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Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

Primary Purpose

Small Fiber Neuropathy, Diabetes Mellitus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BIIB074

Placebo

About this trial

This is an interventional treatment trial for Small Fiber Neuropathy

Eligibility Criteria

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

Key Inclusion Criteria:

This study will be conducted in subjects who have had a diagnosis of at least probable SFN, length-dependent distribution, for 6 months and ≤10 years prior to screening, defined as a history of the symptoms and clinical signs based on discussions at the ACTTION CONCEPPT meeting on diagnosis of SFN, Washington, DC March 2018, and confirmed by intraepidermal nerve fiber density (IENFD) values, and weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days of prior to the Screening visit.
In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 [moderate non-proliferative diabetic retinopathy]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease or current class IV heart failure to be eligible for the study.

Key Exclusion Criteria:

Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802).
Use of capsaicin patch within 3 months prior to Screening.
Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1.
Unable or unwilling to comply with the prohibited concomitant medication restrictions, including but not limited to UDP-glucuronosyltransferase (UGT) inducers and inhibitors, monoamine oxidase inhibitors (MAOIs), and Nav blockers.
Use of over-the-counter medications, vitamin and mineral supplements, herbal remedies (including St. John's wort), dietary supplements, or foods (including grapefruit juice) that affect and UGTs.
Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic index, including but not limited to digoxin.
History of hemophilia or Von Willebrand's disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy.
Any contraindication, as determined by the Investigator, to performing a skin biopsy for intraepidermal nerve fiber analysis.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Research Site
UMHAT 'Dr Georgi Stranski' EAD
Research Site
Research Site
Vancouver General Hospital
Toronto General Hospital
Research Site
Research Site
Recherche Médicale St-Jérôme Inc.
Research Site
Research Site
Fakultni Nemocnice Brno
Fakultni Nemocnice u sv. Anny v Brne
Research Site
Fakultni nemocnice Ostrava
Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice
Fakultni nemocnice v Motole
Research Site
Research Site
Research Site
OUH
Research Site
CHU Saint Etienne - Hôpital Nord
Hopital Salengro - CHRU de Lille
CHU Clermond Ferrand - Hopital Gabriel Montpied
Research Site
Hôpital Ambroise Paré - Boulogne-Billancourt
Research Site
Hopital Henri Mondor
Research Site
Groupement Hospitalier Sud - Hôpital Bicêtre
CHU Nice - Hôpital de l'Archet 1
Hopital Lariboisiere
Clinical Research
Research Site
Research Site
Clinical Research
Clinical Research
Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch
Hausarzt- und Diabetologische Schwerpunktpraxis
Zentrum fur Klinische Forschung
Gemeinschaftspraxis für Neurologie
Research Site
Diabetologische Schwerpunktpraxis Harburg
Research Site
DKD Helios Klinik Wiesbaden
Research Site
Research Site
Research Site
Research Site
AHEPA General Hospital of Thessaloniki
Research Site
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
UNO Medical Trials Kft.
Somogy Megyei Kaposi Mor Oktato Korhaz
Research Site
Research Site
Research Site
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Research Site
Research Site
Azienda Ospedaliero Univeraitaria Pisana
Università Campus Bio-Medico di Roma
Research Site
Amsterdam UMC, Locatie AMC
Maastricht UMC+
Research Site
Research Site
PRATIA MCM Kraków
Research Site
Research Site
Praktyka Lekarska Ewa Krzyzagorska
Research Site
Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska
Hospital General Universitario de Alicante
Hospital Universitari de Bellvitge
Research Site
Hospital Universitario Reina Sofia
Research Site
Research Site
Hospital Universitario Puerta de Hierro Majadahonda
Hospital Universitari i Politecnic La Fe
CHUV - Centre Hospitalier Universitaire Vaudois
Ospedale Regionale di Lugano
Kantonspital St. Gallen
Research Site
Royal Hallamshire Hospital
Clinical Reseach
Research Site
Research Site
Guy's Hospital
King's College Hospital
St Pancras Clinical Research
The Royal London Hospital
Research Site
John Radcliffe Hospital
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

BIIB074 350 mg

BIIB074 200 mg

Placebo

Arm Description

Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 350 mg tablets orally BID Double-Blind Treatment Period.

Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 200 mg tablets orally BID Double-Blind Treatment Period.

Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 placebo-matching tablets orally BID Double-Blind Treatment Period.

Outcomes

Primary Outcome Measures

Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score

Participants will rate their ADP using an 11-point Numerical Rating Scale (NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.

Change from Randomization in Weekly Mean ADP Score

Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean ADP scores for Randomization (the 7 days prior to the first dose of study treatment in the double-blind period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.

Secondary Outcome Measures

Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score

Participants will rate their WDP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean WDP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the WDP scores and calculated as the mean of the daily scores over the last 7 days.

Change from Baseline in Weekly Mean Sleep Interference Numerical Rating Scale (S-NRS)

Participants will rate their S-NRS using an 11-point NRS (0=pain does not interfere with sleep and 10= pain completely interferes with sleep) and record their score in an eDiary. Weekly mean S-NRS scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the daily S-NRS scores and calculated as the mean of the daily scores over the last 7 days.

Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score

Participant will use the NPSI questionnaire to rate different symptoms of neuropathic pain. The NPSI includes ten items related to different pain descriptors (e.g. burning and pressure) that are rated on an 11-point NRS (0=no symptoms to 10=worst symptoms imaginable). A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire.

Proportion of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP

Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.

Proportion of Participants with at least a 30% Reduction from Baseline in Weekly Mean ADP

Participants will rate their ADP using an 11-point NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.

Mean Weekly Amount of Rescue Medication

Use of rescue medication (paracetamol/acetaminophen) will be monitored and dosage will be recorded on a daily basis by the participant using an electronic Diary (eDiary). Mean weekly amount of rescue medication used for neuropathic pain during the double-blind period.

Patient Global Impression of Change (PGIC)

PGIC is a 7-point self-administered scale that depicts changes in a participant's overall status. Participants will rate their change as "1=very much improved," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse."

Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score

The BPI-SF is a 7-item self-administered questionnaire that measures how much pain has interfered with daily functioning. Participants will rate the level of pain interference on daily functioning on an 11-point NRS where 0=does not interfere and 10=completely interferes.

Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double-Blind Period

AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Area Under the Concentration-time Curve at Steady State

Maximum Observed Concentration (Cmax) at Steady State

Full Information

NCT ID

NCT03339336

First Posted

November 8, 2017

Last Updated

April 30, 2021

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT03339336

Brief Title

Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

Official Title

A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to close study early; not due to safety concerns

Study Start Date

May 31, 2018 (Actual)

Primary Completion Date

April 12, 2021 (Actual)

Study Completion Date

April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score. The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Fiber Neuropathy, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB074 350 mg

Arm Type

Experimental

Arm Description

Arm Title

BIIB074 200 mg

Arm Type

Experimental

Arm Description

Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 200 mg tablets orally BID Double-Blind Treatment Period.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 placebo-matching tablets orally BID Double-Blind Treatment Period.

Intervention Type

Drug

Intervention Name(s)

BIIB074

Intervention Description

Administered as specified in the treatment arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered as specified in the treatment arm.

Primary Outcome Measure Information:

Title

Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score

Description

Time Frame

Baseline and Week 12 of the Double-Blind Period

Title

Change from Randomization in Weekly Mean ADP Score

Description

Time Frame

Randomization and Week 12 of the Double-Blind Period

Secondary Outcome Measure Information:

Title

Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score

Description

Time Frame

Baseline and Week 12 of the Double-Blind Period

Title

Change from Baseline in Weekly Mean Sleep Interference Numerical Rating Scale (S-NRS)

Description

Time Frame

Baseline and Week 12 of the Double-Blind Period

Title

Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score

Description

Time Frame

Baseline and Week 12 of Double-Blind Period

Title

Proportion of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP

Description

Time Frame

Baseline and Week 12 of the Double-Blind Period

Title

Proportion of Participants with at least a 30% Reduction from Baseline in Weekly Mean ADP

Description

Time Frame

Baseline and Week 12 of Double-Blind Period

Title

Mean Weekly Amount of Rescue Medication

Description

Time Frame

Weekly from Baseline to Week 12 of the Double-Blind Period

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

Week 12 of the Double-Blind Period

Title

Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score

Description

Time Frame

Baseline and Week 12 of the Double-Blind Period

Title

Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double-Blind Period

Description

Time Frame

Week 5 to Week 17

Title

Area Under the Concentration-time Curve at Steady State

Time Frame

Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)

Title

Maximum Observed Concentration (Cmax) at Steady State

Time Frame

Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: This study will be conducted in subjects who have had a diagnosis of at least probable SFN, length-dependent distribution, for 6 months and ≤10 years prior to screening, defined as a history of the symptoms and clinical signs based on discussions at the ACTTION CONCEPPT meeting on diagnosis of SFN, Washington, DC March 2018, and confirmed by intraepidermal nerve fiber density (IENFD) values, and weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days of prior to the Screening visit. In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 [moderate non-proliferative diabetic retinopathy]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease or current class IV heart failure to be eligible for the study. Key Exclusion Criteria: Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802). Use of capsaicin patch within 3 months prior to Screening. Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1. Unable or unwilling to comply with the prohibited concomitant medication restrictions, including but not limited to UDP-glucuronosyltransferase (UGT) inducers and inhibitors, monoamine oxidase inhibitors (MAOIs), and Nav blockers. Use of over-the-counter medications, vitamin and mineral supplements, herbal remedies (including St. John's wort), dietary supplements, or foods (including grapefruit juice) that affect and UGTs. Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic index, including but not limited to digoxin. History of hemophilia or Von Willebrand's disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy. Any contraindication, as determined by the Investigator, to performing a skin biopsy for intraepidermal nerve fiber analysis. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Byala

Country

Bulgaria

Facility Name

UMHAT 'Dr Georgi Stranski' EAD

City

Pleven

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site

City

Sofia

Country

Bulgaria

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Research Site

City

Greenfield Park

State/Province

Quebec

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Recherche Médicale St-Jérôme Inc.

