Post-herpetic NeuralgiaPhase 2EMPHENENCT03094195
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
A Phase 2 study testing EMA401 in people with Post-herpetic Neuralgia, run by Novartis Pharmaceuticals at 58 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-herpetic Neuralgia
- What is being tested?
- EMA401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 58 sitesin 19 countries
- Study dates
- 27 Jun 2017to 7 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%.
Trial locations and contacts
58 sites in 19 countries.
58 sites in 19 countries
Japan10 sites
Novartis Investigative Site
Kasukabe-shi, Tokyo, 343-0012
Novartis Investigative Site
Kawaguchi, Saitama
Novartis Investigative Site
Nishinomiya, Hyōgo, 663 8014
Novartis Investigative Site
Ōita
Novartis Investigative Site
Sakai, Osaka, 593-8324
Novartis Investigative Site
Setagaya Ku, Tokyo, 154-0015
Novartis Investigative Site
Shizuoka, Shizuoka, 420-0839
Novartis Investigative Site
Yokohama, Kanagawa, 241-0022
Novartis Investigative Site
Yokohama, Kanagawa, 244-0816
Novartis Investigative Site
Yokohama, Kanagawa, 245-8575
Germany9 sites
Novartis Investigative Site
Berlin, 10435
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45147
Novartis Investigative Site
Haar, 85540
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Kiel, 24119
Novartis Investigative Site
Leipzig, 04109
Novartis Investigative Site
Wiesbaden, 65191
Portugal5 sites
Novartis Investigative Site
Almada, 2801 951
Novartis Investigative Site
Aveiro, 3814-501
Novartis Investigative Site
Leiria, 2410-187
Novartis Investigative Site
Lisbon, 1500 650
Novartis Investigative Site
Porto, 4099-001
Czechia4 sites
Novartis Investigative Site
Brno, 615 00
Novartis Investigative Site
Choceň, 56501
Novartis Investigative Site
Plzen-Bory, 305 99
Novartis Investigative Site
Prague, 100 00
France4 sites
Novartis Investigative Site
Boulogne-Billancourt, 92104
Novartis Investigative Site
Clermont-Ferrand, 63000
Novartis Investigative Site
Lille Cédex, 59037
Novartis Investigative Site
Nice, 06003
Slovakia4 sites
Novartis Investigative Site
Banská Bystrica, 974 04
Novartis Investigative Site
Dubnica nad Váhom, SVK, 018 41
Novartis Investigative Site
Prešov, 08001
Novartis Investigative Site
Spišská Nová Ves, 05201
Canada3 sites
Novartis Investigative Site
Lévis, Quebec, G6W 5M6
Novartis Investigative Site
Ontario, CAN, L4J 1W3
Novartis Investigative Site
Québec, Quebec, G3K 2P8
Hungary3 sites
Novartis Investigative Site
Esztergom, HUN, 2500
Novartis Investigative Site
Kistarcsa, 2143
Novartis Investigative Site
Szeged, 6725
United Kingdom3 sites
Novartis Investigative Site
Darlington, Durham, DL3 6HX
Novartis Investigative Site
Liverpool, L9 7LJ
Novartis Investigative Site
London, GBR, SW10 9NH
Austria2 sites
Novartis Investigative Site
Klagenfurt, 9020
Novartis Investigative Site
Vienna, A-1160
Poland2 sites
Novartis Investigative Site
Olsztyn, 10 561
Novartis Investigative Site
Warsaw, 00 144
Spain2 sites
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
South Korea1 site
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712
About this study
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
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).
Read the 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.
- Conditions
- Post-herpetic Neuralgia
- Being tested
- EMA401, Placebo
- Keywords
- post-herpetic neuralgia, neuropathic pain, angiotensin II type 2 receptor antagonist, dose ranging
- Medical subject headings
- Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA401Drug
EMA401
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| EMA401 25mg BID | Experimental | Ema401 25 mg was administered orally twice a day Receives: Drug: EMA401 |
| EMA401 100mg BID | Experimental | Ema401 100 mg was administered orally twice a day Receives: Drug: EMA401 |
| Placebo BID | Placebo comparator | Matching placebo capsules administered orally twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 12
Secondary outcomes (11)
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.
Measured: Baseline up to Week 12
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
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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
Measured: Week 8, Week 12
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
Measured: Baseline, Week 8, Week 12
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
Measured: Approximately from 3 weeks after end of study up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start27 Jun 2017
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Why it stopped: The study was terminated early due to pre-clinical toxicity data that became available after start of trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094195
- Sponsor's protocol ID
- CEMA401A2201
- Acronym
- EMPHENE
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2017
- Last updated
- 8 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 33675631
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03094195
- Acronym / sponsor ID
- EMPHENE / CEMA401A2201
- Conditions
- Post-herpetic Neuralgia
- Keywords
- post-herpetic neuralgia, neuropathic pain, angiotensin II type 2 receptor antagonist, dose ranging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to pre-clinical toxicity data that became available after start of trial
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 14 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMA401 25mg BID | Experimental | Drug: EMA401Ema401 25 mg was administered orally twice a day |
| EMA401 100mg BID | Experimental | Drug: EMA401Ema401 100 mg was administered orally twice a day |
| Placebo BID | Placebo comparator | Drug: PlaceboMatching placebo capsules administered orally twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMA401EMA401 | Drug | EMA401 100mg BID, EMA401 25mg BID |
| PlaceboPlacebo | Drug | Placebo BID |
Primary outcome
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
Time frame: Baseline up 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.
11 secondary outcomes
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Time frame: Baseline up to Week 12
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12
Time frame: Baseline up to Week 12
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12
Time frame: Baseline up to Week 12
Number of Participants Per Patient Global Impression of Change Category at Week 12
Time frame: Baseline up to Week 12
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Time frame: Baseline up to Week 12
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale
Time frame: Baseline up to Week 12
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12
Time frame: Baseline up to Week 12
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
Time frame: Baseline up to Week 12
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Time frame: Week 8, Week 12
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)
Time frame: Baseline, Week 8, Week 12
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Time frame: Approximately from 3 weeks after end of study up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33675631Rice 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.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
58 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMA401 in people with Post-herpetic Neuralgia, run by Novartis Pharmaceuticals at 58 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Japan, Germany, Portugal, Czechia, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.