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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study evaluates the effectiveness of N-acetyl cysteine (NAC) in the treatment of progressive multiple sclerosis. Half of the patients will receive NAC, while the other half will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetyl cysteine | Active Comparator | N-acetyl cysteine (NAC) 1200mg t.i.d. |
|
| Placebo | Placebo Comparator | Placebo 1200mg t.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of adverse events recorded by system, severity, and by relationship to treatment arm. | 15 months |
| Effect of NAC on on progression of brain, thalamic and cervical cord atrophy | The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effects of NAC | Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT). | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of NAC on progression of MS | Monitoring progression using imaging metrics and changes captured by a wearable multi-sensor device. | 15 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36182028 | Derived | Schoeps VA, Graves JS, Stern WA, Zhang L, Nourbakhsh B, Mowry EM, Henry RG, Waubant E. N-Acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis (NACPMS) trial: Study protocol for a randomized, double-blind, placebo-controlled add-on phase 2 trial. Contemp Clin Trials. 2022 Nov;122:106941. doi: 10.1016/j.cct.2022.106941. Epub 2022 Sep 28. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| 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 |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |