Trial Outcomes & Findings for HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262 (NCT NCT05740813)
NCT ID: NCT05740813
Last Updated: 2025-11-14
Results Overview
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each of 12 questions assessing distinct functional ability is scored from 4(normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function. Note that only participants who survived to their Week 24 visit contribute to the estimate.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
310 participants
Primary outcome timeframe
Baseline to 24 Weeks
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
ABBV-CLS-7262 Dose 1
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
79
|
76
|
|
Overall Study
COMPLETED
|
137
|
66
|
71
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed in row differs from overall number due to missing data.
Baseline characteristics by cohort
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=79 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=76 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 11.2 • n=155 Participants
|
58.2 Years
STANDARD_DEVIATION 11.02 • n=79 Participants
|
58.0 Years
STANDARD_DEVIATION 11.13 • n=76 Participants
|
57.7 Years
STANDARD_DEVIATION 11.11 • n=310 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=155 Participants
|
30 Participants
n=79 Participants
|
34 Participants
n=76 Participants
|
124 Participants
n=310 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=155 Participants
|
49 Participants
n=79 Participants
|
42 Participants
n=76 Participants
|
186 Participants
n=310 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=155 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=155 Participants
|
1 Participants
n=79 Participants
|
5 Participants
n=76 Participants
|
10 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=155 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=155 Participants
|
0 Participants
n=79 Participants
|
3 Participants
n=76 Participants
|
6 Participants
n=310 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=155 Participants
|
75 Participants
n=79 Participants
|
65 Participants
n=76 Participants
|
285 Participants
n=310 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=155 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=155 Participants
|
2 Participants
n=79 Participants
|
3 Participants
n=76 Participants
|
8 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=155 Participants
|
8 Participants
n=79 Participants
|
6 Participants
n=76 Participants
|
26 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
143 Participants
n=155 Participants
|
71 Participants
n=79 Participants
|
70 Participants
n=76 Participants
|
284 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=155 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=310 Participants
|
|
ALS Diagnosis from R El Escorial Criteria
Clinically Possible ALS
|
17 Participants
n=155 Participants
|
7 Participants
n=79 Participants
|
7 Participants
n=76 Participants
|
31 Participants
n=310 Participants
|
|
ALS Onset Location
Respiratory
|
2 Participants
n=155 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=310 Participants
|
|
ALS Diagnosis from R El Escorial Criteria
Clinically Probable ALS - Laboratory Supported
|
34 Participants
n=155 Participants
|
10 Participants
n=79 Participants
|
14 Participants
n=76 Participants
|
58 Participants
n=310 Participants
|
|
ALS Diagnosis from R El Escorial Criteria
Clinically Probable ALS
|
58 Participants
n=155 Participants
|
28 Participants
n=79 Participants
|
33 Participants
n=76 Participants
|
119 Participants
n=310 Participants
|
|
ALS Diagnosis from R El Escorial Criteria
Clinically Definite ALS
|
46 Participants
n=155 Participants
|
34 Participants
n=79 Participants
|
22 Participants
n=76 Participants
|
102 Participants
n=310 Participants
|
|
ALS Onset Location
Axial
|
0 Participants
n=155 Participants
|
2 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=310 Participants
|
|
ALS Onset Location
Bulbar
|
27 Participants
n=155 Participants
|
8 Participants
n=79 Participants
|
11 Participants
n=76 Participants
|
46 Participants
n=310 Participants
|
|
ALS Onset Location
Generalized
|
0 Participants
n=155 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=310 Participants
|
|
ALS Onset Location
Limb
|
125 Participants
n=155 Participants
|
67 Participants
n=79 Participants
|
65 Participants
n=76 Participants
|
257 Participants
n=310 Participants
|
|
ALS Onset Location
Multiple
|
1 Participants
n=155 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=76 Participants
|
2 Participants
n=310 Participants
|
|
Time Since Symptom Onset at Baseline
|
22.2 Months
STANDARD_DEVIATION 8.07 • n=155 Participants
|
19.6 Months
STANDARD_DEVIATION 7.94 • n=79 Participants
|
19.7 Months
STANDARD_DEVIATION 7.38 • n=76 Participants
|
20.93 Months
STANDARD_DEVIATION 7.95 • n=310 Participants
|
|
Delay in ALS Symptom Onset and Diagnosis
|
10.4 Months
STANDARD_DEVIATION 5.56 • n=155 Participants
|
9.3 Months
STANDARD_DEVIATION 5.44 • n=79 Participants
|
8.9 Months
STANDARD_DEVIATION 4.74 • n=76 Participants
|
9.71 Months
STANDARD_DEVIATION 5.36 • n=310 Participants
|
|
Baseline Edaravone Use
Yes
|
96 Participants
n=155 Participants
|
49 Participants
n=79 Participants
|
46 Participants
n=76 Participants
|
191 Participants
n=310 Participants
|
|
Baseline Edaravone Use
No
|
59 Participants
n=155 Participants
|
30 Participants
n=79 Participants
|
30 Participants
n=76 Participants
|
119 Participants
n=310 Participants
|
|
Baseline Riluzole Use
Yes
|
133 Participants
n=155 Participants
|
68 Participants
n=79 Participants
|
65 Participants
n=76 Participants
|
266 Participants
n=310 Participants
|
|
Baseline Riluzole Use
No
|
22 Participants
n=155 Participants
|
11 Participants
n=79 Participants
|
11 Participants
n=76 Participants
|
44 Participants
n=310 Participants
|
|
Baseline Relyvrio Use
Yes
|
90 Participants
n=155 Participants
|
47 Participants
n=79 Participants
|
46 Participants
n=76 Participants
|
183 Participants
n=310 Participants
|
|
Baseline Relyvrio Use
No
|
65 Participants
n=155 Participants
|
32 Participants
n=79 Participants
|
30 Participants
n=76 Participants
|
127 Participants
n=310 Participants
|
|
ALSFRS-R Total Score
|
36 Points
STANDARD_DEVIATION 6.54 • n=155 Participants
|
35 Points
STANDARD_DEVIATION 7.67 • n=79 Participants
|
36.8 Points
STANDARD_DEVIATION 6.68 • n=76 Participants
|
35.90 Points
STANDARD_DEVIATION 6.89 • n=310 Participants
|
|
Pre-Baseline Decline in ALSFRS-R
|
0.6 Points per Month
STANDARD_DEVIATION 0.44 • n=155 Participants
|
0.8 Points per Month
STANDARD_DEVIATION 0.66 • n=79 Participants
|
0.6 Points per Month
STANDARD_DEVIATION 0.41 • n=76 Participants
|
0.65 Points per Month
STANDARD_DEVIATION 0.51 • n=310 Participants
|
|
SVC
|
81.5 Percent predicted
STANDARD_DEVIATION 18.31 • n=155 Participants
|
82.0 Percent predicted
STANDARD_DEVIATION 17.20 • n=79 Participants
|
85.0 Percent predicted
STANDARD_DEVIATION 16.98 • n=76 Participants
|
82.51 Percent predicted
STANDARD_DEVIATION 17.72 • n=310 Participants
|
|
King Stage
1 Region with Neuromuscular Dysfunction
|
33 Participants
n=155 Participants
|
18 Participants
n=79 Participants
|
20 Participants
n=76 Participants
|
71 Participants
n=310 Participants
|
|
King Stage
2 Region with Neuromuscular Dysfunction
|
37 Participants
n=155 Participants
|
17 Participants
n=79 Participants
|
20 Participants
n=76 Participants
|
74 Participants
n=310 Participants
|
|
King Stage
3 Region with Neuromuscular Dysfunction;
|
40 Participants
n=155 Participants
|
19 Participants
n=79 Participants
|
22 Participants
n=76 Participants
|
81 Participants
n=310 Participants
|
|
King Stage
4a/b Nutritional/Respiratory Failure
|
45 Participants
n=155 Participants
|
25 Participants
n=79 Participants
|
14 Participants
n=76 Participants
|
84 Participants
n=310 Participants
|
|
Weight
|
82.4 Kg
STANDARD_DEVIATION 22.34 • n=155 Participants
|
78.8 Kg
STANDARD_DEVIATION 16.68 • n=79 Participants
|
81.1 Kg
STANDARD_DEVIATION 19.74 • n=76 Participants
|
81.19 Kg
STANDARD_DEVIATION 20.39 • n=310 Participants
|
|
Body Mass Index
|
27.4 kg/m^2
STANDARD_DEVIATION 6.53 • n=155 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.77 • n=79 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 5.33 • n=76 Participants
|
27.12 kg/m^2
STANDARD_DEVIATION 5.83 • n=310 Participants
|
|
Serum NfL Concentration
|
52.9 ng/L
n=150 Participants • Number analyzed in row differs from overall number due to missing data.
|
55.2 ng/L
n=76 Participants • Number analyzed in row differs from overall number due to missing data.
|
64.4 ng/L
n=69 Participants • Number analyzed in row differs from overall number due to missing data.
|
54.8 ng/L
n=295 Participants • Number analyzed in row differs from overall number due to missing data.
|
|
Serum Creatinine Concentration
|
0.7 mg/dL
STANDARD_DEVIATION 0.18 • n=155 Participants
|
0.7 mg/dL
STANDARD_DEVIATION 0.18 • n=79 Participants
|
0.7 mg/dL
STANDARD_DEVIATION 0.20 • n=76 Participants
|
0.7 mg/dL
STANDARD_DEVIATION 0.19 • n=310 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each of 12 questions assessing distinct functional ability is scored from 4(normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function. Note that only participants who survived to their Week 24 visit contribute to the estimate.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Disease Progression as Assessed by the ALSFRS-R-Slope
|
-1.00 Points per month
Standard Deviation 0.068
|
-0.91 Points per month
Standard Deviation 0.078
|
-0.95 Points per month
Standard Deviation 0.085
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Mortality Event Rate
|
0.009 Events per month
Standard Deviation 0.0022
|
0.008 Events per month
Standard Deviation 0.0021
|
0.009 Events per month
Standard Deviation 0.0022
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change from baseline to Week 24 in function as assessed by ALSFRS-R total score.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Function by ALSFRS-R Total Score
|
-6.110 Points
Standard Error 0.3710
|
-5.468 Points
Standard Error 0.5252
|
-5.563 Points
Standard Error 0.4106
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Respiratory Function
|
-10.882 24-week diff. of percents of normal VC
Standard Error 1.3311
|
-7.202 24-week diff. of percents of normal VC
Standard Error 1.9469
|
-9.462 24-week diff. of percents of normal VC
Standard Error 1.5259
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change in upper limb muscle strength over time as measured isometrically using hand-held dynamometry and grip strength, calculated as the average percent change from baseline of the following muscles/maneuvers: shoulder flexion, elbow flexion, elbow extension, wrist extension, abductor pollicis brevis contraction, abductor digiti minimi contraction, first dorsal interosseous contraction, and grip strength. Note that only those with measurable strength at baseline were included.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Upper Limb Muscle Strength
|
-36.281 Percent change
Standard Error 2.6896
|
-25.760 Percent change
Standard Error 3.8365
|
-38.078 Percent change
Standard Error 3.0500
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change in log-transformed serum neurofilament light protein (NfL) concentration from baseline to Week 24.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Disease Progression Biomarker
|
0.086 ln(ng/L)
Standard Error 0.0247 • Interval 1.038 to 1.144
|
0.067 ln(ng/L)
Standard Error 0.0355 • Interval 0.997 to 1.146
|
-0.002 ln(ng/L)
Standard Error 0.0282 • Interval 0.944 to 1.055
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
Change from baseline to Week 24 in the activities of daily living (ADL)/independence domain score as assessed by the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40). The ALSAQ-40, a patient-self reported outcome, consists of 40 questions that are used to measure the subjective well-being of participants, and each question is scored from 0 (never) to 5 (always or cannot do at all). The ADL/independence domain score is based on 10 out of the 40 questions, with a maximum ADL/independence domain score of 50 and minimum score of 0. Higher domain scores indicate a worse subjective well-being or less independence completing ADLs.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=78 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Activities of Daily Living
|
13.643 Points
Standard Error 1.2961
|
12.049 Points
Standard Error 1.8617
|
13.701 Points
Standard Error 1.5115
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.
The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row.
Outcome measures
| Measure |
ABBV-CLS-7262 Dose 1
n=155 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=79 Participants
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=126 Participants
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Number of Participants That Experienced Death or Death Equivalent
|
8 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
ABBV-CLS-7262 Dose 1
Serious events: 21 serious events
Other events: 125 other events
Deaths: 6 deaths
ABBV-CLS-7262 Dose 2
Serious events: 7 serious events
Other events: 59 other events
Deaths: 3 deaths
Matching Placebo
Serious events: 6 serious events
Other events: 62 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ABBV-CLS-7262 Dose 1
n=155 participants at risk
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=79 participants at risk
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=76 participants at risk
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Faecaloma
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Haematemesis
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
General disorders
Complication associated with device
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
COVID-19
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Pneumonia
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
2.5%
2/79 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Sepsis
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Concussion
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.65%
1/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Investigations
Transaminases increased
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Muscle spasticity
|
0.65%
1/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Muscular weakness
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Product Issues
Device malfunction
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
3/155 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
2.5%
2/79 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Cardio-respiratory arrest
|
0.00%
0/155 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.65%
1/155 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/79 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
Other adverse events
| Measure |
ABBV-CLS-7262 Dose 1
n=155 participants at risk
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
ABBV-CLS-7262 Dose 2
n=79 participants at risk
ABBV-CLS-7262 is administered orally once per day for 24 weeks.
|
Matching Placebo
n=76 participants at risk
Matching placebo is administered orally once per day for 24 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
7.7%
12/155 • Number of events 13 • Up to 35 weeks after participant signed Master Protocol consent
|
10.1%
8/79 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
10.5%
8/76 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
2.5%
2/79 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
5/155 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
6.6%
5/76 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
5/155 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
2.6%
2/76 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Cognitive disorder
|
3.9%
6/155 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Dizziness
|
7.1%
11/155 • Number of events 14 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/79 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
13.2%
10/76 • Number of events 13 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Dysarthria
|
3.9%
6/155 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
6.6%
5/76 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Headache
|
13.5%
21/155 • Number of events 23 • Up to 35 weeks after participant signed Master Protocol consent
|
11.4%
9/79 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
15.8%
12/76 • Number of events 15 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Muscle contractions involuntary
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
3.8%
3/79 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Muscular weakness
|
12.3%
19/155 • Number of events 32 • Up to 35 weeks after participant signed Master Protocol consent
|
16.5%
13/79 • Number of events 21 • Up to 35 weeks after participant signed Master Protocol consent
|
18.4%
14/76 • Number of events 28 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Nervous system disorders
Neuromyopathy
|
7.1%
11/155 • Number of events 16 • Up to 35 weeks after participant signed Master Protocol consent
|
16.5%
13/79 • Number of events 20 • Up to 35 weeks after participant signed Master Protocol consent
|
10.5%
8/76 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Psychiatric disorders
Anxiety
|
1.9%
3/155 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Psychiatric disorders
Depression
|
1.3%
2/155 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
7/155 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
6.6%
5/76 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
5/155 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
8.9%
7/79 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
10.5%
8/76 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
1.9%
3/155 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
2.5%
2/79 • Number of events 2 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
9/155 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
2.5%
2/79 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
1.3%
1/76 • Number of events 1 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Urinary tract infection
|
3.9%
6/155 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
4/155 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
8.9%
7/79 • Number of events 12 • Up to 35 weeks after participant signed Master Protocol consent
|
3.9%
3/76 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Injury, poisoning and procedural complications
Fall
|
30.3%
47/155 • Number of events 83 • Up to 35 weeks after participant signed Master Protocol consent
|
35.4%
28/79 • Number of events 72 • Up to 35 weeks after participant signed Master Protocol consent
|
40.8%
31/76 • Number of events 69 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
9/155 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
6.3%
5/79 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
3.9%
3/76 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
3/155 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
5.1%
4/79 • Number of events 5 • Up to 35 weeks after participant signed Master Protocol consent
|
0.00%
0/76 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Constipation
|
14.8%
23/155 • Number of events 24 • Up to 35 weeks after participant signed Master Protocol consent
|
12.7%
10/79 • Number of events 12 • Up to 35 weeks after participant signed Master Protocol consent
|
15.8%
12/76 • Number of events 12 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Diarrhoea
|
11.0%
17/155 • Number of events 18 • Up to 35 weeks after participant signed Master Protocol consent
|
11.4%
9/79 • Number of events 10 • Up to 35 weeks after participant signed Master Protocol consent
|
10.5%
8/76 • Number of events 11 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
5/155 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
6.3%
5/79 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
7.9%
6/76 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Nausea
|
6.5%
10/155 • Number of events 11 • Up to 35 weeks after participant signed Master Protocol consent
|
3.8%
3/79 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
7.1%
11/155 • Number of events 11 • Up to 35 weeks after participant signed Master Protocol consent
|
8.9%
7/79 • Number of events 7 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
General disorders
Fatigue
|
5.8%
9/155 • Number of events 10 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
9.2%
7/76 • Number of events 8 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
COVID-19
|
8.4%
13/155 • Number of events 13 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
5.3%
4/76 • Number of events 4 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
8/155 • Number of events 9 • Up to 35 weeks after participant signed Master Protocol consent
|
7.6%
6/79 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
7.9%
6/76 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
6/155 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
3.8%
3/79 • Number of events 3 • Up to 35 weeks after participant signed Master Protocol consent
|
7.9%
6/76 • Number of events 6 • Up to 35 weeks after participant signed Master Protocol consent
|
Additional Information
Healey Center for ALS Project Management
Healey Center for ALS at Massachusetts General Hospital
Phone: 833-425-8257 (HALT ALS)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place