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Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01188811
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Chronic Progressive
Interventions Drug: lipoic acid
Drug: Placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lipoic Acid Placebo
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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.

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

Period Title: Overall Study
Started 28 26
Completed 22 24
Not Completed 6 2
Reason Not Completed
Withdrawal by Subject             0             2
Adverse Event             6             0
Arm/Group Title Lipoic Acid Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 28 26 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
26
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 26 participants 54 participants
57.9  (6.7) 59.7  (6.1) 58.7  (6.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
Female
16
  57.1%
16
  61.5%
32
  59.3%
Male
12
  42.9%
10
  38.5%
22
  40.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 26 participants 54 participants
28 26 54
1.Primary Outcome
Title Brain Atrophy by MRI
Hide Description [Not Specified]
Time Frame % change brain volume from baseline to year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lipoic Acid Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 20 24
Mean (Standard Deviation)
Unit of Measure: whole brain percent volume change
-0.4  (0.7) -1.3  (1.1)
2.Secondary Outcome
Title Disability Measures: Mobility
Hide Description [Not Specified]
Time Frame Change in Timed 25 Foot Walk from baseline to year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lipoic Acid Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 21 17
Mean (Standard Deviation)
Unit of Measure: seconds
-1.0  (2.8) 0.1  (2.0)
3.Secondary Outcome
Title Safety Measure: Adverse Events
Hide Description [Not Specified]
Time Frame adverse events recorded from baseline to year 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.
Arm/Group Title Lipoic Acid Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: occurences
Total number adverse events 81 69
Total number serious adverse events 9 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lipoic Acid Placebo
Hide Arm/Group Description

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.

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

All-Cause Mortality
Lipoic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lipoic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/28 (32.14%)      6/26 (23.08%)    
Gastrointestinal disorders     
Emesis  1/28 (3.57%)  1 0/26 (0.00%)  0
Appendicitis  1/28 (3.57%)  1 0/26 (0.00%)  0
Infections and infestations     
Urinary Tract Infection  2/28 (7.14%)  2 1/26 (3.85%)  1
Pneumonia  0/28 (0.00%)  0 1/26 (3.85%)  1
Injury, poisoning and procedural complications     
Fall  0/28 (0.00%)  0 2/26 (7.69%)  2
Burn  0/28 (0.00%)  0 1/26 (3.85%)  1
Investigations     
CPK elevation  0/28 (0.00%)  0 1/26 (3.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer  1/28 (3.57%)  1 0/26 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation  1/28 (3.57%)  1 0/26 (0.00%)  0
Confusion  1/28 (3.57%)  1 0/26 (0.00%)  0
Renal and urinary disorders     
Renal Failure  1/28 (3.57%)  1 0/26 (0.00%)  0
Proteinuria  1/28 (3.57%)  1 0/26 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lipoic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/28 (89.29%)      22/26 (84.62%)    
Ear and labyrinth disorders     
Vertigo  0/28 (0.00%)  0 1/26 (3.85%)  1
Endocrine disorders     
Hypothyroidism  0/28 (0.00%)  0 1/26 (3.85%)  1
Eye disorders     
Optic Neuritis  1/28 (3.57%)  1 0/26 (0.00%)  0
Peripapillary choroidal neovascularization  0/28 (0.00%)  0 1/26 (3.85%)  1
R. Eye Visual Sx  1/28 (3.57%)  1 0/26 (0.00%)  0
Gastrointestinal disorders     
Constipation  1/28 (3.57%)  1 0/26 (0.00%)  0
Diarrhea  1/28 (3.57%)  1 2/26 (7.69%)  2
Dyspepsia  0/28 (0.00%)  0 1/26 (3.85%)  1
Gastritis  2/28 (7.14%)  3 0/26 (0.00%)  0
Gatroparesis  1/28 (3.57%)  1 0/26 (0.00%)  0
GERD  0/28 (0.00%)  0 1/26 (3.85%)  1
Indigestion  1/28 (3.57%)  1 0/26 (0.00%)  0
GI upset  2/28 (7.14%)  2 0/26 (0.00%)  0
Nausea  4/28 (14.29%)  4 0/26 (0.00%)  0
Vomiting  2/28 (7.14%)  3 0/26 (0.00%)  0
General disorders     
Edema of lower limbs  1/28 (3.57%)  1 0/26 (0.00%)  0
Fatigue  0/28 (0.00%)  0 1/26 (3.85%)  1
Flu-like symptoms  3/28 (10.71%)  5 2/26 (7.69%)  2
Hepatobiliary disorders     
Gall bladder inflammation  1/28 (3.57%)  1 0/26 (0.00%)  0
Infections and infestations     
Appendicitis  1/28 (3.57%)  1 0/26 (0.00%)  0
Eye Infection (stye)  0/28 (0.00%)  0 1/26 (3.85%)  1
Fungal skin infection  1/28 (3.57%)  1 0/26 (0.00%)  0
Lung Infection  1/28 (3.57%)  1 1/26 (3.85%)  1
Oral ulcers  0/28 (0.00%)  0 1/26 (3.85%)  1
Otis externa  1/28 (3.57%)  1 0/26 (0.00%)  0
Otis media  1/28 (3.57%)  1 1/26 (3.85%)  1
Urinary Tract Infection  6/28 (21.43%)  8 8/26 (30.77%)  11
Prostatitis  0/28 (0.00%)  0 1/26 (3.85%)  1
Sinusitis  1/28 (3.57%)  1 1/26 (3.85%)  1
Skin Infection  1/28 (3.57%)  1 1/26 (3.85%)  1
Vaginitis  0/28 (0.00%)  0 1/26 (3.85%)  1
Varicella Zoster  1/28 (3.57%)  1 0/26 (0.00%)  0
Viral Syndrome  1/28 (3.57%)  1 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  9/28 (32.14%)  11 13/26 (50.00%)  23
Spider Bite  1/28 (3.57%)  1 0/26 (0.00%)  0
Ankle Sprain  1/28 (3.57%)  1 0/26 (0.00%)  0
Abrasion (due to fall)  1/28 (3.57%)  1 0/26 (0.00%)  0
Left hand crush injury  1/28 (3.57%)  1 0/26 (0.00%)  0
Left Knee Meniscus Tear  0/28 (0.00%)  0 1/26 (3.85%)  1
Investigations     
Elevated Liver Enzymes  1/28 (3.57%)  1 1/26 (3.85%)  1
Low WBC  1/28 (3.57%)  1 1/26 (3.85%)  1
Alkaline Phosphatase  1/28 (3.57%)  1 0/26 (0.00%)  0
Elevated creatinine  1/28 (3.57%)  1 0/26 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  0/28 (0.00%)  0 1/26 (3.85%)  2
Dehydration  0/28 (0.00%)  0 1/26 (3.85%)  1
Hyperglycemia  1/28 (3.57%)  1 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoporosis  1/28 (3.57%)  1 0/26 (0.00%)  0
Tendonitis (Right Knee)  1/28 (3.57%)  1 0/26 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm: Prostate  1/28 (3.57%)  1 0/26 (0.00%)  0
Nervous system disorders     
Dysegusia  1/28 (3.57%)  1 0/26 (0.00%)  0
Face tingling/numbness  0/28 (0.00%)  0 1/26 (3.85%)  1
MS Relapse  0/28 (0.00%)  0 1/26 (3.85%)  1
Radiculitis  1/28 (3.57%)  1 0/26 (0.00%)  0
Vasovagal reaction  0/28 (0.00%)  0 1/26 (3.85%)  1
Renal and urinary disorders     
Kidney Stone with hydronephrosis  1/28 (3.57%)  1 0/26 (0.00%)  0
nocturnal enuresis  1/28 (3.57%)  1 0/26 (0.00%)  0
Proteinuria  1/28 (3.57%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash (maculo-papular)  2/28 (7.14%)  2 0/26 (0.00%)  0
Surgical and medical procedures     
Hernia repair  1/28 (3.57%)  1 0/26 (0.00%)  0
surgical procedure- baclofen pump  1/28 (3.57%)  1 0/26 (0.00%)  0
Trigeminal neuralgia surgery  1/28 (3.57%)  1 0/26 (0.00%)  0
Benign nevi removed  1/28 (3.57%)  1 0/26 (0.00%)  0
Vascular disorders     
Deep Vein Thrombosis  0/28 (0.00%)  0 1/26 (3.85%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rebecca Spain, MD, MSPH
Organization: Oregon Health & Science University
Phone: 503-494-5759
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01188811     History of Changes
Other Study ID Numbers: B7493-W
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: June 24, 2016
Results First Posted: February 2, 2017
Last Update Posted: February 2, 2017