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Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN) (EMPHENE)

Primary Purpose

Post-herpetic Neuralgia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EMA401
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-herpetic Neuralgia focused on measuring post-herpetic neuralgia, neuropathic pain, angiotensin II type 2 receptor antagonist, dose ranging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At the time of Screening, must have had documented diagnosis of PHN (ICD-10 code B02.29), defined as pain in the region of the rash persisting for more than 6 months after onset of herpes zoster rash.
  • Assessed as suffering from moderate to severe neuropathic pain across the Screening epoch (NRS ≥ 4).
  • Patients must have had documented past and/or ongoing inadequate treatment response (having insufficient pain relief with treatment or inability to tolerate) to at least 2 different prescribed therapies commonly used to treat and considered effective by the Investigator for the treatment of PHN.
  • Patient must have been willing to complete daily eDiary

Exclusion Criteria:

  • History or had current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
  • Had a major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Had evidence of significant renal insufficiency or pre-existing liver condition
  • Had platelets ≤ 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men.
  • Patients who had a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who did not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EMA401 25mg BID

EMA401 100mg BID

Placebo BID

Arm Description

Ema401 25 mg was administered orally twice a day

Ema401 100 mg was administered orally twice a day

Matching placebo capsules administered orally twice a day

Outcomes

Primary Outcome Measures

Dose-response in Change in Weekly Mean of the 24-hour Average Pain Score, Using an 11-point Numeric Rating Scale (NRS), From Baseline to Week 12
Since the 300 mg b.i.d. dose of EMA401 could not be initiated in the study due to premature study termination, the dose-response characterization was not performed. Specifically, only the trend test deduced from the set of candidate models was performed but the dose response estimation was not conducted.

Secondary Outcome Measures

Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12
The BPI-SF is a validated, self-administered (at clinic) questionnaire that assesses pain severity and its mpact on daily functions. Patients were asked to complete the 7-item pain interference scale that assessed the degree to which pain interfered with walking and other physical activity, work, mood, relations with others and sleep using a zero to ten numeric rating scale (NRS) with zero being "does not interfere" and ten being "completely interferes". A reduction in mean indicates improvement
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Number of Participants Per Patient Global Impression of Change Category at Week 12
The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. The PGIC was to be completed by patients using the electronic tablet at the site
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 30% /50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio >1 = higher chance of a clinically important improvement.
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio >1 = higher chance of a clinically important improvement.
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12
Patients were asked to complete the ISI using five-point Likert-style scale as a measure of perceived sleep difficulties. Scores ranged from zero to 28, with a cut-off score of eight suggesting the presence of sub-threshold insomnia. The questionnaire assessed the severity of insomnia, satisfaction with current sleep pattern, sleep interference, "noticeability" of sleeping problem to others and concern about sleeping problems.
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
The Neuropathic Pain Symptom Inventory (NPSI) is a 12 item patient reported outcome measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain and paraesthesia/dysesthesia) and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The sum of the responses to the 10 questions (all except temporal questions) was regarded as the total score and was divided by 10 (10 questions). The range of the total score and of the 5 dimensional scores is 0 to 10. Lower values represent better outcomes.
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Due to the premature termination of the study, the number of patients and observations providing PK data was much smaller than planned, and no PK model was developed. As a consequence, no PK parameters (Cmax, Tmax, AUC) were derived for this study. Only, summary statistics of the plasma concentrations were calculated
Exposure-response (Decrease in Pain Intensity) Via Evaluation of Effect of EMA401 Exposure on Efficacy Variables (e.g. Change From Baseline of Pain Score), Via Descriptive Pharmacokinetics/ Pharmacodynamics (PK/PD)
Due to the premature termination of the study, the number of patients providing data for PKPD analysis data was much smaller than planned and no model to correlate drug exposure (PK) with the change in the pain score (PD) was developed
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Participants were instructed to stop taking drug immediately upon termination of study and asked to come in for two unscheduled visits for follow up safety assessments

Full Information

First Posted
March 23, 2017
Last Updated
October 7, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03094195
Brief Title
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
Acronym
EMPHENE
Official Title
A Double-blind, Placebo-controlled, Randomized Dose Ranging Trial to Determine the Safety and Efficacy of Three Dose Levels of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Post-herpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to pre-clinical toxicity data that became available after start of trial
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).
Detailed Description
This was an interventional, randomized, parallel, placebo-controlled, dose ranging, double-blind treatment study consisting of 3 periods i.e. Screening, Treatment, and Treatment withdrawal. The study was planned in two cohorts. The initial cohort had three treatment arms i.e. Placebo b.i.d., EMA401 25 mg b.i.d., or EMA401 100 mg b.i.d. Following an unblinded safety review by an independent DMC, the second cohort was to have been initiated with an additional treatment arm i.e. EMA401 300 mg b.i.d.. Due to the premature study termination, the second cohort was not initiated. At the end of treatment period the 25mg BID and 100mg BID arms were re-randomized (1:1) to the same treatment or placebo. Placebo arm stayed on placebo. The planned duration of treatment period was 12 weeks and 1 week of treatment withdrawal at the end of treatment period. The study was terminated early due to pre-clinical toxicity data that became available after start of trial. Novartis implemented a Urgent Safety Measure (USM) which instructed sites to discontinue study treatment immediately and to have all patients return for additional laboratory assessments (full hematology including coagulation and clinical chemistry panel). Safety data from the USM was presented as a separate outcome measure table and not included in the Adverse Event section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-herpetic Neuralgia
Keywords
post-herpetic neuralgia, neuropathic pain, angiotensin II type 2 receptor antagonist, dose ranging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMA401 25mg BID
Arm Type
Experimental
Arm Description
Ema401 25 mg was administered orally twice a day
Arm Title
EMA401 100mg BID
Arm Type
Experimental
Arm Description
Ema401 100 mg was administered orally twice a day
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules administered orally twice a day
Intervention Type
Drug
Intervention Name(s)
EMA401
Intervention Description
EMA401
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Dose-response in Change in Weekly Mean of the 24-hour Average Pain Score, Using an 11-point Numeric Rating Scale (NRS), From Baseline to Week 12
Description
Since the 300 mg b.i.d. dose of EMA401 could not be initiated in the study due to premature study termination, the dose-response characterization was not performed. Specifically, only the trend test deduced from the set of candidate models was performed but the dose response estimation was not conducted.
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Description
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Time Frame
Baseline up to Week 12
Title
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12
Description
The BPI-SF is a validated, self-administered (at clinic) questionnaire that assesses pain severity and its mpact on daily functions. Patients were asked to complete the 7-item pain interference scale that assessed the degree to which pain interfered with walking and other physical activity, work, mood, relations with others and sleep using a zero to ten numeric rating scale (NRS) with zero being "does not interfere" and ten being "completely interferes". A reduction in mean indicates improvement
Time Frame
Baseline up to Week 12
Title
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12
Description
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Time Frame
Baseline up to Week 12
Title
Number of Participants Per Patient Global Impression of Change Category at Week 12
Description
The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. The PGIC was to be completed by patients using the electronic tablet at the site
Time Frame
Baseline up to Week 12
Title
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Description
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 30% /50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio >1 = higher chance of a clinically important improvement.
Time Frame
Baseline up to Week 12
Title
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale
Description
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio >1 = higher chance of a clinically important improvement.
Time Frame
Baseline up to Week 12
Title
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12
Description
Patients were asked to complete the ISI using five-point Likert-style scale as a measure of perceived sleep difficulties. Scores ranged from zero to 28, with a cut-off score of eight suggesting the presence of sub-threshold insomnia. The questionnaire assessed the severity of insomnia, satisfaction with current sleep pattern, sleep interference, "noticeability" of sleeping problem to others and concern about sleeping problems.
Time Frame
Baseline up to Week 12
Title
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
Description
The Neuropathic Pain Symptom Inventory (NPSI) is a 12 item patient reported outcome measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain and paraesthesia/dysesthesia) and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The sum of the responses to the 10 questions (all except temporal questions) was regarded as the total score and was divided by 10 (10 questions). The range of the total score and of the 5 dimensional scores is 0 to 10. Lower values represent better outcomes.
Time Frame
Baseline up to Week 12
Title
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Description
Due to the premature termination of the study, the number of patients and observations providing PK data was much smaller than planned, and no PK model was developed. As a consequence, no PK parameters (Cmax, Tmax, AUC) were derived for this study. Only, summary statistics of the plasma concentrations were calculated
Time Frame
Week 8, Week 12
Title
Exposure-response (Decrease in Pain Intensity) Via Evaluation of Effect of EMA401 Exposure on Efficacy Variables (e.g. Change From Baseline of Pain Score), Via Descriptive Pharmacokinetics/ Pharmacodynamics (PK/PD)
Description
Due to the premature termination of the study, the number of patients providing data for PKPD analysis data was much smaller than planned and no model to correlate drug exposure (PK) with the change in the pain score (PD) was developed
Time Frame
Baseline, Week 8, Week 12
Title
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Description
Participants were instructed to stop taking drug immediately upon termination of study and asked to come in for two unscheduled visits for follow up safety assessments
Time Frame
Approximately from 3 weeks after end of study up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At the time of Screening, must have had documented diagnosis of PHN (ICD-10 code B02.29), defined as pain in the region of the rash persisting for more than 6 months after onset of herpes zoster rash. Assessed as suffering from moderate to severe neuropathic pain across the Screening epoch (NRS ≥ 4). Patients must have had documented past and/or ongoing inadequate treatment response (having insufficient pain relief with treatment or inability to tolerate) to at least 2 different prescribed therapies commonly used to treat and considered effective by the Investigator for the treatment of PHN. Patient must have been willing to complete daily eDiary Exclusion Criteria: History or had current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study Had a major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. Had evidence of significant renal insufficiency or pre-existing liver condition Had platelets ≤ 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent), hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men. Patients who had a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who did not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Novartis Investigative Site
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A-1160
Country
Austria
Facility Name
Novartis Investigative Site
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
Facility Name
Novartis Investigative Site
City
Ontario
State/Province
CAN
ZIP/Postal Code
L4J 1W3
Country
Canada
Facility Name
Novartis Investigative Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Novartis Investigative Site
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Odense C
ZIP/Postal Code
DK 5000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Novartis Investigative Site
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Novartis Investigative Site
City
LILLE Cédex
ZIP/Postal Code
59037
Country
France
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Name
Novartis Investigative Site
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Haar
ZIP/Postal Code
85540
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24119
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Novartis Investigative Site
City
Esztergom
State/Province
HUN
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Rome
ZIP/Postal Code
00185
Country
Italy
Facility Name
Novartis Investigative Site
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663 8014
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-0022
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
244-0816
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawaguchi-city
State/Province
Saitama
Country
Japan
Facility Name
Novartis Investigative Site
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0839
Country
Japan
Facility Name
Novartis Investigative Site
City
Kasukabe-shi
State/Province
Tokyo
ZIP/Postal Code
343-0012
Country
Japan
Facility Name
Novartis Investigative Site
City
Setagaya ku
State/Province
Tokyo
ZIP/Postal Code
154-0015
Country
Japan
Facility Name
Novartis Investigative Site
City
Oita
Country
Japan
Facility Name
Novartis Investigative Site
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10 561
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
00 144
Country
Poland
Facility Name
Novartis Investigative Site
City
Almada
ZIP/Postal Code
2801 951
Country
Portugal
Facility Name
Novartis Investigative Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Novartis Investigative Site
City
Leiria
ZIP/Postal Code
2410-187
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1500 650
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Dubnica nad Vahom
State/Province
SVK
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Presov
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Novartis Investigative Site
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Darlington
State/Province
Durham
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
State/Province
GBR
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
33675631
Citation
Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=623
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)

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