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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
There are no approved medications that are neuroprotective or able to slow disability accumulation in secondary progressive multiple sclerosis (SPMS). This two-year study will determine if daily oral intake of lipoic acid, a natural supplement, will prove superior to placebo in reducing injury to the brain and reducing disability progression in SPMS. Neuroprotection will be measured by the extent of brain volume loss seen on MRI, and disability will be measured by neurological status and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: lipoic acid | Experimental | 28 subjects receive oral lipoic acid 1200mg daily |
|
| Arm 2: placebo | Placebo Comparator | 28 subjects receive placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipoic acid | Drug | 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain Atrophy by MRI | % change brain volume from baseline to year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Measures: Mobility | Change in Timed 25 Foot Walk from baseline to year 2 | |
| Safety Measure: Adverse Events | adverse events recorded from baseline to year 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Spain, MD MSPH | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30477834 | Derived | Loy BD, Fling BW, Horak FB, Bourdette DN, Spain RI. Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis. Complement Ther Med. 2018 Dec;41:169-174. doi: 10.1016/j.ctim.2018.09.006. Epub 2018 Sep 22. | |
| 28680916 | Derived | Spain R, Powers K, Murchison C, Heriza E, Winges K, Yadav V, Cameron M, Kim E, Horak F, Simon J, Bourdette D. Lipoic acid in secondary progressive MS: A randomized controlled pilot trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e374. doi: 10.1212/NXI.0000000000000374. eCollection 2017 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brain Atrophy by MRI | 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. | Posted | Mean | Standard Deviation | whole brain percent volume change | % change brain volume from baseline to year 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Spain, MD, MSPH | Oregon Health & Science University | 503-494-5759 | spainr@ohsu.edu |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo | Drug | 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 |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Disability Measures: Mobility | 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. | Posted | Mean | Standard Deviation | seconds | Change in Timed 25 Foot Walk from baseline to year 2 |
|
|
|
| Secondary | Safety Measure: Adverse Events | Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group. | Posted | Number | occurences | adverse events recorded from baseline to year 2 |
|
|
|
| 9 |
| 28 |
| 25 |
| 28 |
| EG001 | 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 | 6 | 26 | 22 | 26 |
| Urinary Tract Infection | Infections and infestations |
|
| Appendicitis | Gastrointestinal disorders |
|
| Pneumonia | Infections and infestations |
|
| Renal Failure | Renal and urinary disorders |
|
| Proteinuria | Renal and urinary disorders |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Suicidal Ideation | Psychiatric disorders |
|
| Confusion | Psychiatric disorders |
|
| Fall | Injury, poisoning and procedural complications |
|
| Burn | Injury, poisoning and procedural complications |
|
| CPK elevation | Investigations |
|
| Neoplasm: Prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Deep Vein Thrombosis | Vascular disorders |
|
| Hypothyroidism | Endocrine disorders |
|
| Vertigo | Ear and labyrinth disorders |
|
| Spider Bite | Injury, poisoning and procedural complications |
|
| Ankle Sprain | Injury, poisoning and procedural complications |
|
| Optic Neuritis | Eye disorders |
|
| Peripapillary choroidal neovascularization | Eye disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Gastritis | Gastrointestinal disorders |
|
| Gatroparesis | Gastrointestinal disorders |
|
| GERD | Gastrointestinal disorders |
|
| Indigestion | Gastrointestinal disorders |
|
| GI upset | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Edema of lower limbs | General disorders |
|
| Fatigue | General disorders |
|
| Flu-like symptoms | General disorders |
|
| Gall bladder inflammation | Hepatobiliary disorders |
|
| Appendicitis | Infections and infestations |
|
| Eye Infection (stye) | Infections and infestations |
|
| Fungal skin infection | Infections and infestations |
|
| Lung Infection | Infections and infestations |
|
| Oral ulcers | Infections and infestations |
|
| Elevated Liver Enzymes | Investigations |
|
| Otis externa | Infections and infestations |
|
| Otis media | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Prostatitis | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Skin Infection | Infections and infestations |
|
| Vaginitis | Infections and infestations |
|
| Varicella Zoster | Infections and infestations |
|
| Viral Syndrome | Infections and infestations |
|
| Abrasion (due to fall) | Injury, poisoning and procedural complications |
|
| Left hand crush injury | Injury, poisoning and procedural complications |
|
| Left Knee Meniscus Tear | Injury, poisoning and procedural complications |
|
| Low WBC | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders |
|
| Tendonitis (Right Knee) | Musculoskeletal and connective tissue disorders |
|
| Dysegusia | Nervous system disorders |
|
| Face tingling/numbness | Nervous system disorders |
|
| MS Relapse | Nervous system disorders |
|
| Radiculitis | Nervous system disorders |
|
| Vasovagal reaction | Nervous system disorders |
|
| Kidney Stone with hydronephrosis | Renal and urinary disorders |
|
| nocturnal enuresis | Renal and urinary disorders |
|
| Proteinuria | Renal and urinary disorders |
|
| rash (maculo-papular) | Skin and subcutaneous tissue disorders |
|
| Hernia repair | Surgical and medical procedures |
|
| surgical procedure- baclofen pump | Surgical and medical procedures |
|
| Trigeminal neuralgia surgery | Surgical and medical procedures |
|
| Benign nevi removed | Surgical and medical procedures |
|
| Alkaline Phosphatase | Investigations |
|
| Elevated creatinine | Investigations |
|
| R. Eye Visual Sx | Eye disorders |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |