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A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

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A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

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Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

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qtz-ec-0004-clrrs-02-disc01-en-final-02.pdf

qtz-ec-0004-clls-disc01-en-final-02.pdf

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study. 
This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

A study to compare QUTENZA with pregabalin for the treatment of peripheral neuropathic pain (PNP) after 8 weeks of treatment

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to results on Astellas Clinical Study Results website

Site 191 Med Zentr Städreg Aachen GmbH

Site 332 Gartnavel General Hospital

Site 196 Neuro Centrum Odenwald

Site 175 CHU Caremeau

Site 283 SANERA, s.r.o.

Site 334 Seacroft Hospital

Site 243 NZOZ Poradnia Leczenia Bólu

Site 113 AKH Linz

Site 131 UZ Brussels

Site 204 Athens Naval Hospital

Site 222 A.O.U Ospedali Riuniti

Site 143 UMHAT - Stara Zagora

Site 145 Military Medical Academy

Site 211 Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet Fájdalom Ambulancia

Site 135 ZNA Middelheim

Site 171 Hospital Ambroise Pare

Site 226 Presidio Ospedale G.Mazzini

Site 261 Quantum Medical Center SRL

Site 183 D. Metreveli Medical Center

Site 133 Heilig Hart Ziekenhuis

Site 114 Klinikum Klagenfurt Worthersee

Site 335 The Christies NHS Foundation

Site 274 Saint-Petersburg State Medical University

Site 182 S. Khechinashvili University Clinic

Site 176 CH Regional de Valence

Site 326 Maramara University, Pendik Training and Research Hospital

Site 322 Ufuk University Dr Rıdvan Ege Training and Research Hospital

Site 331 The Walton Centre

Site 146 MHAT Alexandrovska Hospital

Site 161 Finnmedi OY

Site 281 AB-BA ambulancia

Site 141 Centre for Mental Health

Site 302 Hospital Plató

Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

Site 271 First Moscow State Medical University named after I.M. Sechenov

Site 195 Universitätsklinikum Bonn

Site 212 Pécsi Tudományegyetem Klinikai Központ Neurológiai Klinika

Site 201 Aretaieio University Hospital

Site 162 Vassa Central Hospital

Site 303 Hospital Universitario Virgen

Site 102 Medical Center Erebuni

Site 311 Karolinska University Hospital

Site 101 Medical Union 2

Site 225 Policlinico San Donato

Site 272 City Clinical Hospital # 12

Site 245 Poradnia Leczenia Bólu, Uniwer

Site 203 Aretaieio/Maginio Hospital

Site 229 Azienda Ospedaliero di Perugia

Site 199 Bergmannstrost

Site 252 Instituto Portuges de Oncologic

Site 223 AOU San Giovanni Battista

Site 142 UMHAT – Pleven

Site 323 Ege University Medical Faculty Hospital

Site 273 Military Medical Academy

Site 178 Centre Alexis Vautrin

Site 137 Univ. Ziekenhuis Antwerpen

Site 246 NZOZ Poradnia Leczenia Bolu Pr

Site 194 Schmerz Palliativznt Wiesbaden

Site 251 Hospital Beatriz Angelo

Site 147 MHAT Sv. Ivan Rilski

Site 115 Medical University Innsbruck

Site 325 Pamukkale University Medical Faculty Hospital

Site 174 Hopital Neurologique Pierre W

Site 313 SU/Östra

Site 136 UZ Pellenberg

Site 192 Universitätsklinikum Giessen

Site 121 Vitebsk Regional Clinical Hospital # 1

Site 264 Spitalul Clinic Colentina

Site 151 Fakultni nemocnice Plzen

Site 173 CHU Hopital Nord

Site 132 Ziekenhuis Oost-Limburg

Site 134 Grand Hospital de Charleroi

Site 263 Spitalul Clinic Judetean de Ur

Site 144 Tokuda Hospital Sofia

Site 312 Karolinska University Hospital

Site 244 Niepubliczny Zakład Opieki Zdr

Site 104 Medical Center "Surb Nerses Mets"

Site 193 Universitätsklinikum Münster

Site 111 AKH Universitatsklinik

Site 138 Cliniques Universitaires Saint

Site 278 Semashko Regional Clinical Hospital

Site 202 Hippokration General Hospital of Athens

Site 197 Universitätsklinikum Würzburg

Site 123 Grodno Regional Clinical Hospital

Site 301 Hospital General Universitario de Alicante

Site 292 University Medical Centre Mari

Site 122 Republican Clinical Medical Center

Site 324 Dokuz Eylul University Medical Faculty Hospital

Site 277 Hospital №40 of Kurortniy

Site 321 Hacettepe University Medical Faculty Hospital

Site 228 Azienda Ospedaliero di Perugia

Site 336 Leicester Royal Infirmary

Site 275 Russian State Medical University named after N.I. Pirogov

Site 232 Ospedale Niguarda Ca' Granda

Site 227 Azienda Ospedaliera Universita

Site 172 Hospital Saint Antoine

Site 103 Scientific research Institute of physiotherapy

Site 112 Wilhelminenspital

Site 282 Neurological surgery

Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S

Qutenza versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, non-inferiority efficacy and tolerability study

Optimal therapeutic effect is defined as:
− No change in background chronic pain medication and no
discontinuation of study drug due to lack of efficacy or
tolerability prior to Week 8
− At least a 30% reduction in the “average pain for the past 24
hours” NPRS score, from baseline to Week 8, and
− No moderate or severe adverse drug reactions (ADRs) during
the stable Treatment Period

NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)

NPRS score from baseline to week 8, and from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)

NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Weeks 1 to 8

Assessed by at least a 30% reduction  in “average pain for the past 24 hours” NPRS score

As assessed by:
•	Proportion of subjects who discontinue study drug or withdraw from the study due to either a lack of efficacy or tolerability 
•	Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and Week 8

As assessed by willingness to continue treatment at Week 8

Number of contacts with health professionals

Collected as self-rated health-related complaints by the subject and then medically confirmed and causality assigned by the investigator

Assessed using Neuropathic Pain Symptom Inventory (NPSI) scores

By the pattern of sensory symptoms as defined using NPSI scores at baseline.