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Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426411
Recruitment Status : Withdrawn
First Posted : April 24, 2015
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Spinifex Pharmaceuticals Pty Ltd

Brief Summary:
The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with postherpetic neuralgia.

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: EMA401 200 mg Drug: EMA401 600 mg Drug: Placebo Phase 2

Detailed Description:

Screening Period (Up to Four Weeks) to confirm eligibility for the study which will be determined by Screening tests, physical examination/medical history and fulfillment of eligibility criteria including assessment of pain.

Study Period (14 Weeks) Approximately 360 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, 300 mg BID 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: EMA401 200 mg
2 X 50 mg capsules BID
Drug: EMA401 200 mg
Experimental: EMA401 600 mg
2 X 150 mg capsules BID
Drug: EMA401 600 mg
Placebo Comparator: Placebo
Placebo to match 2 capsules BID
Drug: Placebo



Primary Outcome Measures :
  1. To determine the efficacy of two dose levels of EMA401 compared to placebo in patients with postherpetic neuralgia (PHN), as assessed by the change in the weekly mean of the 24 hour average pain score using an 11-point Numerical Rating Scale (NRS) [ Time Frame: Baseline to approximately Week 14 ]

Secondary Outcome Measures :
  1. To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score [ Time Frame: Baseline to approximately Week 14 ]
  2. To evaluate the effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score [ Time Frame: Baseline to approximately Week 14 ]
  3. To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to approximately Week 14 ]
  4. To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain [ Time Frame: Baseline to approximately Week 14 ]
  5. To determine the proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean pain of the 24 hour average score (NRS) compared to placebo (i.e., responder rates) [ Time Frame: Baseline to approximately Week 14 ]
  6. To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI) [ Time Frame: Baseline to approximately Week 14 ]
  7. To evaluate the safety and tolerability of EMA401 in patients with PHN as measured by adverse events, vital signs, and laboratory results [ Time Frame: Baseline to approximately Week 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be diagnosed as suffering from PHN defined as pain in the region of the rash persisting for more than six months after onset of herpes zoster rash.
  • Be assessed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex. The Investigator/site staff will be informed immediately as to whether the patient is eligible or ineligible on the ePRO website based on the patient entering all relevant pain scores in the eDiary device.
  • Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit (Visit 1) and within 72 hours prior to administration of IP.

Exclusion Criteria:

  • Patients taking any topical treatment for their PHN at the time of Screening Visit 2 will be excluded, including lidocaine plaster, capsaicin patch, and any other topical preparations of these or any other topical medications (e.g., aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) for their PHN.
  • Have a blood pressure reading, after resting for at least five minutes, outside a systolic blood pressure range of 84-151 mmHg or a diastolic blood pressure > 95 mmHg. If the blood pressure is outside of the range, a repeat measurement can be taken after the patient has rested. The repeat measurement should be used as the screening value.
  • Have serum aspartate transaminase (AST) or alanine transaminase (ALT) levels > 1.5 x the upper limit of normal or have total bilirubin concentrations > 1.5 x the upper limit of normal at Screening (Visit 1).
  • Patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.
  • Have active herpes zoster upon physical examination at Screening (Visit 1) or during the study.
  • Known history of, or positive laboratory result for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen (HBsAg), HCV antibodies or HIV antibodies respectively.
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Responsible Party: Spinifex Pharmaceuticals Pty Ltd
ClinicalTrials.gov Identifier: NCT02426411    
Other Study ID Numbers: EMA401-006
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms