Trial Outcomes & Findings for Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM) (NCT NCT02377921)
NCT ID: NCT02377921
Last Updated: 2019-06-27
Results Overview
Muscle strength based on the maximum voluntary isometric contraction (MVIC) against a dynamometer was measured bilaterally in the following upper extremity muscle groups: gross grip, shoulder abductors, elbow flexors, and elbow extensors. The UEC is derived from the sum of the average of the right and left total force values (measured in kg).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Ace-ER 6 g/Day
Aceneuramic acid extended-release (Ace-ER) 6 g/day, divided 3 times per day (TID) for 48 weeks.
|
Placebo
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ace-ER 6 g/Day
Aceneuramic acid extended-release (Ace-ER) 6 g/day, divided 3 times per day (TID) for 48 weeks.
|
Placebo
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Overall Study
Subject non-compliance
|
1
|
1
|
Baseline Characteristics
Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)
Baseline characteristics by cohort
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 7.91 • n=99 Participants
|
36.2 years
STANDARD_DEVIATION 8.59 • n=107 Participants
|
35.0 years
STANDARD_DEVIATION 8.29 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Upper Extremity Composite (UEC) Score
|
55.99 kg
STANDARD_DEVIATION 26.950 • n=99 Participants
|
56.31 kg
STANDARD_DEVIATION 29.287 • n=107 Participants
|
56.14 kg
STANDARD_DEVIATION 27.954 • n=206 Participants
|
|
Muscle Strength in the Knee Extensors
|
26.53 kg
STANDARD_DEVIATION 9.035 • n=99 Participants
|
26.65 kg
STANDARD_DEVIATION 8.969 • n=107 Participants
|
26.59 kg
STANDARD_DEVIATION 8.951 • n=206 Participants
|
|
Lower Extremity Composite (LEC) Score
|
53.52 kg
STANDARD_DEVIATION 33.751 • n=99 Participants
|
55.17 kg
STANDARD_DEVIATION 39.324 • n=107 Participants
|
54.33 kg
STANDARD_DEVIATION 36.378 • n=206 Participants
|
|
Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy Functional Activities Scale(GNEM-FAS) Mobility Score
|
26.38 units on a scale
STANDARD_DEVIATION 7.581 • n=99 Participants
|
26.23 units on a scale
STANDARD_DEVIATION 6.403 • n=107 Participants
|
26.31 units on a scale
STANDARD_DEVIATION 6.990 • n=206 Participants
|
|
Stands in Sit-to-Stand Test
|
12.38 stands
STANDARD_DEVIATION 4.103 • n=99 Participants
|
12.58 stands
STANDARD_DEVIATION 4.316 • n=107 Participants
|
12.48 stands
STANDARD_DEVIATION 4.185 • n=206 Participants
|
|
Lifts in Weighted Arm Lift Test
|
30.50 arm lifts
STANDARD_DEVIATION 10.452 • n=99 Participants
|
28.18 arm lifts
STANDARD_DEVIATION 9.824 • n=107 Participants
|
29.33 arm lifts
STANDARD_DEVIATION 10.137 • n=206 Participants
|
|
Distance Walked in 6-Minute Walk Test (6MWT)
|
367.0 meters
STANDARD_DEVIATION 115.07 • n=99 Participants
|
361.2 meters
STANDARD_DEVIATION 109.87 • n=107 Participants
|
364.2 meters
STANDARD_DEVIATION 111.95 • n=206 Participants
|
|
Percent of Predicted Distance Walked in 6MWT
|
49.97 percentage of predicted meters
STANDARD_DEVIATION 15.521 • n=99 Participants
|
49.87 percentage of predicted meters
STANDARD_DEVIATION 14.823 • n=107 Participants
|
49.92 percentage of predicted meters
STANDARD_DEVIATION 15.097 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Muscle strength based on the maximum voluntary isometric contraction (MVIC) against a dynamometer was measured bilaterally in the following upper extremity muscle groups: gross grip, shoulder abductors, elbow flexors, and elbow extensors. The UEC is derived from the sum of the average of the right and left total force values (measured in kg).
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in UEC Score (Total Force in kg) at Week 48
|
-2.25 kg
Interval -3.77 to -0.74
|
-2.99 kg
Interval -4.69 to -1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Lower extremity muscle strength in the knee extensors was measured by dynamometry. Bilateral total force was defined as the average of the right and left force values (measured in kg).
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in Muscle Strength in the Knee Extensors at Week 48
|
0.05 kg
Interval -1.19 to 1.29
|
0.45 kg
Interval -1.2 to 2.1
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Muscle strength based on MVIC against a dynamometer was measured bilaterally in the following lower extremity muscle groups: knee flexors, hip flexors, hip extensors, hip abductors and hip adductors. The LEC is derived from the sum of the average of the right and left total force values (measured in kg).
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in LEC Score (Total Force in kg) at Week 48
|
-1.92 kg
Interval -4.49 to 0.65
|
-0.44 kg
Interval -3.96 to 3.09
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Lower extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the lower extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in GNEM FAS Mobility Domain Score at Week 48
|
-2.49 units on a scale
Interval -3.56 to -1.42
|
-1.77 units on a scale
Interval -2.59 to -0.95
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Upper extremity function was assessed using a weighted arm lift test performed bilaterally. The number of times the participant can raise a 1 kg weight above the head in a 30-second period was recorded.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in Number of Lifts in the 30 Second Weighted Arm Lift Test at Week 48
|
0.03 arm lifts
Interval -2.19 to 2.26
|
2.79 arm lifts
Interval 0.21 to 5.38
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Lower extremity function was assessed using a sit-to-stand test. The number of times the participant can rise from a seated to a standing position in a 30-second period was recorded.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in Number of Stands in the Sit to Stand Test at Week 48
|
0.11 stands
Interval -0.55 to 0.77
|
0.53 stands
Interval -0.21 to 1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
The total distance walked (meters) in a 6-minute period was measured.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in Meters Walked in the 6MWT at Week 48
|
-17.79 meters
Interval -32.09 to -3.5
|
-6.81 meters
Interval -16.83 to 3.21
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in Percent Predicted Meters Walked in the 6MWT at Week 48
|
-2.37 percentage of predicted meters
Interval -4.3 to -0.44
|
-0.97 percentage of predicted meters
Interval -2.32 to 0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.
Upper extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the upper extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.
Outcome measures
| Measure |
Ace-ER 6 g/Day
n=45 Participants
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=43 Participants
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Change From Baseline in GNEM FAS Upper Extremity Domain Score at Week 48
|
-1.40 units on a scale
Interval -2.21 to -0.58
|
-1.08 units on a scale
Interval -1.86 to -0.29
|
Adverse Events
Ace-ER 6 g/Day
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ace-ER 6 g/Day
n=45 participants at risk
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=44 participants at risk
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.2%
1/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
0.00%
0/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
0.00%
0/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
2.3%
1/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
Other adverse events
| Measure |
Ace-ER 6 g/Day
n=45 participants at risk
Ace-ER 6 g/day, divided TID for 48 weeks.
|
Placebo
n=44 participants at risk
Matching placebo TID for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
10/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.8%
8/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
13.6%
6/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
6/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
11.4%
5/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
3/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
0.00%
0/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
5/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
4.5%
2/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
General disorders
Asthenia
|
4.4%
2/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
General disorders
Fatigue
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
General disorders
Influenza like illness
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
25.0%
11/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
General disorders
Pain
|
2.2%
1/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
5/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
2.3%
1/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
0.00%
0/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Injury, poisoning and procedural complications
Fall
|
15.6%
7/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
15.9%
7/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
4.5%
2/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
9/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
11.4%
5/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
5/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.3%
6/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
4.5%
2/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
6/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
2.3%
1/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
2.3%
1/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
3/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
0.00%
0/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Nervous system disorders
Headache
|
15.6%
7/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
15.9%
7/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
6.8%
3/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
5/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
9.1%
4/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
2.3%
1/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.9%
4/45 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
4.5%
2/44 • Screening through Week 48 plus 28 days (+5 days). The mean (SD) duration of treatment was 340.2 (12.02) days and 332.9 (40.86) days for the Ace-ER and placebo groups, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER