A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
Phase: PHASE3
Conditions: Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Sponsor: Alexion Pharmaceuticals, Inc.

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Protocol ECU-NMO-301 
 
Alexion Pharmaceuticals, Inc. 
Version 6.0 
 
01 July 2016 
Figure 1: 
Relationship between Serum Concentration of Eculizumab and Free C5 Inhibition 
 
 
Figure 2: 
Relationship between Serum Concentration of Eculizumab and Percent Hemolysis 
(Induction and Maintenance Periods) 
 
 
Ecu
l
izumab Concentrat
ions (g/mL)
Free C5 (g/mL)
0
20
40
60
80
100
120
0
100
200
300
400
500
600
700
800
C08-002A/B
C08-003A/B
C09-001r
Ecu
l
izumab Concentrat
ions (g/mL)
Hemolysis (%)
0
20
40
60
80
100
0
100
200
300
400
500
600
700
800
C08-002A/B
C08-003A/B
C09-001r
CONFIDENTIAL 
 
Page 33 of 122 

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Protocol ECU-NMO-301 
 
Alexion Pharmaceuticals, Inc. 
Version 6.0 
 
01 July 2016 
APPENDIX 5. HAUSER AMBULATION INDEX (33) 
 
� 0 = Asymptomatic; fully active. 
� 1 = Walks normally, but reports fatigue that interferes with athletic or other demanding activities. 
� 2 = Abnormal gait or episodic imbalance; gait disorder is noticed by family and friends; able to 
walk 25 feet (8 meters) in 10 seconds or less. 
� 3 = Walks independently; able to walk 25 feet in 20 seconds or less. 
� 4 = Requires unilateral support (cane or single crutch) to walk; walks 25 feet in   20 seconds or 
less. 
� 5 = Requires bilateral support (canes, crutches, or walker) and walks 25 feet in 20 seconds or 
less; or requires unilateral support but needs more than 20 seconds to walk 25 feet. 
� 6 = Requires bilateral support and more than 20 seconds to walk 25 feet; may use wheelchair* on 
occasion. 
� 7 = Walking limited to several steps with bilateral support; unable to walk 25 feet; may use 
wheelchair* for most activities. 
� 8 = Restricted to wheelchair; able to transfer self independently. 
� 9 = Restricted to wheelchair; unable to transfer self independently. 
*The use of a wheelchair may be determined by lifestyle and motivation. It is expected that 
patients in Grade 7 will use a wheelchair more frequently than those in Grades 5 or 6. 
Assignment of a grade in the range of 5 to 7, however, is determined by the patient’s ability to 
walk a given distance, and not by the extent to which the patient uses a wheelchair. 
 
 
 
 
 
CONFIDENTIAL 
 
Page 107 of 122 

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