PMID- 9291171
OWN - NLM
STAT- MEDLINE
DCOM- 19971007
LR  - 20170214
IS  - 1352-4585 (Print)
IS  - 1352-4585 (Linking)
VI  - 3
IP  - 2
DP  - 1997 Apr
TI  - Intravenous immunoglobulin (IVIG) treatment for patients with primary or 
      secondary progressive multiple sclerosis -- outline of a double-blind randomized, 
      placebo-controlled trial.
PG  - 149-52
AB  - We present the design of a double-blind, randomised placebo-controlled phase III 
      study to evaluate safety and efficacy of IVIG in the treatment of patients 
      suffering from primary or secondary chronic progressive multiple sclerosis. The 
      primary endpoint is disability. Two measures of disability were chosen in order 
      to assess the primary end point (a) sustained improvement (assessed at month 6, 
      confirmed at month 9) and (b) progression to increasing disability of the disease 
      (sustained for 3 months) at any time during the course of this 2 years study. The 
      disability is measured by the Extended Disability Status Scale (EDSS). Secondary 
      end points include the assessment of visual function, functions of the upper 
      extremity, cognitive functions, depression and quality of life.
FAU - Poehlau, D
AU  - Poehlau D
AD  - Neurologische Uniklinik der Ruhr-Universitat Bochum am St. Josef Hospital, 
      Germany.
FAU - Federlein, J
AU  - Federlein J
FAU - Postert, T
AU  - Postert T
FAU - Sailer, M
AU  - Sailer M
FAU - Bethke, F
AU  - Bethke F
FAU - Kappos, L
AU  - Kappos L
FAU - Haas, J
AU  - Haas J
FAU - Przuntek, H
AU  - Przuntek H
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Mult Scler
JT  - Multiple sclerosis (Houndmills, Basingstoke, England)
JID - 9509185
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Placebos)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Humans
MH  - Immunoglobulins, Intravenous/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Multiple Sclerosis/physiopathology/*therapy
MH  - Patient Selection
MH  - Placebos
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 1997/04/01 00:00
MHDA- 1997/09/18 00:01
CRDT- 1997/04/01 00:00
PHST- 1997/04/01 00:00 [pubmed]
PHST- 1997/09/18 00:01 [medline]
PHST- 1997/04/01 00:00 [entrez]
AID - 10.1177/135245859700300217 [doi]
PST - ppublish
SO  - Mult Scler. 1997 Apr;3(2):149-52. doi: 10.1177/135245859700300217.