Trial Outcomes & Findings for Efficacy and Safety of Mexidol® in Stroke Therapy (NCT NCT06437626)
NCT ID: NCT06437626
Last Updated: 2025-12-30
Results Overview
The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline, Day 71
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Mexidol®
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
152
|
|
Overall Study
COMPLETED
|
141
|
138
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Mexidol® in Stroke Therapy
Baseline characteristics by cohort
| Measure |
Mexidol®
n=152 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=152 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.45 years
STANDARD_DEVIATION 7.88 • n=174 Participants
|
62.61 years
STANDARD_DEVIATION 7.49 • n=166 Participants
|
62.53 years
STANDARD_DEVIATION 7.68 • n=167 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=174 Participants
|
52 Participants
n=166 Participants
|
100 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=174 Participants
|
100 Participants
n=166 Participants
|
204 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=174 Participants
|
16 Participants
n=166 Participants
|
29 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
139 Participants
n=174 Participants
|
136 Participants
n=166 Participants
|
275 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Region of Enrollment
Uzbekistan
|
10 participants
n=174 Participants
|
10 participants
n=166 Participants
|
20 participants
n=167 Participants
|
|
Region of Enrollment
Kazakhstan
|
10 participants
n=174 Participants
|
10 participants
n=166 Participants
|
20 participants
n=167 Participants
|
|
Region of Enrollment
Russia
|
132 participants
n=174 Participants
|
132 participants
n=166 Participants
|
264 participants
n=167 Participants
|
|
Modified Rankin Scale (mRS)
|
3.90 units on a scale
STANDARD_DEVIATION 0.50 • n=174 Participants
|
3.94 units on a scale
STANDARD_DEVIATION 0.48 • n=166 Participants
|
3.92 units on a scale
STANDARD_DEVIATION 0.49 • n=167 Participants
|
|
Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability)
|
152 Participants
n=174 Participants
|
152 Participants
n=166 Participants
|
304 Participants
n=167 Participants
|
|
Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disa
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
National Institutes of Health Stroke Scale (NIHSS)
|
9 units on a scale
n=174 Participants
|
10 units on a scale
n=166 Participants
|
9.5 units on a scale
n=167 Participants
|
|
Rivermead Mobility Index (RMI)
|
3 units on a scale
n=174 Participants
|
3 units on a scale
n=166 Participants
|
3 units on a scale
n=167 Participants
|
|
Montreal Cognitive Assessment (MoCA test)
|
22 units on a scale
n=174 Participants
|
22 units on a scale
n=166 Participants
|
22 units on a scale
n=167 Participants
|
|
Hospital Anxiety and Depression Scale, domain ANXIETY (HADS-A)
|
6 units on a scale
n=174 Participants
|
5 units on a scale
n=166 Participants
|
5 units on a scale
n=167 Participants
|
|
Hospital Anxiety and Depression Scale, domain DEPRESSION (HADS-D)
|
6 units on a scale
n=174 Participants
|
5 units on a scale
n=166 Participants
|
5 units on a scale
n=167 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 71The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
Outcome measures
| Measure |
Mexidol®
n=141 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=138 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy
|
-2.45 score on a scale
Interval -2.7 to -2.23
|
-2.01 score on a scale
Interval -2.25 to -1.87
|
SECONDARY outcome
Timeframe: Day 71The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\].
Outcome measures
| Measure |
Mexidol®
n=141 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=138 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) at the End of the Course of Therapy
|
22 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 71The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\].
Outcome measures
| Measure |
Mexidol®
n=141 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=138 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disability) at the End of the Course of Therapy
|
85 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale.
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores).
Outcome measures
| Measure |
Mexidol®
n=139 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=137 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy
|
-7 score on a scale
Interval -9.0 to -6.0
|
-7 score on a scale
Interval -8.0 to -5.0
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale.
The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, walking, stair use, and running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility) \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Outcome measures
| Measure |
Mexidol®
n=139 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=137 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy
|
10 score on a scale
Interval 7.0 to 12.0
|
9 score on a scale
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale.
The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Outcome measures
| Measure |
Mexidol®
n=139 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=137 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy
|
4 score on a scale
Interval 2.0 to 6.0
|
3 score on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale.
The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded \[22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Outcome measures
| Measure |
Mexidol®
n=139 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=137 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain ANXIETY (HADS-A), at the End of the Course of Therapy
|
-2 score on a scale
Interval -5.0 to 0.0
|
-1 score on a scale
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 71Population: The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale.
The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded \[22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome\]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores).
Outcome measures
| Measure |
Mexidol®
n=139 Participants
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=137 Participants
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain DEPRESSION (HADS-D), at the End of the Course of Therapy
|
-2 score on a scale
Interval -4.0 to 0.0
|
-1 score on a scale
Interval -4.0 to 0.0
|
Adverse Events
Mexidol®
Serious events: 6 serious events
Other events: 36 other events
Deaths: 2 deaths
Placebo
Serious events: 4 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mexidol®
n=152 participants at risk
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=152 participants at risk
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Ischaemic stroke
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Brain oedema
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Cerebral infarction
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Pneumonia viral
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
COVID-19 pneumonia
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Number of events 1 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
COVID-19
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
2.0%
3/152 • Number of events 3 • Throughout the study [From Day 1 up to Day 71]
|
Other adverse events
| Measure |
Mexidol®
n=152 participants at risk
Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Mexidol: 50 mg/ml IV solution, 250 mg tablets
|
Placebo
n=152 participants at risk
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Latent syphilis
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Investigations
Blood pressure increased
|
2.0%
3/152 • Throughout the study [From Day 1 up to Day 71]
|
3.3%
5/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Investigations
Blood pressure decreased
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Investigations
Transaminases increased
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Metabolism and nutrition disorders
Cell death
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Headache
|
3.3%
5/152 • Throughout the study [From Day 1 up to Day 71]
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Muscular weakness
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Nervous system disorders
Carotid artery occlusion
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Cardiac disorders
Bradycardia
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Cardiac disorders
Palpitations
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Cardiac disorders
Tachycardia
|
2.0%
3/152 • Throughout the study [From Day 1 up to Day 71]
|
2.6%
4/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Pharyngitis
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
0.00%
0/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
1/152 • Throughout the study [From Day 1 up to Day 71]
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
|
Infections and infestations
COVID-19
|
2.0%
3/152 • Throughout the study [From Day 1 up to Day 71]
|
1.3%
2/152 • Throughout the study [From Day 1 up to Day 71]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place