A postherpetic neuralgia study about safety and efficacy of EMA401
Research type
Research Study
Full title
A double-blind, placebo-controlled, randomized dose ranging trial to determine the safety and efficacy of two dose levels of EMA401 in patients with postherpetic neuralgia
IRAS ID
181177
Contact name
Andrew Rice
Contact email
Sponsor organisation
Spinifex Pharmaceuticals Pty Ltd
Eudract number
2015-000808-25
Clinicaltrials.gov Identifier
78,625, IND
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
This is a study to learn more about the safety and tolerability of EMA401 (active study drug) and its effectiveness, compared to placebo. EMA401 is a small molecule that has been shown to treat neuropathic pain in animal tests. Researchers know the effectiveness or EMA401 in animals and the postherpetic neuralgia (PHN) patients, however, it is not known how it works in human and how much of EMA401 is needed to treat the patients. This study will inform the selection of EMA401 doses for future Phase 2/3 clinical trials.
This study will be conducted at approximately 60 sites throughout the world; approximately 360 patients with postherpetic neuralgia (PHN), who are at least 18 years old, will be enrolled.
The study duration will be 4 months and 6 days and includes the following Study Periods:
• Screening Period (Visits 1 and 2) – Up to 4 weeks (28 days) for washout of non-permitted medications
• Treatment Period (Visits 3 – 11 which is Baseline – 14/End of Study)Eligibility for the study will be determined by Screening tests, physical examination/medical history and fulfilment of eligibility criteria including assessment of pain. Patients should be washed off any prohibited concomitant medications. Potential participants will be required to provide written informed consent prior to any study-specific Screening procedures being performed.
Following Screening assessments eligible male and female patients will receive double-blind treatment for 14 weeks. Patients will be randomized in a 1:1:1 ratio to treatment with EMA401 100 mg BID [Twice daily (bis in die)], 300 mg BID [Twice daily (bis in die)] or placebo.
Patients will attend the study site at the end of the Baseline visit and end of Weeks 1, 3, 5, 7, 9, 11, 13, and 14 for on-study assessments. During the Treatment Period, investigational product (IP; EMA401 or placebo) will be self-administered at home by the patient.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0293
Date of REC Opinion
27 Jul 2015
REC opinion
Unfavourable Opinion