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XPF-002

Phase 2

Postherpetic Neuralgia | Small molecule | Pain |Xenon Pharmaceuticals Inc.|Last Updated: Apr 14, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

XPF-002 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT01195636A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)Postherpetic Neuralgia
COMPLETED70 Analytics
PHASE2COMPLETED
A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
Postherpetic NeuralgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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.)

Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2
14-21 Days

Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2. A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XPF-002EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
XPF-002DRUGTwice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient
PlaceboDRUGTwice daily application of Placebo ointment
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites24

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...

Countries:United States
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Frequently asked questions about XPF-002

What is XPF-002 used for?

XPF-002 is an investigational small molecule being developed by Xenon Pharmaceuticals Inc. (XENE) for the treatment of pain conditions, specifically Primary Erythromelalgia and Postherpetic Neuralgia. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does XPF-002 target?

XPF-002 is a small molecule being studied for pain indications, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its efficacy in treating Primary Erythromelalgia and Postherpetic Neuralgia, both of which are neuropathic pain conditions.

Who makes XPF-002?

XPF-002 is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XENE. The company is conducting clinical trials to evaluate the safety and efficacy of XPF-002 for pain-related indications.

What phase is XPF-002 in?

XPF-002 is in Phase 2 clinical development. It has completed one Phase 2 trial in Postherpetic Neuralgia and one Phase 1/2a exploratory study in Primary Erythromelalgia. The drug is investigational and has not received FDA approval.

What clinical trials is XPF-002 in?

XPF-002 has been studied in two completed clinical trials. NCT01195636 was a Phase 2 crossover study in 70 patients with Postherpetic Neuralgia. NCT01486446 was a Phase 2a exploratory study in 8 patients with Primary or Inherited Erythromelalgia. Both trials were conducted in the United States.

Is XPF-002 the same as any other drug?

No alternative names for XPF-002 have been reported. The drug is identified solely by its development code XPF-002 and is being investigated by Xenon Pharmaceuticals for pain indications including Primary Erythromelalgia and Postherpetic Neuralgia.