Trial Outcomes & Findings for Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS (NCT NCT00868166)
NCT ID: NCT00868166
Last Updated: 2020-02-25
Results Overview
Overall survival was defined from the date of randomization until the date of death (event) or last known alive date (censored). If the death date was after 18 months, the participant was censored at 18 months (548 days). Participants still alive at or after 18 months were censored at 18 months/ 548 days. All data over the 18-month follow-up period after randomization, and participant survival status at the 18-month follow-up visit for participants who withdrew prematurely from the study for reasons other than death were included.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
512 participants
Primary outcome timeframe
From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
Olesoxime
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Overall Study
STARTED
|
259
|
253
|
|
Overall Study
COMPLETED
|
147
|
139
|
|
Overall Study
NOT COMPLETED
|
112
|
114
|
Reasons for withdrawal
| Measure |
Olesoxime
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Overall Study
Death
|
58
|
65
|
|
Overall Study
Withdrawal by Subject
|
33
|
25
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Adverse Event
|
9
|
10
|
|
Overall Study
Lack of efficacy, logistics, unwell
|
9
|
10
|
|
Overall Study
Non-compliance with IMP
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
Baseline characteristics by cohort
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
Total
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
113 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Overall survival was defined from the date of randomization until the date of death (event) or last known alive date (censored). If the death date was after 18 months, the participant was censored at 18 months (548 days). Participants still alive at or after 18 months were censored at 18 months/ 548 days. All data over the 18-month follow-up period after randomization, and participant survival status at the 18-month follow-up visit for participants who withdrew prematurely from the study for reasons other than death were included.
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Overall Survival Rate at 18 Months
|
67.5 percentage of partcipants
Interval 61.0 to 73.1
|
69.4 percentage of partcipants
Interval 63.0 to 74.9
|
SECONDARY outcome
Timeframe: From randomization to the time of the first event to consider at 18 months (548 days)Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Time to failure was defined as the time from randomization to the time of the first event to consider (Tracheostomy, invasive ventilation \[IV\] or non invasive ventilation \[NIV\])
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Percentage of Participants With Failure Over 18 Months
|
67.1 percentage of participants
Interval 60.5 to 72.7
|
65.5 percentage of participants
Interval 59.1 to 71.2
|
SECONDARY outcome
Timeframe: Inclusion, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Inclusion
|
39.1 score on a scale
Standard Deviation 4.78
|
38.2 score on a scale
Standard Deviation 5.25
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 1
|
38.2 score on a scale
Standard Deviation 5.46
|
37.2 score on a scale
Standard Deviation 5.59
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 2
|
37.6 score on a scale
Standard Deviation 5.64
|
36.7 score on a scale
Standard Deviation 6.02
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 3
|
36.4 score on a scale
Standard Deviation 6.29
|
35.3 score on a scale
Standard Deviation 6.62
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 6
|
34.3 score on a scale
Standard Deviation 7.11
|
33.1 score on a scale
Standard Deviation 7.62
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 9
|
32.7 score on a scale
Standard Deviation 7.72
|
30.4 score on a scale
Standard Deviation 8.23
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 12
|
30.5 score on a scale
Standard Deviation 8.34
|
28.8 score on a scale
Standard Deviation 8.47
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 15
|
28.6 score on a scale
Standard Deviation 8.56
|
27.6 score on a scale
Standard Deviation 8.92
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Month 18
|
27.0 score on a scale
Standard Deviation 9.38
|
26.3 score on a scale
Standard Deviation 9.13
|
SECONDARY outcome
Timeframe: Month 18 (548 days)Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Percentage of participants with a global ALS FRS-R score of \< 30 or death was estimated using the Kaplan-Meier method in the ITT, with a two-tailed log-rank, both stratified by site of onset (bulbar or spinal) and non-stratified. The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Percentage of Participants With a Global ALS FRS-R Score of <30 or Death
|
28.2 percentage of participants
Interval 22.5 to 34.1
|
24.9 percentage of participants
Interval 19.2 to 30.8
|
SECONDARY outcome
Timeframe: Baseline, Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated at specified time points.
SVC as a percent of the predicted value was evaluated and reported.
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Slow Vital Capacity (SVC) Percent Predicted
Baseline
|
93.1 percentage (%)
Standard Deviation 14.6
|
93.1 percentage (%)
Standard Deviation 15.4
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 1
|
89.7 percentage (%)
Standard Deviation 17.8
|
89.7 percentage (%)
Standard Deviation 17.6
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 3
|
84.8 percentage (%)
Standard Deviation 20.4
|
85.7 percentage (%)
Standard Deviation 19.7
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 6
|
80.7 percentage (%)
Standard Deviation 22.9
|
80.5 percentage (%)
Standard Deviation 22.5
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 9
|
77.9 percentage (%)
Standard Deviation 24.3
|
75.5 percentage (%)
Standard Deviation 24.7
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 12
|
74.5 percentage (%)
Standard Deviation 25.4
|
71.3 percentage (%)
Standard Deviation 29.0
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 15
|
70.5 percentage (%)
Standard Deviation 28.8
|
71.4 percentage (%)
Standard Deviation 27.1
|
|
Slow Vital Capacity (SVC) Percent Predicted
Month 18
|
69.0 percentage (%)
Standard Deviation 27.6
|
67.1 percentage (%)
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Month 18 (548 days)Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for specified analysis.
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Percentage of Participants With SVC Percent Predicted <70% or Had Died Over 18 Months
|
28.9 percentage of participants
Interval 23.0 to 35.1
|
31.9 percentage of participants
Interval 25.6 to 38.4
|
SECONDARY outcome
Timeframe: Inclusion, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
MMT score involved the examination of 30 items. These 30 items are scored from 0 (no trace of contraction) to 5 (normal power at first try). The global score is the sum of the item scores and can range from 0 to 150. Higher score indicates some power.
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Inclusion
|
128 score on a scale
Standard Deviation 18.0
|
126 score on a scale
Standard Deviation 18.8
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 3
|
121 score on a scale
Standard Deviation 22.8
|
120 score on a scale
Standard Deviation 22.0
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 6
|
117 score on a scale
Standard Deviation 24.4
|
114 score on a scale
Standard Deviation 24.6
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 9
|
112 score on a scale
Standard Deviation 27.1
|
109 score on a scale
Standard Deviation 27.1
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 12
|
106 score on a scale
Standard Deviation 29.7
|
103 score on a scale
Standard Deviation 29.6
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 15
|
101 score on a scale
Standard Deviation 32.0
|
99.2 score on a scale
Standard Deviation 31.2
|
|
Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Month 18
|
95.2 score on a scale
Standard Deviation 33.7
|
91.8 score on a scale
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18Population: ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
The single-item McGill quality of life scale evaluated the following question "Considering all parts of my life - physical, emotional, social, spiritual, and financial - over the past two (2) days, the quality of my life has been…"as a score of 1 to 10 on a visual analog scale where 0 is very bad and 10 is excellent.
Outcome measures
| Measure |
Olesoxime
n=259 Participants
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 Participants
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
The Single-Item Mc Gill Quality of Life Scale
Inclusion
|
6.51 score on a scale
Standard Deviation 1.65
|
6.47 score on a scale
Standard Deviation 1.65
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 1
|
6.17 score on a scale
Standard Deviation 1.73
|
6.27 score on a scale
Standard Deviation 1.78
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 3
|
5.83 score on a scale
Standard Deviation 1.98
|
5.75 score on a scale
Standard Deviation 1.89
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 6
|
5.55 score on a scale
Standard Deviation 2.12
|
5.50 score on a scale
Standard Deviation 2.00
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 9
|
5.30 score on a scale
Standard Deviation 2.14
|
5.25 score on a scale
Standard Deviation 2.00
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 12
|
4.97 score on a scale
Standard Deviation 2.11
|
5.10 score on a scale
Standard Deviation 2.02
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 15
|
4.96 score on a scale
Standard Deviation 2.26
|
4.90 score on a scale
Standard Deviation 2.13
|
|
The Single-Item Mc Gill Quality of Life Scale
Month 18
|
4.77 score on a scale
Standard Deviation 2.29
|
5.01 score on a scale
Standard Deviation 2.16
|
Adverse Events
Olesoxime
Serious events: 68 serious events
Other events: 98 other events
Deaths: 79 deaths
Placebo Comparator
Serious events: 65 serious events
Other events: 101 other events
Deaths: 80 deaths
Serious adverse events
| Measure |
Olesoxime
n=259 participants at risk
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 participants at risk
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.4%
14/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
3.2%
8/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
8/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
2.8%
7/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
5/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
2.4%
6/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
3/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
2.0%
5/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.5%
4/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.77%
2/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Pneumonia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
2.0%
5/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Lobar pneumonia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
1.2%
3/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Lung infection
|
0.77%
2/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Parotitis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Post procedural infection
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
4/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Nausea
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
3/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Circulatory collapse
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Embolism
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Thrombophlebitis
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Areflexia
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Cerebral haematoma
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Hypercapnic encephalopathy
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Meningorrhagia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Cardiac disorders
Sinus tachycardia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Application site inflammation
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Application site pain
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Death
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Fatigue
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
General physical health deterioration
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Pain
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
General disorders
Sudden death
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Psychiatric disorders
Anxiety
|
1.2%
3/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Psychiatric disorders
Depression
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
2/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.77%
2/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.79%
2/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Renal and urinary disorders
Renal colic
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Investigations
Aspartate aminotransferase increased
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Investigations
Hepatic enzyme increased
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Investigations
Troponin increased
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Surgical and medical procedures
Mechanical ventilation
|
0.77%
2/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.39%
1/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.00%
0/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
0.40%
1/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
Other adverse events
| Measure |
Olesoxime
n=259 participants at risk
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.
Riluzole: Riluzole given as add-on therapy 50mg bid.
|
Placebo Comparator
n=253 participants at risk
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
27/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
5.9%
15/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
15/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
6.3%
16/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Bronchitis
|
3.9%
10/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
5.9%
15/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
22/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
14.2%
36/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
26/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
7.5%
19/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Nervous system disorders
Headache
|
7.3%
19/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
7.1%
18/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
7/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
5.9%
15/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
|
Vascular disorders
Hypertension
|
2.7%
7/259 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
5.1%
13/253 • Safety was assessed during the 18-months study duration.
Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60