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

NCT03094195 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CEMA401A2201
• Study Type: interventional
• Target: 130
• Locations: 18 countries
• Sites: 57

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).

Conditions

Post-herpetic Neuralgia

Keywords

post-herpetic neuralgia; neuropathic pain; angiotensin II type 2 receptor antagonist; dose ranging

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline up to Week 12

• Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12

  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

  Baseline up to Week 12

• Number of Participants Per Patient Global Impression of Change Category at Week 12

  Baseline up to Week 12

• Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale

  Baseline up to Week 12

Study Arms (3)

EMA401 25mg BID

EXPERIMENTAL

Ema401 25 mg was administered orally twice a day

Drug: EMA401

EMA401 100mg BID

EXPERIMENTAL

Ema401 100 mg was administered orally twice a day

Drug: EMA401

Placebo BID

PLACEBO COMPARATOR

Matching placebo capsules administered orally twice a day

Drug: Placebo

Interventions

EMA401 DRUG

EMA401

EMA401 100mg BID; EMA401 25mg BID

Placebo DRUG

Placebo

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Klagenfurt, 9020, Austria

Location

Novartis Investigative Site

Vienna, A-1160, Austria

Location

Novartis Investigative Site

Pellenberg, 3212, Belgium

Location

Novartis Investigative Site

Ontario, CAN, L4J 1W3, Canada

Location

Novartis Investigative Site

Lévis, Quebec, G6W 5M6, Canada

Location

Novartis Investigative Site

Québec, Quebec, G3K 2P8, Canada

Location

Novartis Investigative Site

Brno, 615 00, Czechia

Location

Novartis Investigative Site

Choceň, 56501, Czechia

Location

Novartis Investigative Site

Plzen-Bory, 305 99, Czechia

Location

Novartis Investigative Site

Prague, 100 00, Czechia

Location

Novartis Investigative Site

Odense C, DK 5000, Denmark

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Novartis Investigative Site

Boulogne-Billancourt, 92104, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63000, France

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Novartis Investigative Site

Lille Cédex, 59037, France

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Novartis Investigative Site

Nice, 06003, France

Location

Novartis Investigative Site

Essen, North Rhine-Westphalia, 45147, Germany

Location

Novartis Investigative Site

Berlin, 10435, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Haar, 85540, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Kiel, 24119, Germany

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Novartis Investigative Site

Leipzig, 04109, Germany

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Novartis Investigative Site

Wiesbaden, 65191, Germany

Location

Novartis Investigative Site

Esztergom, HUN, 2500, Hungary

Location

Novartis Investigative Site

Kistarcsa, 2143, Hungary

Location

Novartis Investigative Site

Szeged, 6725, Hungary

Location

Novartis Investigative Site

Rome, 00185, Italy

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 663 8014, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 241-0022, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 244-0816, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 245-8575, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 593-8324, Japan

Location

Novartis Investigative Site

Kawaguchi, Saitama, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 420-0839, Japan

Location

Novartis Investigative Site

Kasukabe-shi, Tokyo, 343-0012, Japan

Location

Novartis Investigative Site

Setagaya Ku, Tokyo, 154-0015, Japan

Location

Novartis Investigative Site

Ōita, Japan

Location

Novartis Investigative Site

Oslo, 0450, Norway

Location

Novartis Investigative Site

Olsztyn, 10 561, Poland

Location

Novartis Investigative Site

Warsaw, 00 144, Poland

Location

Novartis Investigative Site

Almada, 2801 951, Portugal

Location

Novartis Investigative Site

Aveiro, 3814-501, Portugal

Location

Novartis Investigative Site

Leiria, 2410-187, Portugal

Location

Novartis Investigative Site

Lisbon, 1500 650, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Dubnica nad Váhom, SVK, 018 41, Slovakia

Location

Novartis Investigative Site

Banská Bystrica, 974 04, Slovakia

Location

Novartis Investigative Site

Prešov, 08001, Slovakia

Location

Novartis Investigative Site

Spišská Nová Ves, 05201, Slovakia

Location

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, 463-712, South Korea

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Barcelona, 08025, Spain

Location

Novartis Investigative Site

Tainan, 70403, Taiwan

Location

Novartis Investigative Site

Darlington, Durham, DL3 6HX, United Kingdom

Location

Novartis Investigative Site

London, GBR, SW10 9NH, United Kingdom

Location

Novartis Investigative Site

Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33675631 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia

Interventions

EMA400

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

888-669-6682

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: June 27, 2017
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: October 8, 2021
• Results First Posted: May 14, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); CA (3); CZ (4); SL (4); KR (1); ES (2); GB (3); DK (1); NO (1); PT (5); BE (1); FR (4); JP (10); PL (2); HU (3); IT (1); TW (1); DE (9)