Trial Outcomes & Findings for Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia (NCT NCT06834490)
NCT ID: NCT06834490
Last Updated: 2025-10-06
Results Overview
The Montreal Cognitive Assessment (MoCA) is used to measure the degree of cognitive impairment in patients with CCI. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected after treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)
Results posted on
2025-10-06
Participant Flow
Participants were recruited based on protocol requirements at 15 clinical sites between November 2019 and December 2020. The first participant was enrolled on 05 November, 2019 and the last participant was enrolled on 14 September, 2020.
Of 330 screened participants, 318 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Main (Mexidol)
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
159
|
|
Overall Study
COMPLETED
|
157
|
155
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
Baseline characteristics by cohort
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=159 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
104 Participants
n=159 Participants
|
99 Participants
n=159 Participants
|
203 Participants
n=318 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=159 Participants
|
60 Participants
n=159 Participants
|
115 Participants
n=318 Participants
|
|
Age, Continuous
|
60.08 Years
STANDARD_DEVIATION 9.86 • n=159 Participants
|
60.73 Years
STANDARD_DEVIATION 9.03 • n=159 Participants
|
60.44 Years
STANDARD_DEVIATION 9.59 • n=318 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=159 Participants
|
121 Participants
n=159 Participants
|
240 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=159 Participants
|
38 Participants
n=159 Participants
|
78 Participants
n=318 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=159 Participants
|
8 Participants
n=159 Participants
|
18 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=159 Participants
|
151 Participants
n=159 Participants
|
300 Participants
n=318 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=159 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=318 Participants
|
|
Region of Enrollment
Russia
|
151 Participants
n=151 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
151 Participants
n=151 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
302 Participants
n=302 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
|
Region of Enrollment
Uzbekistan
|
8 Participants
n=8 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
8 Participants
n=8 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
16 Participants
n=16 Participants • There were 302 participants from Russia and 16 participants from Uzbekistan. 302 plus 16 equals 318 (ITT-population).
|
|
The Montreal Cognitive Assessment scores at Visit 0 (7 days before treatment)
|
21.53 score on a scale
STANDARD_DEVIATION 2.27 • n=159 Participants • The results obtained at Visit 0 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
21.80 score on a scale
STANDARD_DEVIATION 1.96 • n=158 Participants • The results obtained at Visit 0 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
21.67 score on a scale
STANDARD_DEVIATION 2.13 • n=317 Participants • The results obtained at Visit 0 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The SF-36 questionnaire scores at Visit 1 (Day 1 of treatment)
The SF-36 questionnaire: physical health
|
44.21 score on a scale
STANDARD_DEVIATION 8.58 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
44.12 score on a scale
STANDARD_DEVIATION 7.92 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
44.21 score on a scale
STANDARD_DEVIATION 8.28 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The SF-36 questionnaire scores at Visit 1 (Day 1 of treatment)
The SF-36 questionnaire: mental health
|
44.12 score on a scale
STANDARD_DEVIATION 9.18 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
44.95 score on a scale
STANDARD_DEVIATION 9.20 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
44.51 score on a scale
STANDARD_DEVIATION 9.18 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The Multidimensional Fatigue Inventory scores at Visit 1 (Day 1 of treatment)
|
59.77 score on a scale
STANDARD_DEVIATION 13.35 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
58.79 score on a scale
STANDARD_DEVIATION 13.78 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
59.25 score on a scale
STANDARD_DEVIATION 13.55 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The Beck Anxiety Inventory scores at Visit 1 (Day 1 of treatment)
|
11.85 score on a scale
STANDARD_DEVIATION 8.11 • n=159 Participants • The results obtained at Visit 1 were used as reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
11.23 score on a scale
STANDARD_DEVIATION 8.54 • n=158 Participants • The results obtained at Visit 1 were used as reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
11.51 score on a scale
STANDARD_DEVIATION 8.33 • n=317 Participants • The results obtained at Visit 1 were used as reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
A.M.Wein's questionnaire scores at Visit 1 (Day 1 of treatment)
|
26.59 score on a scale
STANDARD_DEVIATION 13.63 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
26.28 score on a scale
STANDARD_DEVIATION 12.70 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
26.43 score on a scale
STANDARD_DEVIATION 13.13 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The Digit Symbol Substitution Test scores at Visit 1 (Day 1 of treatment)
|
32.84 score on a scale
