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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03339336
Other study ID # 802NP206
Secondary ID 2017-000991-27
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 31, 2018
Est. completion date April 12, 2021

Study information

Verified date April 2021
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 265
Est. completion date April 12, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: 1. 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. 2. 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: 1. Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802). 2. Use of capsaicin patch within 3 months prior to Screening. 3. Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1. 4. 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. 5. 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. 6. Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic index, including but not limited to digoxin. 7. History of hemophilia or Von Willebrand's disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy. 8. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BIIB074
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.

Locations

Country Name City State
Bulgaria Research Site Byala
Bulgaria UMHAT 'Dr Georgi Stranski' EAD Pleven
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sofia
Canada Research Site Greenfield Park Quebec
Canada Research Site Kingston
Canada Research Site Montreal Quebec
Canada Recherche Médicale St-Jérôme Inc. St-Jerome Quebec
Canada Toronto General Hospital Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Canada Research Site Winnipeg
Czechia Fakultni Nemocnice Brno Brno
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno
Czechia Research Site Hradec Kralove
Czechia Fakultni nemocnice Ostrava Ostrava-Poruba
Czechia Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice Pardubice
Czechia Fakultni nemocnice v Motole Prague
Denmark Research Site Aarhus
Denmark Research Site Copenhagen
Denmark Research Site Herlev
Denmark OUH Odense
France Hôpital Ambroise Paré - Boulogne-Billancourt Boulogne-Billancourt
France Research Site Brest Finistere
France CHU Clermond Ferrand - Hopital Gabriel Montpied Clermont Ferrand Puy De Dome
France Research Site Corbeil-Essonnes
France Hopital Henri Mondor Creteil
France Research Site Le Creusot
France Groupement Hospitalier Sud - Hôpital Bicêtre Le Kremlin Bicêtre
France Hopital Salengro - CHRU de Lille Lille Nord
France CHU Nice - Hôpital de l'Archet 1 Nice
France Hopital Lariboisiere Paris
France CHU Saint Etienne - Hôpital Nord Saint Priest En Jarez Loire
France Research Site Venissieux Rhone
Germany Research Site Aschaffenburg Bayern
Germany Zentrum fur Klinische Forschung Bad Homburg
Germany Gemeinschaftspraxis für Neurologie Berlin
Germany Clinical Research Böblingen Baden-Württemberg
Germany Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch Dortmund Nordrhein Westfalen
Germany Research Site Essen
Germany Diabetologische Schwerpunktpraxis Harburg Hamburg
Germany Research Site Kuenzing Bayern
Germany Hausarzt- und Diabetologische Schwerpunktpraxis Lage Sachsen Anhalt
Germany Research Site Mainz
Germany Clinical Research Muenster Nord Rhein Westfalen
Germany Clinical Research Westerstede Niedersachsen
Germany DKD Helios Klinik Wiesbaden Wiesbaden
Germany Research Site Wurzburg
Greece Research Site Athens
Greece Research Site Heraklion
Greece Research Site Patras
Greece AHEPA General Hospital of Thessaloniki Thessaloniki
Hungary Research Site Baja
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Bekescsaba
Hungary UNO Medical Trials Kft. Budapest
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Research Site Nyiregyhaza
Hungary Research Site Pecs
Hungary Research Site Szeged
Italy Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia
Italy Research Site Genova
Italy Research Site Milan
Italy Azienda Ospedaliero Univeraitaria Pisana Pisa
Italy Università Campus Bio-Medico di Roma Roma
Italy Research Site Telese Terme
Netherlands Amsterdam UMC, Locatie AMC Amsterdam
Netherlands Maastricht UMC+ Maastricht
Poland Research Site Bydgoszcz
Poland Research Site Chorzow
Poland PRATIA MCM Kraków Kraków
Poland Research Site Lublin
Poland Research Site Oswiecim
Poland Praktyka Lekarska Ewa Krzyzagorska Poznan
Poland Research Site Warszawa
Poland Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska Wroclaw
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitari de Bellvitge Barcelona
Spain Research Site Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Research Site La Coruna
Spain Research Site Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda
Spain Hospital Universitari i Politecnic La Fe Valencia
Switzerland CHUV - Centre Hospitalier Universitaire Vaudois Lausanne
Switzerland Ospedale Regionale di Lugano Lugano
Switzerland Kantonspital St. Gallen St. Gallen
Switzerland Research Site Zurich
United Kingdom Clinical Reseach Bath
United Kingdom Research Site Ipswich
United Kingdom Research Site Liverpool
United Kingdom Guy's Hospital London
United Kingdom King's College Hospital London
United Kingdom St Pancras Clinical Research London
United Kingdom The Royal London Hospital London
United Kingdom Research Site Manchester
United Kingdom John Radcliffe Hospital Oxford
United Kingdom Royal Hallamshire Hospital Sheffield South Yorkshire
United Kingdom Research Site Swansea

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and Week 12 of the Double-Blind Period
Primary 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. Randomization and Week 12 of the Double-Blind Period
Secondary 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. Baseline and Week 12 of the Double-Blind Period
Secondary 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. Baseline and Week 12 of the Double-Blind Period
Secondary 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. Baseline and Week 12 of Double-Blind Period
Secondary 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. Baseline and Week 12 of the Double-Blind Period
Secondary 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. Baseline and Week 12 of Double-Blind Period
Secondary 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. Weekly from Baseline to Week 12 of the Double-Blind Period
Secondary 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." Week 12 of the Double-Blind Period
Secondary 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. Baseline and Week 12 of the Double-Blind Period
Secondary 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. Week 5 to Week 17
Secondary Area Under the Concentration-time Curve at Steady State 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)
Secondary Maximum Observed Concentration (Cmax) at Steady State 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)
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