Trial Outcomes & Findings for Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS) (NCT NCT01188811)
NCT ID: NCT01188811
Last Updated: 2017-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
54 participants
Primary outcome timeframe
% change brain volume from baseline to year 2
Results posted on
2017-02-02
Participant Flow
Participant milestones
| Measure |
Lipoic Acid
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Lipoic Acid
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Adverse Event
|
6
|
0
|
Baseline Characteristics
Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Lipoic Acid
n=28 Participants
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=26 Participants
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: % change brain volume from baseline to year 2Population: 22 subjects in the lipoic acid group and 24 in the placebo group completed the MRI outcome. Two outliers in the lipoic acid group were not included in analysis.
Outcome measures
| Measure |
Lipoic Acid
n=20 Participants
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=24 Participants
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Brain Atrophy by MRI
|
-0.4 whole brain percent volume change
Standard Deviation 0.7
|
-1.3 whole brain percent volume change
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Change in Timed 25 Foot Walk from baseline to year 2Population: Outliers were removed and intention-to-treat analysis was performed on data from 21 participants in the lipoic acid group and 17 in the placebo group.
Outcome measures
| Measure |
Lipoic Acid
n=21 Participants
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=17 Participants
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Disability Measures: Mobility
|
-1.0 seconds
Standard Deviation 2.8
|
0.1 seconds
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: adverse events recorded from baseline to year 2Population: Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.
Outcome measures
| Measure |
Lipoic Acid
n=27 Participants
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=24 Participants
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Safety Measure: Adverse Events
Total number serious adverse events
|
9 occurences
|
6 occurences
|
|
Safety Measure: Adverse Events
Total number adverse events
|
81 occurences
|
69 occurences
|
Adverse Events
Lipoic Acid
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lipoic Acid
n=28 participants at risk
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=26 participants at risk
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Gastrointestinal disorders
Emesis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
2/28 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Appendicitis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Psychiatric disorders
Suicidal Ideation
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28
|
7.7%
2/26 • Number of events 2
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Investigations
CPK elevation
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Lipoic Acid
n=28 participants at risk
28 subjects receive oral lipoic acid 1200mg daily
lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
|
Placebo
n=26 participants at risk
28 subjects receive placebo daily
Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
32.1%
9/28 • Number of events 11
|
50.0%
13/26 • Number of events 23
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm: Prostate
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spider Bite
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Ankle Sprain
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Eye disorders
Optic Neuritis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Eye disorders
Peripapillary choroidal neovascularization
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
2/28 • Number of events 3
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gatroparesis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Indigestion
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
GI upset
|
7.1%
2/28 • Number of events 2
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
14.3%
4/28 • Number of events 4
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Number of events 3
|
0.00%
0/26
|
|
General disorders
Edema of lower limbs
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Fatigue
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Flu-like symptoms
|
10.7%
3/28 • Number of events 5
|
7.7%
2/26 • Number of events 2
|
|
Hepatobiliary disorders
Gall bladder inflammation
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Appendicitis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Eye Infection (stye)
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Lung Infection
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Oral ulcers
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Investigations
Elevated Liver Enzymes
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Otis externa
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Otis media
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
21.4%
6/28 • Number of events 8
|
30.8%
8/26 • Number of events 11
|
|
Infections and infestations
Prostatitis
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Skin Infection
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Vaginitis
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Varicella Zoster
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Viral Syndrome
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Abrasion (due to fall)
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Left hand crush injury
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Left Knee Meniscus Tear
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Investigations
Low WBC
|
3.6%
1/28 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/28
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Tendonitis (Right Knee)
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
Dysegusia
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
Face tingling/numbness
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
MS Relapse
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Radiculitis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/28
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Kidney Stone with hydronephrosis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Renal and urinary disorders
nocturnal enuresis
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
rash (maculo-papular)
|
7.1%
2/28 • Number of events 2
|
0.00%
0/26
|
|
Surgical and medical procedures
Hernia repair
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Surgical and medical procedures
surgical procedure- baclofen pump
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Surgical and medical procedures
Trigeminal neuralgia surgery
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Surgical and medical procedures
Benign nevi removed
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Investigations
Alkaline Phosphatase
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Investigations
Elevated creatinine
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
|
Eye disorders
R. Eye Visual Sx
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
Additional Information
Rebecca Spain, MD, MSPH
Oregon Health & Science University
Phone: 503-494-5759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place