142
Participants
Start Date
September 27, 2017
Primary Completion Date
September 5, 2019
Study Completion Date
September 5, 2019
NewGam
In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding
Jahn Ferenc Del Pesti Korhaz, Budapest
St. Naum Hospital, Sofia
MHAT Puls EOOD, Blagoevgrad
National Medical Academy Of Postgraduate Education Named After P.L. Shupyk, Kyiv
Volyn Regional Clinical Hospital, Lutsk
Szegedi Tudományegyetem ÁOK Neurológiai Klinika, Szeged
Vinnytsia National Medical University, Vinnytsia
University Medical Center Goettigen, Goettigen
Municipal Institution Zaporizhzhya Regional Clinical Hospital, Zaporizhzhya
Ivano Frankivsk National Medical University, Ivano-Frankivsk
Neurology Research Centre, Moscow
National Medical Research Centre of Psychiatry and Neurology n.a. V.M.Bekhterev, Saint Petersburg
City Multifield Hospital #2, Saint Petersburg
Republican Clinical Neurological Centre, Kazan'
Theo Health S.R.L., Brasov
Nizhny Novgorod Regional Clinical Hospital N.A. N.A.Semashko, Nizhny Novgorod
"Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta", Constanța
Toronto General Hospital, Toronto
Octapharma Research Site, Montreal
Outpatient Clinic of Neurology, Hradec Králové
Regional Hospital Pardubice, Pardubice
Thomayer Faculty Hospital, Prague
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Neurologii, Lublin
Wojewodzki Szpital Specjalistyczny W Olsztynie, Olsztyn
Uniwersytecki Szpital Kliniczny, Wroclaw
Institutul Clinic Fundeni, Bucharest
Lead Sponsor
Octapharma
INDUSTRY