Trial Outcomes & Findings for Lipoic Acid for Progressive Multiple Sclerosis (MS) (NCT NCT03161028)
NCT ID: NCT03161028
Last Updated: 2025-03-03
Results Overview
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
24 months
Results posted on
2025-03-03
Participant Flow
Participants were recruited from 5 Veteran Affairs Medical Centers, 1 Medical Health System, and 5 US and Canada University Hospitals. The first participant was enrolled on August 17, 2018 and the last participant was enrolled in January 2022.
Participant milestones
| Measure |
Lipoic Acid
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
61
|
|
Overall Study
COMPLETED
|
34
|
51
|
|
Overall Study
NOT COMPLETED
|
20
|
10
|
Reasons for withdrawal
| Measure |
Lipoic Acid
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Study drug side effects
|
2
|
2
|
|
Overall Study
Administrative PD/UP
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Unable to comply with procedures
|
1
|
1
|
Baseline Characteristics
Lipoic Acid for Progressive Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
58.6 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
59.1 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 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
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
MS Subtype
Primary progressive MS (PPMS)
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
MS Subtype
Secondary progressive MS (SPMS)
|
38 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
EDSS
|
6.0 score
n=99 Participants
|
6.0 score
n=107 Participants
|
6.0 score
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants assigned to lipoic acid or placebo).
T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). The change in walking speed across 24 months was compared between treatment groups using a mixed models analysis.
Outcome measures
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Change in Mobility: Timed 25 Foot Walk
|
-0.39 feet per second
Interval -0.58 to -0.2
|
-0.30 feet per second
Interval -0.46 to -0.14
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants assigned to lipoic acid or placebo).
The score is the distance, in meters, the subject walks in 2 minutes. The change in walking distance across 24 months was compared between treatment groups using a mixed models analysis.
Outcome measures
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Change in Mobility: 2-minute Timed Walk
|
-7.25 meters
Interval -16.57 to 2.07
|
-8.02 meters
Interval -15.97 to -0.08
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants assigned to lipoic acid or placebo).
Change in number of falls recorded from Baseline to year 2
Outcome measures
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Mobility: Fall Count
|
0.65 Falls
Interval 0.3 to 1.39
|
0.63 Falls
Interval 0.33 to 1.18
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants assigned to lipoic acid or placebo).
Change in whole brain volume from baseline to 24 months
Outcome measures
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Brain Atrophy by MRI
|
-0.58 cm3
Interval -6.29 to 5.13
|
-7.18 cm3
Interval -11.95 to -2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Intent to Treat Population (all participants assigned to lipoic acid or placebo).
Participants with at least 1 treatment-emergent AE
Outcome measures
| Measure |
Lipoic Acid
n=54 Participants
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 Participants
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Safety: Adverse Event Monitoring
|
35 Participants
|
30 Participants
|
Adverse Events
Lipoic Acid
Serious events: 11 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lipoic Acid
n=54 participants at risk
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 participants at risk
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
1.9%
1/54 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
3.7%
2/54 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.7%
2/54 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic hypercarbic respiratory failure
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 3 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Infections and infestations
Sepsis
|
3.7%
2/54 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
3.3%
2/61 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage IV
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Vascular disorders
Cardiogenic shock
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain (non-cardiac)
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Hepatobiliary disorders
Cholecystitis NOS
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Surgical and medical procedures
Cholecystectomy
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Nervous system disorders
Muscular weakness
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoid cystic carcinoma
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Musculoskeletal and connective tissue disorders
Pelvic fracture
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Vascular disorders
Traumatic haemothorax
|
1.9%
1/54 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
0.00%
0/61 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia NOS
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
3.3%
2/61 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Vascular disorders
Syncope
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
1.6%
1/61 • Number of events 1 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
Other adverse events
| Measure |
Lipoic Acid
n=54 participants at risk
Participants received 1200mg daily lipoic acid orally for 24 months. Lipoic acid: 1200 mg capsule
|
Placebo
n=61 participants at risk
Participants received placebo capsule matching lipoic acid orally for 24 months.
Placebo: lipoic acid placebo capsule
|
|---|---|---|
|
Investigations
Glomerular filtration rate decreased
|
24.1%
13/54 • Number of events 15 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
14.8%
9/61 • Number of events 12 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Renal and urinary disorders
Proteinuria
|
20.4%
11/54 • Number of events 14 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
3.3%
2/61 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
6/54 • Number of events 6 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
13.1%
8/61 • Number of events 9 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
3/54 • Number of events 3 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
4.9%
3/61 • Number of events 4 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/54 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
14.8%
9/61 • Number of events 14 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
6/54 • Number of events 6 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
3.3%
2/61 • Number of events 2 • 2 years of treatment
AE and laboratory abnormalities were captured and categorized using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The Suicide Behaviors Questionnaire-Revised (SBQ-R) was used to monitor for suicidality as required by the Food \& Drug Administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place