Brève description de l’étude (Source de données: BASEC)
Si tratta di uno studio di fase 2 multicentrico. L’obiettivo dello studio consiste nel valutare l’efficacia e la sicurezza di BIIB074 alle dosi di 200 mg e 350 mg somministrato due volte al giorno rispetto al placebo.
La durata della partecipazione allo studio sarà di circa 26 settimane, incluso un periodo di valutazione allo screening della durata massima di 21 giorni, un periodo di riduzione graduale della dose (se pertinente) della durata massima di 14 giorni, un periodo di washout di 5 giorni, un periodo preliminare in aperto di 4 settimane, un periodo in doppio cieco di 12 settimane e un periodo di follow-up di 4 settimane.
Maladies étudiées(Source de données: BASEC)
Neuropatia delle piccole fibre dolorosa confermata (NPF), idiopatica o associata a diabete mellito
Health conditions
(Source de données: WHO)
Small Fiber Neuropathy;Diabetes Mellitus
Maladie rare
(Source de données: BASEC)
Non
Intervention étudiée (p. ex., médicament, thérapie, campagne)
(Source de données: BASEC)
compresse di BIIB074 alle dosi di 200 mg e 350 mg somministrato due volte al giorno
Interventions
(Source de données: WHO)
Drug: BIIB074;Drug: Placebo
Critères de participation à l’étude
(Source de données: BASEC)
-Maschi e femmine di età.18 anni, compresi, al momento del consenso informato.
-Questo studio sarà condotto in soggetti che hanno ricevuto una diagnosi di SFN per lo meno probabile da 6 mesi o più, basata sulla diagnosi clinica e confermata in base ai valori della densità delle fibre nervose intraepidermiche, e un punteggio settimanale del dolore medio giornaliero .5 e .9 su una scala di valutazione numerica dell’intensità del dolore a 11 punti nell’arco degli ultimi 7 giorni di screening.
-Oltre a questi criteri, per essere idonei a partecipare allo studio, i soggetti con diabete devono avere un’HbA1c .11%, essere trattati con ipoglicemici orali e/o insulina sottocutanea o sottoposti a dieta, non devono presentare evidenze di ulcere, retinopatia avanzata (definita come maggiore dello Stato 3 [retinopatia diabetica non proliferativa moderata]) (Gruppo di ricerca 2017 coinvolto nella Sperimentazione sul controllo e le complicazioni del diabete (Epidemiologia sugli interventi e le complicanze del diabete), neuropatia grave o malattia aterosclerotica ostruttiva causate dal diabete.
NOTA: possono essere applicati altri criteri di inclusione definiti dal protocollo
Critères d’exclusion
(Source de données: BASEC)
1. Precedente esposizione a BIIB074 (precedentemente noto come CNV1014802 o GSK1014802).
2. Uso di cerotti di capsaicina nei 3 mesi precedenti lo screening.
3. Non in grado o non disposto ad interrompere i farmaci concomitanti per il dolore neuropatico durante il periodo di riduzione graduale di 2 settimane che si sovrappone alla prima settimana del periodo di run-in in aperto.
Inclusion/Exclusion Criteria
(Source de données: WHO)
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.
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Plus d’informations sur l’étude
Date d’enregistrement de l’étude
8 nov. 2017
Intégration du premier participant
31 mai 2018
Statut de recrutement
Active, not recruiting
Titre scientifique
(Source de données: WHO)
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
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Source de données: WHO)
Phase 2
Points finaux primaires
(Source de données: WHO)
Change from Randomization in Weekly Mean ADP Score;Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score
Points finaux secondaires
(Source de données: WHO)
Maximum Observed Concentration (Cmax) at Steady State;Area Under the Concentration-time Curve at Steady State;Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double-Blind Period;Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score;Patient Global Impression of Change (PGIC);Mean Weekly Amount of Rescue Medication;Proportion of Participants with at least a 30% Reduction from Baseline in Weekly Mean ADP;Proportion of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP;Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score;Change from Baseline in Weekly Mean Sleep Interference Numerical Rating Scale (S-NRS);Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Lieux de réalisation des études en Suisse
(Source de données: BASEC)
Lausanne, Lugano, St-Gall, Zurich
Pays où sont réalisées les études
(Source de données: WHO)
Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contact pour plus d’informations sur l’étude
Données sur la personne de contact en Suisse
(Source de données: BASEC)
Claudio Gobbi
+41 91 811 6921
claudio.gobbi@eoc.ch
Contact pour des informations générales
(Source de données: WHO)
Medical Director
Biogen
Contact pour des informations scientifiques
(Source de données: WHO)
Medical Director
Biogen
Autorisation de la commission d’éthique (Source de données: BASEC)
Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)
Comitato etico cantonale Ticino
Date d’autorisation de la commission d’éthique
27.04.2018
Plus de numéros d’identification d’étude
Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID)
(Source de données: BASEC)
2018-00115
Secondary ID (Source de données: WHO)
2017-000991-27
802NP206
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