Trial Outcomes & Findings for Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke (NCT NCT00200356)
NCT ID: NCT00200356
Last Updated: 2026-01-07
Results Overview
The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
COMPLETED
PHASE4
401 participants
3 months
2026-01-07
Participant Flow
Participant milestones
| Measure |
Edaravone
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
202
|
|
Overall Study
Safety Analysis Set
|
194
|
198
|
|
Overall Study
COMPLETED
|
191
|
195
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Edaravone
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
|
Overall Study
Protocol Violation
|
4
|
4
|
|
Overall Study
Nontreatment
|
1
|
0
|
Baseline Characteristics
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Edaravone
n=191 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
birth-19 years
|
0 years
n=37 Participants
|
0 years
n=56 Participants
|
0 years
n=95 Participants
|
|
Age, Customized
20-64 years
|
64 years
n=37 Participants
|
58 years
n=56 Participants
|
122 years
n=95 Participants
|
|
Age, Customized
65- years
|
127 years
n=37 Participants
|
137 years
n=56 Participants
|
264 years
n=95 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=37 Participants
|
77 Participants
n=56 Participants
|
147 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=37 Participants
|
118 Participants
n=56 Participants
|
239 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
Outcome measures
| Measure |
Edaravone
n=191 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
Death
|
2 participants
|
1 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
Score(0-1)
|
109 participants
|
98 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
0
|
46 participants
|
39 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
1
|
63 participants
|
59 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
2
|
37 participants
|
40 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
3
|
22 participants
|
29 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
4
|
19 participants
|
24 participants
|
|
the Rate of Patients With a Modified Rankin Scale Score of 0-1
5
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 monthsThe Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=191 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Barthel Index Score
|
148 participants
|
133 participants
|
SECONDARY outcome
Timeframe: Before treatment initiationThe NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).
Outcome measures
| Measure |
Edaravone
n=191 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Baseline NIH Stroke Scale Score
|
3.7 scores on a scale
Standard Deviation 2.3
|
3.8 scores on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 14 daysThe NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=190 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=193 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
NIH Stroke Scale Score at 14 Days
|
98 participants
|
108 participants
|
SECONDARY outcome
Timeframe: 1 monthThe NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=190 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
NIH Stroke Scale Score at 1 Month
|
117 participants
|
119 participants
|
SECONDARY outcome
Timeframe: 3 monthsThe NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=191 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
NIH Stroke Scale Score at 3 Months
|
135 participants
|
140 participants
|
SECONDARY outcome
Timeframe: 14 daysThe Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=190 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=193 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Japan Stroke Scale (Motor Function) Score at 14 Days
|
4.521 units on a scale
Standard Deviation 6.651
|
4.686 units on a scale
Standard Deviation 6.872
|
SECONDARY outcome
Timeframe: 1 monthThe Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=190 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=195 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Japan Stroke Scale (Motor Function) Score at 1 Month
|
3.632 units on a scale
Standard Deviation 6.086
|
3.680 units on a scale
Standard Deviation 5.885
|
SECONDARY outcome
Timeframe: 3 monthsThe Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.
Outcome measures
| Measure |
Edaravone
n=189 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=194 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Japan Stroke Scale (Motor Function) Score at 3 Months
|
2.507 units on a scale
Standard Deviation 5.232
|
2.927 units on a scale
Standard Deviation 5.361
|
SECONDARY outcome
Timeframe: 6 monthsThe number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
Outcome measures
| Measure |
Edaravone
n=186 Participants
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=193 Participants
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Modified Rankin Scale Score
|
112 participants
|
108 participants
|
Adverse Events
Edaravone
Ozagrel
Serious adverse events
| Measure |
Edaravone
n=194 participants at risk
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=198 participants at risk
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.52%
1/194
|
0.00%
0/198
|
|
Cardiac disorders
Angina pectoris
|
0.52%
1/194
|
0.00%
0/198
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.52%
1/194
|
0.00%
0/198
|
|
Cardiac disorders
Arrhythmia
|
0.52%
1/194
|
0.00%
0/198
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/194
|
0.51%
1/198
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.52%
1/194
|
0.00%
0/198
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/194
|
0.51%
1/198
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/194
|
0.51%
1/198
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.52%
1/194
|
0.00%
0/198
|
|
Nervous system disorders
Cerebral infarction
|
2.6%
5/194
|
5.6%
11/198
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/194
|
0.51%
1/198
|
|
Psychiatric disorders
Depression
|
0.52%
1/194
|
0.00%
0/198
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.52%
1/194
|
0.00%
0/198
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.52%
1/194
|
0.00%
0/198
|
|
Infections and infestations
Erysipelas
|
0.00%
0/194
|
0.51%
1/198
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.52%
1/194
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.52%
1/194
|
0.00%
0/198
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/194
|
1.0%
2/198
|
|
Gastrointestinal disorders
Ileus
|
1.0%
2/194
|
0.00%
0/198
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.52%
1/194
|
0.00%
0/198
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/194
|
0.51%
1/198
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.52%
1/194
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.52%
1/194
|
0.00%
0/198
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/194
|
0.51%
1/198
|
|
Infections and infestations
Pneumonia
|
1.0%
2/194
|
0.51%
1/198
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/194
|
0.51%
1/198
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.52%
1/194
|
0.00%
0/198
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/194
|
0.51%
1/198
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Sciatica
|
0.00%
0/194
|
0.51%
1/198
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/194
|
0.51%
1/198
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/194
|
0.51%
1/198
|
|
Nervous system disorders
Thrombotic stroke
|
0.52%
1/194
|
0.00%
0/198
|
|
Nervous system disorders
Transient ischemic attack
|
1.0%
2/194
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/194
|
0.51%
1/198
|
|
Infections and infestations
Urinary tract infection
|
0.52%
1/194
|
0.51%
1/198
|
|
Ear and labyrinth disorders
Vertigo
|
0.52%
1/194
|
0.00%
0/198
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/194
|
0.51%
1/198
|
Other adverse events
| Measure |
Edaravone
n=194 participants at risk
Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
|
Ozagrel
n=198 participants at risk
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
30.4%
59/194
|
32.3%
64/198
|
|
Gastrointestinal disorders
Diarrhea
|
5.2%
10/194
|
3.0%
6/198
|
|
Nervous system disorders
Headache
|
5.7%
11/194
|
6.1%
12/198
|
|
Psychiatric disorders
Insomnia
|
12.4%
24/194
|
16.7%
33/198
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
19/194
|
6.6%
13/198
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
9/194
|
5.1%
10/198
|
|
Infections and infestations
Urinary tract infection
|
4.6%
9/194
|
5.6%
11/198
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
11/194
|
8.6%
17/198
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER