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CompletedNCT01195636XEN402Updated Nov 25, 2013Results posted

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

A Phase 2 interventional study of XPF-002 and Placebo in Postherpetic Neuralgia, sponsored by Xenon Pharmaceuticals Inc.. Completed at 24 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Xenon Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Postherpetic Neuralgia

Keywords

  • Pain from Shingles, PHN, Postherpetic Neuralgia
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 70 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Xenon Pharmaceuticals Inc. is the lead sponsor of 23 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    XPF-002

    Drug: XPF-002

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugXPF-002

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

  • DrugPlacebo

    Twice daily application of Placebo ointment

06

What researchers measure

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.)

    Time frame: 3 weeks

Secondary outcomes

  1. 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.)

    Time frame: 1 week

  2. 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.)

    Time frame: 2 week

  3. 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.)

    Time frame: 3 Weeks

  4. 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.

    Time frame: 3 Weeks

  5. 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

  6. 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

  7. Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment

    Time frame: 3 Weeks

  8. 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.)

    Time frame: 3 Weeks

  9. 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.)

    Time frame: 3 Weeks

07

Results

Posted Nov 25, 2013

Participant flow

First Intervention (3 Weeks)
Participant flow — First Intervention (3 Weeks)
MilestoneXPF-002 First, Then PlaceboPlacebo First, Then XPF-002
Started3535
Received at least 1 dose of drug3335
Completed3032
Not completed53
Withdrew: Adverse event23
Withdrew: Protocol violation10
Withdrew: Withdrawal by subject10
Withdrew: Lost to follow-up10
Washout Period (2 Weeks)
Participant flow — Washout Period (2 Weeks)
MilestoneXPF-002 First, Then PlaceboPlacebo First, Then XPF-002
Started3032
Completed2829
Not completed23
Withdrew: Adverse event11
Withdrew: Withdrawal by subject12
Second Intervention (3 Weeks)
Participant flow — Second Intervention (3 Weeks)
MilestoneXPF-002 First, Then PlaceboPlacebo First, Then XPF-002
Started2829
Completed2727
Not completed12
Withdrew: Adverse event11
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryChange 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.)

Time frame:
3 weeks
Reported as:
Least squares mean · units on a scale
Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)
units on a scaleXPF-002Placebo
Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)-0.94 (-1.30 to -0.58)-0.97 (-1.33 to -0.61)
SecondaryChange 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.)

Time frame:
1 week
Reported as:
Least squares mean · units on a scale
Change in Mean Daily Pain Score From Baseline to Week 1
units on a scaleXPF-002Placebo
Change in Mean Daily Pain Score From Baseline to Week 1-0.42 (-0.73 to -0.11)-0.55 (-0.86 to -0.24)
SecondaryChange 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.)

Time frame:
2 week
Reported as:
Least squares mean · units on a scale
Change in Mean Daily Pain Score From Baseline to Week 2
units on a scaleXPF-002Placebo
Change in Mean Daily Pain Score From Baseline to Week 2-0.74 (-1.07 to -0.41)-0.70 (-1.03 to -0.37)
SecondaryChange 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.)

Time frame:
3 Weeks
Reported as:
Least squares mean · units on a scale
Change in Mean Daily Pain Score From Baseline to Week 3
units on a scaleXPF-002Placebo
Change in Mean Daily Pain Score From Baseline to Week 3-0.96 (-1.33 to -0.58)-0.96 (-1.34 to -0.59)
SecondaryProportion 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.

Time frame:
3 Weeks
Reported as:
Number · participants
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
participantsXPF-002Placebo
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 Placebo2219
SecondaryProportion 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
Reported as:
Number · participants
Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
participantsXPF-002Placebo
Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment156
SecondaryProportion 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
Reported as:
Number · participants
Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment
participantsXPF-002Placebo
Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment2112
SecondaryProportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment
Time frame:
3 Weeks
Reported as:
Number · participants
Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment
participantsXPF-002Placebo
Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment3840
SecondaryChange 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.)

Time frame:
3 Weeks
Reported as:
Mean · units on a scale
Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)
units on a scaleXPF-002Placebo
Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)-6.7 ± 16.28-6.1 ± 13.51
SecondaryChange 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.)

Time frame:
3 Weeks
Reported as:
Least squares mean · units on a scale
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)
units on a scaleXPF-002Placebo
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)-0.81 (-1.21 to -0.41)-0.84 (-1.24 to -0.43)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
XPF-002—1/62 (1.6%)12/62 (19.4%)
Placebo—1/63 (1.6%)17/63 (27%)
Most frequent serious events
Most frequent serious events
EventXPF-002Placebo
Coronary artery diseaseCardiac disorders1/620/63
Tooth abcessInfections and infestations0/621/63
Most frequent other events
Most frequent other events
EventXPF-002Placebo
Application site painGeneral disorders2/6210/63
Application site pruritusGeneral disorders2/628/63
Application site exfoliationGeneral disorders3/625/63
Application site rashGeneral disorders4/623/63
Application site erythemaGeneral disorders4/621/63

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)XPF-002 First, Then PlaceboPlacebo First, Then XPF-002Total
<=18 years101
Between 18 and 65 years231841
>=65 years111728
Age Continuous
Age Continuous(years)XPF-002 First, Then PlaceboPlacebo First, Then XPF-002Total
Mean58.3 ± 13.5863.1 ± 9.7360.7 ± 11.98
Sex: Female, Male
Sex: Female, Male(Participants)XPF-002 First, Then PlaceboPlacebo First, Then XPF-002Total
Female201939
Male151631
Region of Enrollment
Region of Enrollment(participants)XPF-002 First, Then PlaceboPlacebo First, Then XPF-002Total
United States353570
08

Study locations

24 sites
  • Jonesboro, Arkansas, United States
  • Lomita, California, United States
  • Westlake Village, California, United States
  • Bradenton, Florida, United States
  • Naples, Florida, United States
  • New Port Richey, Florida, United States
  • Ocala, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Marietta, Georgia, United States
  • Lexington, Kentucky, United States
  • Bay City, Michigan, United States
  • St. Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Albuquerque, New Mexico, United States
  • Hartsdale, New York, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • West Reading, Pennsylvania, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • Sugar Land, Texas, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01195636
Lead sponsor
Xenon Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Sep 6, 2010
Start date
Aug 2010
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Nov 25, 2013
Last update
Nov 25, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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