Zusammenfassende Beschreibung der Studie (Datenquelle: 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.
Untersuchte Krankheiten(Datenquelle: BASEC)
Neuropatia delle piccole fibre dolorosa confermata (NPF), idiopatica o associata a diabete mellito
Health conditions
(Datenquelle: WHO)
Small Fiber Neuropathy;Diabetes Mellitus
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: BASEC)
compresse di BIIB074 alle dosi di 200 mg e 350 mg somministrato due volte al giorno
Interventions
(Datenquelle: WHO)
Drug: BIIB074;Drug: Placebo
Kriterien zur Teilnahme an der Studie
(Datenquelle: 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
Ausschlusskriterien
(Datenquelle: 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
(Datenquelle: 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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Weitere Informationen zur Studie
Datum der Studienregistrierung
08.11.2017
Einschluss der ersten teilnehmenden Person
31.05.2018
Rekrutierungsstatus
Active, not recruiting
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Datenquelle: WHO)
Phase 2
Primäre Endpunkte
(Datenquelle: WHO)
Change from Randomization in Weekly Mean ADP Score;Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score
Sekundäre Endpunkte
(Datenquelle: 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
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Lausanne, Lugano, St Gallen, Zürich
Durchführungsländer
(Datenquelle: WHO)
Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
Claudio Gobbi
+41 91 811 6921
claudio.gobbi@eoc.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Medical Director
Biogen
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Medical Director
Biogen
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Comitato etico cantonale Ticino
Datum der Bewilligung durch die Ethikkommission
27.04.2018
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2018-00115
Secondary ID (Datenquelle: WHO)
2017-000991-27
802NP206
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