City

St-Jerome

State/Province

Quebec

Country

Canada

Facility Name

Research Site

City

Kingston

Country

Canada

Facility Name

Research Site

City

Winnipeg

Country

Canada

Facility Name

Fakultni Nemocnice Brno

City

Brno

Country

Czechia

Facility Name

Fakultni Nemocnice u sv. Anny v Brne

City

Brno

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava

City

Ostrava-Poruba

Country

Czechia

Facility Name

Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice

City

Pardubice

Country

Czechia

Facility Name

Fakultni nemocnice v Motole

City

Prague

Country

Czechia

Facility Name

Research Site

City

Aarhus

Country

Denmark

Facility Name

Research Site

City

Copenhagen

Country

Denmark

Facility Name

Research Site

City

Herlev

Country

Denmark

Facility Name

OUH

City

Odense

Country

Denmark

Facility Name

Research Site

City

Brest

State/Province

Finistere

Country

France

Facility Name

CHU Saint Etienne - Hôpital Nord

City

Saint Priest En Jarez

State/Province

Loire

Country

France

Facility Name

Hopital Salengro - CHRU de Lille

City

Lille

State/Province

Nord

Country

France

Facility Name

CHU Clermond Ferrand - Hopital Gabriel Montpied

City

Clermont Ferrand

State/Province

Puy De Dome

Country

France

Facility Name

Research Site

City

Venissieux

State/Province

Rhone

Country

France

Facility Name

Hôpital Ambroise Paré - Boulogne-Billancourt

City

Boulogne-Billancourt

Country

France

Facility Name

Research Site

City

Corbeil-Essonnes

Country

France

Facility Name

Hopital Henri Mondor

City

Creteil

Country

France

Facility Name

Research Site

City

Le Creusot

Country

France

Facility Name

Groupement Hospitalier Sud - Hôpital Bicêtre

City

Le Kremlin Bicêtre

Country

France

Facility Name

CHU Nice - Hôpital de l'Archet 1

City

Nice

Country

France

Facility Name

Hopital Lariboisiere

City

Paris

Country

France

Facility Name

Clinical Research

City

Böblingen

State/Province

Baden-Württemberg

Country

Germany

Facility Name

Research Site

City

Aschaffenburg

State/Province

Bayern

Country

Germany

Facility Name

Research Site

City

Kuenzing

State/Province

Bayern

Country

Germany

Facility Name

Clinical Research

City

Westerstede

State/Province

Niedersachsen

Country

Germany

Facility Name

Clinical Research

City

Muenster

State/Province

Nord Rhein Westfalen

Country

Germany

Facility Name

Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

City

Dortmund

State/Province

Nordrhein Westfalen

Country

Germany

Facility Name

Hausarzt- und Diabetologische Schwerpunktpraxis

City

Lage

State/Province

Sachsen Anhalt

Country

Germany

Facility Name

Zentrum fur Klinische Forschung

City

Bad Homburg

Country

Germany

Facility Name

Gemeinschaftspraxis für Neurologie

City

Berlin

Country

Germany

Facility Name

Research Site

City

Essen

Country

Germany

Facility Name

Diabetologische Schwerpunktpraxis Harburg

City

Hamburg

Country

Germany

Facility Name

Research Site

City

Mainz

Country

Germany

Facility Name

DKD Helios Klinik Wiesbaden

City

Wiesbaden

Country

Germany

Facility Name

Research Site

City

Wurzburg

Country

Germany

Facility Name

Research Site

City

Athens

Country

Greece

Facility Name

Research Site

City

Heraklion

Country

Greece

Facility Name

Research Site

City

Patras

Country

Greece

Facility Name

AHEPA General Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

Facility Name

Research Site

City

Baja

Country

Hungary

Facility Name

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

City

Bekescsaba

Country

Hungary

Facility Name

UNO Medical Trials Kft.

City

Budapest

Country

Hungary

Facility Name

Somogy Megyei Kaposi Mor Oktato Korhaz

City

Kaposvar

Country

Hungary

Facility Name

Research Site

City

Nyiregyhaza

Country

Hungary

Facility Name

Research Site

City

Pecs

Country

Hungary

Facility Name

Research Site

City

Szeged

Country

Hungary

Facility Name

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

City

Brescia

Country

Italy

Facility Name

Research Site

City

Genova

Country

Italy

Facility Name

Research Site

City

Milan

Country

Italy

Facility Name

Azienda Ospedaliero Univeraitaria Pisana

City

Pisa

Country

Italy

Facility Name

Università Campus Bio-Medico di Roma

City

Roma

Country

Italy

Facility Name

Research Site

City

Telese Terme

Country

Italy

Facility Name

Amsterdam UMC, Locatie AMC

City

Amsterdam

Country

Netherlands

Facility Name

Maastricht UMC+

City

Maastricht

Country

Netherlands

Facility Name

Research Site

City

Bydgoszcz

Country

Poland

Facility Name

Research Site

City

Chorzow

Country

Poland

Facility Name

PRATIA MCM Kraków

City

Kraków

Country

Poland

Facility Name

Research Site

City

Lublin

Country

Poland

Facility Name

Research Site

City

Oswiecim

Country

Poland

Facility Name

Praktyka Lekarska Ewa Krzyzagorska

City

Poznan

Country

Poland

Facility Name

Research Site

City

Warszawa

Country

Poland

Facility Name

Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska

City

Wroclaw

Country

Poland

Facility Name

Hospital General Universitario de Alicante

City

Alicante

Country

Spain

Facility Name

Hospital Universitari de Bellvitge

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Barcelona

Country

Spain

Facility Name

Hospital Universitario Reina Sofia

City

Cordoba

Country

Spain

Facility Name

Research Site

City

La Coruna

Country

Spain

Facility Name

Research Site

City

Madrid

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro Majadahonda

City

Majadahonda

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe

City

Valencia

Country

Spain

Facility Name

CHUV - Centre Hospitalier Universitaire Vaudois

City

Lausanne

Country

Switzerland

Facility Name

Ospedale Regionale di Lugano

City

Lugano

Country

Switzerland

Facility Name

Kantonspital St. Gallen

City

St. Gallen

Country

Switzerland

Facility Name

Research Site

City

Zurich

Country

Switzerland

Facility Name

Royal Hallamshire Hospital

City

Sheffield

State/Province

South Yorkshire

Country

United Kingdom

Facility Name

Clinical Reseach

City

Bath

Country

United Kingdom

Facility Name

Research Site

City

Ipswich

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

Country

United Kingdom

Facility Name

Guy's Hospital

City

London

Country

United Kingdom

Facility Name

King's College Hospital

City

London

Country

United Kingdom

Facility Name

St Pancras Clinical Research

City

London

Country

United Kingdom

Facility Name

The Royal London Hospital

City

London

Country

United Kingdom

Facility Name

Research Site

City

Manchester

Country

United Kingdom

Facility Name

John Radcliffe Hospital

City

Oxford

Country

United Kingdom

Facility Name

Research Site

City

Swansea

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

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