Trial Outcomes & Findings for Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol) (NCT NCT05508074)
NCT ID: NCT05508074
Last Updated: 2025-10-10
Results Overview
* Incidence, grade and relationship to IFB-088 for treatment emergent AEs (TEAEs), SAEs, and AESIs, * AEs leading to dose interruption or premature discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
from beginning of IMP intake up to 30 days after stopping the intake, an average of 7 months
Results posted on
2025-10-10
Participant Flow
Participant milestones
| Measure |
Placebo + Riluzole 100 mg/Day
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
34
|
|
Overall Study
COMPLETED
|
14
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
Reasons for withdrawal
| Measure |
Placebo + Riluzole 100 mg/Day
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
wrongly randomized
|
0
|
1
|
|
Overall Study
non-compliance
|
0
|
1
|
Baseline Characteristics
Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)
Baseline characteristics by cohort
| Measure |
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
France
|
20 participants
n=5 Participants
|
8 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
BMI
|
24.49 kg/m^2
STANDARD_DEVIATION 3.60 • n=5 Participants
|
23.88 kg/m^2
STANDARD_DEVIATION 4.12 • n=7 Participants
|
24.29 kg/m^2
STANDARD_DEVIATION 3.75 • n=5 Participants
|
|
Tobacco smoking, n (%)
Missing data
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tobacco smoking, n (%)
No
|
30 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Tobacco smoking, n (%)
Yes
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from beginning of IMP intake up to 30 days after stopping the intake, an average of 7 months* Incidence, grade and relationship to IFB-088 for treatment emergent AEs (TEAEs), SAEs, and AESIs, * AEs leading to dose interruption or premature discontinuation.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE
|
10 Participants
|
25 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE related to study drug
|
4 Participants
|
13 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Serious TEAE
|
4 Participants
|
8 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Serious TEAE related to study drug
|
0 Participants
|
2 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Fatal TEAE
|
2 Participants
|
5 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Fatal TEAE related to study drug
|
0 Participants
|
2 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade 1 TEAE
|
7 Participants
|
19 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade 2 TEAE
|
5 Participants
|
11 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade > or = 3 TEAE
|
3 Participants
|
10 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade > or = 3 TEAE related to study drug
|
0 Participants
|
3 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade > or = 3 serious TEAE
|
2 Participants
|
8 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
Grade >or = 3 serious TEAE related to study drug
|
0 Participants
|
2 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE leading to temporary discontinuation of study drug
|
1 Participants
|
1 Participants
|
|
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE leading to definitive discontinuation of study drug
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Efficacy scale from baseline to V3 (3 months) and V4 (6 months).Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised) 12 items, clinician rated including 5 choices from normal to disabled. Maximal score: 48, minimal score: 0 (death)
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)
ALSFRS-R Baseline
|
43.9 score on a scale
Standard Deviation 2.1
|
42.2 score on a scale
Standard Deviation 2.7
|
|
Efficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)
ALSFRS-R V3 visit (3 months)
|
39.5 score on a scale
Standard Deviation 5.9
|
36.0 score on a scale
Standard Deviation 8.7
|
|
Efficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)
ALSFRS-R V4 visit (6 months)
|
34.7 score on a scale
Standard Deviation 11.0
|
36.1 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: baseline, V3 (3 months), V4 (6 months)Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
ALS\_MITOS (Amyotrophic Lateral Sclerosis Milano-Torino Staging) scale scores the total points of points given in 4 domains (movement, swallowing, communicating, breathing), clinician rated. The ALS8MITOS score is determined by the sum of functional score of 1 for each domain, up to 5, being death. The score may go from 0= no functionnal domain lost, up to 5=death (1 to 4 corresponding to the number of domains lost by the patient).
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)
Baseline
|
0 score on a scale
Standard Deviation 0
|
0.1 score on a scale
Standard Deviation 0.2
|
|
Efficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)
V3 visit
|
0.1 score on a scale
Standard Deviation 0.3
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Efficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)
V4 visit
|
0.6 score on a scale
Standard Deviation 1.2
|
0.3 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Efficacy scale from baseline to 3 months and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
King's college Scale (King's ALS staging form), clinician rated, 8 items. 0=best, 5=death
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy With Scale : King's College Scale (ALS Staging Form)
Baseline
|
1.6 score on a scale
Standard Deviation 0.8
|
2.1 score on a scale
Standard Deviation 0.8
|
|
Efficacy With Scale : King's College Scale (ALS Staging Form)
V3 visit
|
2.1 score on a scale
Standard Deviation 1.2
|
2.7 score on a scale
Standard Deviation 0.9
|
|
Efficacy With Scale : King's College Scale (ALS Staging Form)
V4 visit
|
2.8 score on a scale
Standard Deviation 1.4
|
3.0 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Respiratory function at screening, 3 and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...). SVC is a respiratory test hence patients suffering from ALS were not always able to perform the test.
Assessment of respiratory function (slow vital capacity \[SVC\]).
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])
Baseline
|
88.5 percentage of SVC
Standard Deviation 11.3
|
84.7 percentage of SVC
Standard Deviation 17.8
|
|
Efficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])
V3 visit
|
74.6 percentage of SVC
Standard Deviation 21.7
|
72.9 percentage of SVC
Standard Deviation 18.4
|
|
Efficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])
V4 visit
|
67.9 percentage of SVC
Standard Deviation 18.4
|
69.8 percentage of SVC
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Respiratory function at screening, 3 and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PaCO2 (mmHg), at screening, 3 and 6 months.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)
PaCO2 baseline
|
37.8 millimeters of Mercury
Standard Deviation 4.0
|
38.5 millimeters of Mercury
Standard Deviation 4.5
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)
PaCO2 V3 Visit
|
38.0 millimeters of Mercury
Standard Deviation 3.9
|
39.5 millimeters of Mercury
Standard Deviation 4.3
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)
PaCO2 V4 visit
|
38.7 millimeters of Mercury
Standard Deviation 3.7
|
38.0 millimeters of Mercury
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: At baseline and 6 monthschange of body composition (% of water, muscle, bone in the body) evaluated by bioelectrical impedance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng.h/mL.
Area Under the Curve (AUC (0-12h)) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng.h/mL.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (Area Under Curve [AUC])
IFB-088
|
63 ng.h/mL
Geometric Coefficient of Variation 61
|
0 ng.h/mL
Geometric Coefficient of Variation 0
|
|
Pharmacokinetic Parameters (Area Under Curve [AUC])
IFB-139 (metabolite)
|
69 ng.h/mL
Geometric Coefficient of Variation 48.9
|
0 ng.h/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng/mL.
Maximum observed plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng/mL.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (Cmax)
IFB-088
|
12 ng/mL
Geometric Coefficient of Variation 66.4
|
0 ng/mL
Geometric Coefficient of Variation 0
|
|
Pharmacokinetic Parameters (Cmax)
IFB-139 (metabolite)
|
12 ng/mL
Geometric Coefficient of Variation 45.9
|
0 ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h.
Time at which maximum plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139 is measured As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (Tmax)
IFB-088
|
1.0 h
Interval 1.0 to 4.0
|
0 h
Interval 0.0 to 0.0
|
|
Pharmacokinetic Parameters (Tmax)
IFB-139 (metabolite)
|
1.0 h
Interval 1.0 to 4.0
|
0 h
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h.
Terminal or apparent terminal half-life (t1/2) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (t1/2)
IFB-088
|
4.62 h
Geometric Coefficient of Variation 40.5
|
0 h
Geometric Coefficient of Variation 0
|
|
Pharmacokinetic Parameters (t1/2)
IFB-139 (metabolite)
|
7.9 h
Geometric Coefficient of Variation 35.4
|
0 h
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L/h.
IFB-088 Apparent systemic clearance calculation (CL/F) As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L/h.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (Clearance)
|
580 L/h
Geometric Coefficient of Variation 73.0
|
0 L/h
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: PK parameters will be analysed after 4 weeks of treatment.Population: As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L.
IFB-088 Apparent volume of distribution (Vd). As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Pharmacokinetic Parameters (Vd)
|
3722 L
Geometric Coefficient of Variation 57.9
|
0 L
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: At baseline and 6 months.Change in TDP-43 plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Change in neurofilament (NfL) light chain plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Biomarkers (Neurofilament Light Chain)
Baseline
|
86.57 pg/mL
Interval 74.6 to 100.45
|
65.29 pg/mL
Interval 50.73 to 84.02
|
|
Biomarkers (Neurofilament Light Chain)
V4 visit
|
92.91 pg/mL
Interval 76.51 to 112.34
|
76.19 pg/mL
Interval 61.95 to 93.7
|
SECONDARY outcome
Timeframe: All assessed at baseline and V4 visit (6 months). Only GDF15, MCP1, BDNF, and TGFb1 also assessed at V3 visit (3 months)Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Inflammation biomarkers (interleukin \[IL\]-6, tumour necrosis factor-α \[TNFα\], interferon γ \[IFNγ\], IL-1β, IL-8, IL-10, monocyte chemoattractant protein-1 \[MCP-1\], nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\], vascular endothelial growth factor \[VEGF\]): (concentration of each biomarker in ng/mL, technology Luminex®)).
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Biomarkers (Inflammation Biomarkers)
GDF15 baseline
|
704.26 ng/mL
Interval 565.6 to 876.93
|
580.31 ng/mL
Interval 437.58 to 769.61
|
|
Biomarkers (Inflammation Biomarkers)
GDF15 V3 visit
|
711.31 ng/mL
Interval 556.9 to 908.54
|
572.30 ng/mL
Interval 421.0 to 777.98
|
|
Biomarkers (Inflammation Biomarkers)
GDF15 V4 visit
|
704.90 ng/mL
Interval 541.44 to 917.7
|
580.13 ng/mL
Interval 445.1 to 756.11
|
|
Biomarkers (Inflammation Biomarkers)
MCP1 baseline
|
168.00 ng/mL
Interval 146.12 to 193.16
|
149.61 ng/mL
Interval 117.08 to 191.17
|
|
Biomarkers (Inflammation Biomarkers)
MCP1 V3 visit
|
163.47 ng/mL
Interval 137.89 to 193.79
|
131.92 ng/mL
Interval 107.57 to 161.78
|
|
Biomarkers (Inflammation Biomarkers)
MCP1 V4 visit
|
171.21 ng/mL
Interval 145.78 to 201.06
|
127.53 ng/mL
Interval 100.29 to 162.18
|
|
Biomarkers (Inflammation Biomarkers)
BDNF baseline
|
2348.36 ng/mL
Interval 1768.3 to 3118.7
|
2717.82 ng/mL
Interval 1687.3 to 4377.72
|
|
Biomarkers (Inflammation Biomarkers)
BDNF V3 visit
|
1892.51 ng/mL
Interval 1364.3 to 2625.23
|
2277.30 ng/mL
Interval 1221.31 to 4246.35
|
|
Biomarkers (Inflammation Biomarkers)
BDNF V4 visit
|
1777.28 ng/mL
Interval 1208.59 to 2613.55
|
2717.49 ng/mL
Interval 1673.06 to 4413.92
|
|
Biomarkers (Inflammation Biomarkers)
TGFb1 baseline
|
30524.88 ng/mL
Interval 24598.01 to 37879.82
|
34174.62 ng/mL
Interval 23139.56 to 50472.23
|
|
Biomarkers (Inflammation Biomarkers)
TGFb1 V3 visit
|
25955.30 ng/mL
Interval 20552.48 to 32778.39
|
28333.44 ng/mL
Interval 18658.68 to 43024.7
|
|
Biomarkers (Inflammation Biomarkers)
TGFb1 V4 visit
|
20906.55 ng/mL
Interval 15906.89 to 27477.63
|
37702.08 ng/mL
Interval 26739.69 to 53158.68
|
|
Biomarkers (Inflammation Biomarkers)
8-OxoDG baseline
|
203.01 ng/mL
Interval 173.78 to 237.15
|
175.29 ng/mL
Interval 142.6 to 215.49
|
|
Biomarkers (Inflammation Biomarkers)
8-OxoDG V4 visit
|
220.68 ng/mL
Interval 187.12 to 260.27
|
215.11 ng/mL
Interval 159.73 to 289.69
|
|
Biomarkers (Inflammation Biomarkers)
FGF21 baseline
|
302.11 ng/mL
Interval 187.86 to 485.85
|
274.81 ng/mL
Interval 144.29 to 523.4
|
|
Biomarkers (Inflammation Biomarkers)
FGF21 V4 visit
|
230.51 ng/mL
Interval 129.51 to 410.28
|
298.73 ng/mL
Interval 163.68 to 545.22
|
|
Biomarkers (Inflammation Biomarkers)
NGFR/p75ECD baseline
|
5143.46 ng/mL
Interval 4135.27 to 6397.47
|
4281.16 ng/mL
Interval 2994.38 to 6120.91
|
|
Biomarkers (Inflammation Biomarkers)
NGFR/p75ECD V4 visit
|
6675.13 ng/mL
Interval 5401.43 to 8249.19
|
6108.71 ng/mL
Interval 4569.22 to 8166.9
|
|
Biomarkers (Inflammation Biomarkers)
IL-6 baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL-6 V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
TNFa baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
TNFa V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IFNg baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IFNg V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL1b baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL1b V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL8 baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL8 V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL10 baseline
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
|
Biomarkers (Inflammation Biomarkers)
IL10 V4 visit
|
NA ng/mL
below the limit of detection
|
NA ng/mL
below the limit of detection
|
SECONDARY outcome
Timeframe: At baseline, 3 months, and 6 months.3-Nitrotyrosine (Oxidative stress biomarker): at baseline, 3 and 6 months (concentration in ng/mL, ELISA method).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: QoL will be assessed from baseline to 6 monthsPopulation: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Change in ALS assessment questionnaire (ALSAQ-40). ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire) Quality of Life questionnaire 40 items, patient rated including 5 choices from never to always. best=0, worse=100
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Quality of Life With ALSAQ-40 (ALS Assessment Questionnaire)
Baseline
|
40.7 score on a scale
Standard Deviation 20.5
|
39.5 score on a scale
Standard Deviation 22.3
|
|
Quality of Life With ALSAQ-40 (ALS Assessment Questionnaire)
V4 visit
|
67.1 score on a scale
Standard Deviation 31.3
|
61.4 score on a scale
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: Respiratory function at screening, 3 and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PO2 (mmHg) at screening, 3 and 6 months.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)
PaO2 baseline
|
88.8 millimeters of Mercury
Standard Deviation 16.8
|
97.5 millimeters of Mercury
Standard Deviation 25.8
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)
PaO2 V3 Visit
|
97.4 millimeters of Mercury
Standard Deviation 24.5
|
89.1 millimeters of Mercury
Standard Deviation 14.1
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)
PaO2 V4 Visit
|
91.6 millimeters of Mercury
Standard Deviation 12.6
|
93.3 millimeters of Mercury
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Respiratory function at screening, 3 and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of HCO3 (mEq/L) at screening, 3 and 6 months.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)
HCO3 baseline
|
24.7 mEq/L (HCO3)
Standard Deviation 1.9
|
24.8 mEq/L (HCO3)
Standard Deviation 1.9
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)
HCO3 V3 visit
|
24.8 mEq/L (HCO3)
Standard Deviation 2.2
|
24.8 mEq/L (HCO3)
Standard Deviation 2.7
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)
HCO3 V4 visit
|
25.5 mEq/L (HCO3)
Standard Deviation 2.6
|
24.6 mEq/L (HCO3)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Respiratory function at screening, 3 and 6 months.Population: The presented data are on the Full Analysis Set (FAS), in which the number of patients changed over time as some patients were lost between baseline and V3 or V4 (death, consent withdrawal, ...).
Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of Oxygen saturation (%) at screening, 3 and 6 months.
Outcome measures
| Measure |
Placebo + Riluzole 100 mg/Day
n=34 Participants
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=17 Participants
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)
O2 saturation baseline
|
96 % (O2 sat)
Standard Deviation 2.5
|
96.9 % (O2 sat)
Standard Deviation 1.7
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)
O2 saturation V3 visit
|
95.2 % (O2 sat)
Standard Deviation 6.0
|
96.3 % (O2 sat)
Standard Deviation 2.1
|
|
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)
O2 stauration V4 visit
|
96.7 % (O2 sat)
Standard Deviation 1.7
|
96.6 % (O2 sat)
Standard Deviation 2.2
|
Adverse Events
Placebo + Riluzole 100 mg/Day
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
IFB-088 50 mg/Day + Riluzole 100 mg/Day
Serious events: 8 serious events
Other events: 25 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 participants at risk
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 participants at risk
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Infections and infestations
COVID 19
|
5.9%
1/17 • Number of events 4 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
Pneumonia aspiration
|
5.9%
1/17 • Number of events 4 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
Pneumonia viral
|
5.9%
1/17 • Number of events 4 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
1/17 • Number of events 4 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
cardio-respiratory arrest
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
General disorders
disease progression
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Surgical and medical procedures
hospitalisation
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 8 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
Other adverse events
| Measure |
Placebo + Riluzole 100 mg/Day
n=17 participants at risk
The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
Placebo: Placebo
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
IFB-088 50 mg/Day + Riluzole 100 mg/Day
n=34 participants at risk
The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg.
Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition.
Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs.
Patients will be treated for a period of 6 months (26 weeks).
IFB-088 50mg/day: Tested product
Riluzole 100mg/day: Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
erythema
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
23.5%
8/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
clavicle fracture
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
eschar
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
joint injury
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
periorbital haematoma
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
procedural dizziness
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Injury, poisoning and procedural complications
skin injury
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
11.8%
2/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
hypercapnia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
lower respiratory tract congestion
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
lung disorder
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
orthopnoea
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
COVID-19
|
11.8%
2/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
8.8%
3/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
Oral fungal infection
|
11.8%
2/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
bronchitis
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
urinary tract infection
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
bronchitis fungal
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
cystitis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
device related sepsis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
diverticulitis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
influenza
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
pneumonia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
pneumonia aspiration
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
pneumonia viral
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
respiratory tract infection
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Infections and infestations
sebaceous gland infection
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
8.8%
3/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
8.8%
3/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Gastrointestinal disorders
reflux gastritis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Vascular disorders
hypertension
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
5.9%
2/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Renal and urinary disorders
flank pain
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Renal and urinary disorders
pollakiuria
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Psychiatric disorders
anxiety
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Psychiatric disorders
depression
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Psychiatric disorders
mood altered
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
General disorders
asthenia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
General disorders
disease progression
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
General disorders
pyrexia
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
bradycardia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Cardiac disorders
cardia-respiratory arrest
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Musculoskeletal and connective tissue disorders
exostosis
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Musculoskeletal and connective tissue disorders
spinal pain
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Surgical and medical procedures
gastrostomy
|
11.8%
2/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Surgical and medical procedures
cataract operation
|
5.9%
1/17 • Number of events 10 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
0.00%
0/34 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Surgical and medical procedures
hospitalisation
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.00%
0/17 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
2.9%
1/34 • Number of events 25 • 7 months, from inclusion to last patient visit, one month after 6 months treatment ending
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place