STANDARD_DEVIATION 10.94 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
33.87 score on a scale
STANDARD_DEVIATION 12.24 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
33.36 score on a scale
STANDARD_DEVIATION 11.63 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
|
The Tinetti test scores at Visit 1 (Day 1 of treatment)
|
32.64 score on a scale
STANDARD_DEVIATION 5.30 • n=159 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
33.30 score on a scale
STANDARD_DEVIATION 5.23 • n=158 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
32.99 score on a scale
STANDARD_DEVIATION 5.27 • n=317 Participants • The results obtained at Visit 1 were used as the reference for the estimation of the efficacy. The statistical analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
|
PRIMARY outcome
Timeframe: Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Montreal Cognitive Assessment (MoCA) is used to measure the degree of cognitive impairment in patients with CCI. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected after treatment.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0
MoCA Scores at Visit 5
|
25.72 score on a scale
Standard Deviation 2.47
|
23.95 score on a scale
Standard Deviation 2.58
|
|
Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0
Difference in comparison with Visit 0
|
4.22 score on a scale
Standard Deviation 2.59
|
2.17 score on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2) and Day 44±2 (Visit 4) compared with the baseline level (Visit 0, 7 days before treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Montreal Cognitive Assessment (MoCA) is used to measure the changes in the severity of cognitive impairment at Visits 2 and 4 in comparison to Visit 0. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4
MoCA scores at Visit 2
|
23.82 score on a scale
Standard Deviation 2.28
|
23.10 score on a scale
Standard Deviation 2.17
|
|
Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4
Difference at Visit 2 in comparison to Visit 0
|
2.30 score on a scale
Standard Deviation 1.96
|
1.31 score on a scale
Standard Deviation 1.64
|
|
Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4
MoCA scores at Visit 4
|
25.06 score on a scale
Standard Deviation 2.37
|
23.75 score on a scale
Standard Deviation 2.34
|
|
Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4
Difference at Visit 4 in comparison to Visit 0
|
3.54 score on a scale
Standard Deviation 2.36
|
1.98 score on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The SF-36 questionnaire is used between Visit 1 and Visits 2, 4, 5. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
SF-36: physical health (Visit 2)
|
44.81 score on a scale
Standard Deviation 8.28
|
44.94 score on a scale
Standard Deviation 7.83
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
Difference at Visit 2 in comparison with Visit 1
|
0.60 score on a scale
Standard Deviation 5.29
|
0.79 score on a scale
Standard Deviation 4.53
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
SF-36: physical health (Visit 4)
|
46.52 score on a scale
Standard Deviation 7.90
|
46.07 score on a scale
Standard Deviation 7.78
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
Difference at Visit 4 in comparison with Visit 1
|
2.35 score on a scale
Standard Deviation 6.07
|
2.03 score on a scale
Standard Deviation 5.60
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
SF-36: physical health (Visit 5)
|
47.31 score on a scale
Standard Deviation 7.96
|
46.27 score on a scale
Standard Deviation 7.77
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
Difference at Visit 5 in comparison with Visit 1
|
3.08 score on a scale
Standard Deviation 6.70
|
2.23 score on a scale
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The SF-36 questionnaire is used between Visit 1 and Visits 2, 4, 5. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
Difference at Visit 5 in comparison with Visit 1
|
6.36 score on a scale
Standard Deviation 8.14
|
3.46 score on a scale
Standard Deviation 8.05
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
SF-36: mental health (Visit 2)
|
46.64 score on a scale
Standard Deviation 8.91
|
46.40 score on a scale
Standard Deviation 9.16
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
Difference at Visit 2 in comparison with Visit 1
|
2.52 score on a scale
Standard Deviation 6.75
|
1.49 score on a scale
Standard Deviation 4.70
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
SF-36: mental health (Visit 4)
|
48.46 score on a scale
Standard Deviation 8.74
|
47.38 score on a scale
Standard Deviation 9.14
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
Difference at Visit 4 in comparison with Visit 1
|
4.30 score on a scale
Standard Deviation 7.85
|
2.45 score on a scale
Standard Deviation 6.46
|
|
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
SF-36: mental health (Visit 5)
|
50.51 score on a scale
Standard Deviation 7.96
|
48.40 score on a scale
Standard Deviation 8.77
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Multidimensional Fatigue Inventory (MFI-20) is used between Visit 1 and Visits 2, 4, 5. MFI-20 is a 20-item self-administered questionnaire designed to measure fatigue in five four-item subscales: General fatigue, Physical fatigue, Reduced activity, Reduced motivation and Mental fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
MFI-20 scores at Visit 2
|
56.51 score on a scale
Standard Deviation 13.71
|
57.14 score on a scale
Standard Deviation 13.79
|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
