240
Participants
Start Date
November 22, 2018
Primary Completion Date
June 6, 2020
Study Completion Date
June 6, 2020
trazodone/gabapentin 2.5/25 mg
The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.
trazodone/gabapentin 5/50 mg
The total daily doses administered will be trazodone 15 mg and gabapentin 150 mg.
trazodone/gabapentin 10/100
The total daily doses administered will be trazodone 30 mg and gabapentin 300 mg.
Gabapentin
"The total daily doses administered will be:~* 600 mg from day 0 to day 6 (±1)~* 900 mg from day 7 (±1) to day 13 (±1)~* 1200 mg from day 14 (±1) to day 20 (±1)~* 1800 mg from day 21 (±1) to day 56 (±2)"
Placebo oral capsule
Two capsules, three times a day, for 8 weeks.
Neurosanatio s.r.o., Litomyšl, 570 01
Cerebrovaskulární poradna, s.r.o., Ostrava - Poruba, 70800
Nemocnice Pardubického kraje a.s. Pardubická nemocnice Neurologická klinika, Pardubice, 532 03
Diabetologická ambulance Milan Kvapil s.r.o., Praha 4, 149 00
Axon Clinical s.r.o, Praha 5, 15000
FORBELI s.r.o., Praha 6, 160 00
Clintrial s.r.o., Praha, 100 00
Fondation Hôtel Dieu Groupe SOS Service de Diabétologie, Le Creusot
GHR MSA - Hôpital Emile Muller Service de Diabétologie-Endocrinologie-Nutrition, Mulhouse
CHU de Nantes - Hôpital Guillaume-et-René-Laënnec Clinique d'Endocrinologie, maladies métaboliques et nutrition CIC Endocrino - Nutrition - UF 7015, Nantes Cedex 144 093
Centre de Recherche Clinique G.H.M les Portes du Sud Departement d'Endocrinologie, Vénissieux
Centrum Badań Klinicznych PI-House, Gdansk, 80-546
Silmedic Sp. z o.o., Katowice, 40-282
Pro Familia Altera Poradnia Wielospecjalistyczna, Katowice, 40-648
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET, Kraków, 31-261
NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin, 20-064
Instytut Medycyny Wsi im. Witolda Chodźki Klinika Diabetologii, Lublin, 20-090
Centrum Medyczne HCP Sp. z o.o., Poznań, 61-485
RCMed Oddział Sochaczew, Sochaczew, 96-500
Nasz Lekarz Przychodnie Medyczne, Toruń, 87-100
Medycyna Kliniczna, Warszawa, 00-874
Instytut Diabetologii, Warszawa, 04-736
WroMedica I. Bielicka, A. Strzałkowska s.c., Wrocław, 51- 685
Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy, Wrocław, 51-162
Medical Innovation Development and Research Unit (MIDRU) Heartlands Hospital, Birmingham
Diabetes Centre Wythenshawe Hospital, Manchester
Manchester Clinical Research Facility Manchester Royal Infirmary, Manchester
Diabetes Centre George Eliot Hospital NHS Trust, Nuneaton
Lancashire Clinical Research Facility The Avondale Unit Royal Preston Hospital, Preston
Clinical Research Facility Royal Hallamshire Hospital, Sheffield
Collaborators (1)
Chiltern International Inc.
INDUSTRY
Aziende Chimiche Riunite Angelini Francesco S.p.A
INDUSTRY