Clinical trial NCT01195636: A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Systemic Exposure of Topical XPF-002 in Subjects With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Pain from Shingles, PHN, Postherpetic Neuralgia
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Subject who has participated in more than 1 other topical study for pain and more than 3 other PHN clinical studies;
* Pregnant or lactating females;
* Subject who has an active history of alcohol or drug abuse;
* Subject who has participated in any other investigational study within 60 days prior to screening;
* Subject who is employed by the Sponsor, study staff, and their families; or
* Subject who has any condition that would make him/her, in the opinion of the investigator or Sponsor, unsuitable for the study.

Primary outcomes:
measure: Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in Mean Daily Pain Score From Baseline to Week 1
timeFrame: 1 week
measure: Change in Mean Daily Pain Score From Baseline to Week 2
timeFrame: 2 week
measure: Change in Mean Daily Pain Score From Baseline to Week 3
timeFrame: 3 Weeks
measure: 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
timeFrame: 3 Weeks
measure: Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
timeFrame: 3 weeks
measure: Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
timeFrame: 3 Weeks
measure: Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment
timeFrame: 3 Weeks
measure: Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)
timeFrame: 3 Weeks
measure: Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF)
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Lomita
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Bay City
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Hartsdale
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
Study officials:
References: