Inherited Erythromelalgia Clinical Trial
Official title:
Phase 2a, Exploratory, Double-blind, Placebo-controlled Two-part Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Topically Applied XPF-002 (XEN402 8% w/w Ointment) in Patients With Primary/Inherited Erythromelalgia
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.
Your role in the study would include:
- Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each
lasting approximately 1 day
- Travelling and staying in the clinic for 2 in-patient stays:
- For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic
- For the second in-patient visit you will have to spend 2 days and 1 night in the clinic
You can bring books, laptops and DVDs to the clinic.
If you do not live within driving distance to the clinic you will need to stay in the local
area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in
addition to the in-patient portion of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01769274 -
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
|
Phase 2 | |
| Completed |
NCT01090622 -
Study of XPF-001 in the Treatment of Pain From Primary/Inherited Erythromelalgia (IEM)
|
Phase 1/Phase 2 |