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A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN) (XEN402)

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XPF-002
Placebo
Sponsored by
Xenon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Pain from Shingles, PHN, Postherpetic Neuralgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

XPF-002

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Change in Mean Daily Pain Score From Baseline to Week 1
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 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed. 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.)
Change in Mean Daily Pain Score From Baseline to Week 2
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 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed. 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.)
Change in Mean Daily Pain Score From Baseline to Week 3
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'. Missing data were not imputed. 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.)
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
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.
Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment
Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)
Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed. This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)). The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)
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)
Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated. This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF). The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)

Full Information

First Posted
August 31, 2010
Last Updated
September 20, 2013
Sponsor
Xenon Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01195636
Brief Title
A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
Acronym
XEN402
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenon Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Pain from Shingles, PHN, Postherpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XPF-002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
XPF-002
Intervention Description
Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily application of Placebo ointment
Primary Outcome Measure Information:
Title
Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)
Description
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.)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in Mean Daily Pain Score From Baseline to Week 1
Description
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 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed. 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.)
Time Frame
1 week
Title
Change in Mean Daily Pain Score From Baseline to Week 2
Description
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 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed. 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.)
Time Frame
2 week
Title
Change in Mean Daily Pain Score From Baseline to Week 3
Description
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'. Missing data were not imputed. 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.)
Time Frame
3 Weeks
Title
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
Description
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.
Time Frame
3 Weeks
Title
Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
Time Frame
3 weeks
Title
Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
Time Frame
3 Weeks
Title
Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment
Time Frame
3 Weeks
Title
Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)
Description
Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed. This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)). The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)
Time Frame
3 Weeks
Title
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)
Description
Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated. This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF). The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)
Time Frame
3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Lomita
State/Province
California
Country
United States
City
Westlake Village
State/Province
California
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Sunrise
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Bay City
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Hartsdale
State/Province
New York
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
West Reading
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Sugar Land
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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