Difference at Visit 2 in comparison with Visit 1
|
-3.26 score on a scale
Standard Deviation 9.58
|
-1.68 score on a scale
Standard Deviation 7.24
|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
MFI-20 scores at Visit 4
|
53.44 score on a scale
Standard Deviation 14.20
|
55.23 score on a scale
Standard Deviation 14.14
|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
Difference at Visit 4 in comparison with Visit 1
|
-6.37 score on a scale
Standard Deviation 11.61
|
-3.81 score on a scale
Standard Deviation 10.15
|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
MFI-20 scores at Visit 5
|
51.47 score on a scale
Standard Deviation 13.89
|
54.24 score on a scale
Standard Deviation 14.00
|
|
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
Difference at Visit 5 in comparison with Visit 1
|
-8.33 score on a scale
Standard Deviation 12.68
|
-4.80 score on a scale
Standard Deviation 11.42
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
BAI scores at Visit 2
|
9.97 score on a scale
Standard Deviation 8.10
|
10.08 score on a scale
Standard Deviation 7.23
|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
Difference at Visit 2 in comparison with Visit 1
|
-1.88 score on a scale
Standard Deviation 5.10
|
-1.11 score on a scale
Standard Deviation 5.54
|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
BAI scores at Visit 4
|
8.10 score on a scale
Standard Deviation 7.04
|
9.14 score on a scale
Standard Deviation 7.13
|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
Difference at Visit 4 in comparison with Visit 1
|
-3.77 score on a scale
Standard Deviation 5.09
|
-2.02 score on a scale
Standard Deviation 5.98
|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
BAI scores at Visit 5
|
7.07 score on a scale
Standard Deviation 6.42
|
8.90 score on a scale
Standard Deviation 7.15
|
|
Changes in the Anxiety Level According to the Beck Anxiety Inventory
Difference at Visit 5 in comparison with Visit 1
|
-4.70 score on a scale
Standard Deviation 5.49
|
-2.26 score on a scale
Standard Deviation 7.10
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The A.M.Wein's questionnaire is used between Visit 1 and Visit 2, 4, 5. It includes 11 main signs of autonomic disorders. Each autonomic symptom is assessed using scores from 7 to 3, then the scores are summed. Scores may range from 0 to 60, higher scores mean a worse outcome. The total sum of the scores in healthy individuals should be 0-14 scores. 15-29 scores are indicative of moderate vegetative dystonia syndrome, 30 and more scores are indicative of severe vegetative dystonia syndrome.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Wein's questionnaire, Visit 2
|
23.58 score on a scale
Standard Deviation 13.68
|
24.11 score on a scale
Standard Deviation 12.61
|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Difference at Visit 2 in comparison with Visit 1
|
-3.01 score on a scale
Standard Deviation 7.71
|
-2.18 score on a scale
Standard Deviation 8.01
|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Wein's questionnaire, Visit 4
|
21.37 score on a scale
Standard Deviation 13.80
|
22.89 score on a scale
Standard Deviation 12.61
|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Difference at Visit 4 in comparison with Visit 1
|
-5.23 score on a scale
Standard Deviation 9.19
|
-3.42 score on a scale
Standard Deviation 10.23
|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Wein's questionnaire, Visit 5
|
19.70 score on a scale
Standard Deviation 13.92
|
22.01 score on a scale
Standard Deviation 13.07
|
|
Autonomic Changes According to the A.M.Wein's Questionnaire
Difference at Visit 5 in comparison with Visit 1
|
-6.76 score on a scale
Standard Deviation 10.94
|
-4.30 score on a scale
Standard Deviation 10.81
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Digit Symbol Substitution Test is used between Visit 1 and Visits 2, 4, 5. The DSST is used to measure attention, processing speed and executive function. It is a pencil and paper test of psychomotor performance in which the subject is given a key grid of numbers and matching symbols and a test section with numbers and empty boxes. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved in 90 s. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
DSST, Visit 2
|
36.94 score on a scale
Standard Deviation 10.82
|
36.33 score on a scale
Standard Deviation 11.84
|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
Difference at Visit 2 in comparison with Visit 1
|
4.11 score on a scale
Standard Deviation 6.63
|
2.61 score on a scale
Standard Deviation 7.18
|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
DSST, Visit 4
|
39.80 score on a scale
Standard Deviation 10.78
|
37.89 score on a scale
Standard Deviation 11.78
|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
Difference at Visit 4 in comparison with Visit 1
|
6.91 score on a scale
Standard Deviation 8.10
|
4.24 score on a scale
Standard Deviation 8.77
|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
DSST, Visit 5
|
42.72 score on a scale
Standard Deviation 12.53
|
39.05 score on a scale
Standard Deviation 12.36
|
|
Changes in Cognitive Impairment Assessed With Digit Symbol Substitution Test
Difference at Visit 5 in comparison with Visit 1
|
9.84 score on a scale
Standard Deviation 10.50
|
5.40 score on a scale
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)Population: The efficacy analysis was performed for ITT-population excluding participant No. 098 whose data after the randomization visit are missing.
The Tinetti test is used between Visit 1 and Visits 2, 4, 5. The Tinetti test is a clinical test for the assessment of balance and gait. It has a gait score and a balance score using a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling. Tinetti test score equal or less than 18 shows high risk of fall, 19-23 scores show moderate risk of fall, and score equal or higher than 24 shows low risk of fall. Thus, min value is 0, max value is 28, higher scores mean a better outcome.
Outcome measures
| Measure |
Main (Mexidol)
n=159 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=158 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Motor Changes Assessed With the Tinetti Test
Tinetti test, Visit 2
|
34.26 score on a scale
Standard Deviation 4.92
|
34.00 score on a scale
Standard Deviation 4.75
|
|
Motor Changes Assessed With the Tinetti Test
Difference at Visit 2 in comparison with Visit 1
|
1.62 score on a scale
Standard Deviation 2.47
|
0.71 score on a scale
Standard Deviation 2.84
|
|
Motor Changes Assessed With the Tinetti Test
Tinetti test, Visit 4
|
35.06 score on a scale
Standard Deviation 4.57
|
34.39 score on a scale
Standard Deviation 4.47
|
|
Motor Changes Assessed With the Tinetti Test
Difference at Visit 4 in comparison with Visit 1
|
2.44 score on a scale
Standard Deviation 3.20
|
1.18 score on a scale
Standard Deviation 3.51
|
|
Motor Changes Assessed With the Tinetti Test
Tinetti test, Visit 5
|
35.97 score on a scale
Standard Deviation 4.26
|
34.75 score on a scale
Standard Deviation 4.42
|
|
Motor Changes Assessed With the Tinetti Test
Difference at Visit 5 in comparison with Visit 1
|
3.36 score on a scale
Standard Deviation 3.39
|
1.55 score on a scale
Standard Deviation 4.05
|
SECONDARY outcome
Timeframe: Day 75+2 (Visit 5)Population: The analysis was performed for the PP-population (312 participants).
The Clinical Global Impressions Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication. The interpretation of scores is as follows: 00 - Not assessed 01 - Vast improvement. Side effects - None. 03 - Vast improvement. Side effects - Significantly interfere with patient's therapeutic patient's functioning 04 - Vast improvement. Side effects - outweights therapeutic effect 05 - Decided improvement. Side effects - none 09 - Slight improvement. Side effects - none 10 - Slight improvement. Side effects - do not significantly interfere with patient's functioning 13 - Slight improvement. Side effects - none
Outcome measures
| Measure |
Main (Mexidol)
n=157 Participants
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=155 Participants
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
09
|
54 Participants
|
56 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
01
|
45 Participants
|
7 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
03
|
1 Participants
|
0 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
04
|
0 Participants
|
1 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
05
|
39 Participants
|
16 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
10
|
3 Participants
|
0 Participants
|
|
Change in Global Illness Severity Assessed With the Clinical Global Impressions Scale at Visit 5 Compared to Baseline Measure
13
|
15 Participants
|
75 Participants
|
Adverse Events
Main (Mexidol)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Control (Placebo)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Main (Mexidol)
n=159 participants at risk
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
Control (Placebo)
n=159 participants at risk
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.9%
3/159 • Number of events 3 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Itchy nose
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Itchy throat
|
2.5%
4/159 • Number of events 4 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Musculoskeletal and connective tissue disorders
Backache
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dysgeusia
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Nervous system disorders
Dizziness
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Leukocyturia
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Gastrointestinal disorders
Nausea
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Respiratory, thoracic and mediastinal disorders
Viral pneumonia
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Cardiac disorders
High blood pressure
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Investigations
High levels of alanine aminotransferase
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.9%
3/159 • Number of events 3 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Investigations
High levels of aspartate aminotransferase
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Investigations
High levels of blood creatinine
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Investigations
High levels of blood urea
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Musculoskeletal and connective tissue disorders
Limb pain
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
1.3%
2/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Hyperoxaluria
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Cardiac disorders
Right bundle branch block
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Cardiac disorders
Heart palpitation
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Vascular disorders
Hyperemia
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
General disorders
Burning sensation
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 2 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/159 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
0.63%
1/159 • Number of events 1 • From Day 1 (Visit 1) to Day 75+2 (Visit 5) or Early Termination Visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60