr. Paul Goldberg, VP Clinical Development
• Organization: Xenon Pharmaceuticals Inc.

pgoldberg@xenon-pharma.com

604-484-3300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 6, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

US (24)