A Study of Oxidative Pathways in MS Fatigue
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|ClinicalTrials.gov Identifier: NCT02804594|
Recruitment Status : Completed
First Posted : June 17, 2016
Results First Posted : February 18, 2020
Last Update Posted : July 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Progressive Multiple Sclerosis Fatigue||Drug: N-acetyl cysteine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
Active Comparator: N-acetyl cysteine
1250 mg of N-acetyl cysteine three times daily
Drug: N-acetyl cysteine
1250 mg of N- acetyl cysteine taken three times daily
Other Name: NAC
Placebo Comparator: Placebo
placebo three times daily
placebo taken three times daily
- Number of Adverse Events Reported Since Baseline Visit That Are Related to N-acetyl Cysteine. [ Time Frame: 4 weeks ]Number of adverse events reported since baseline visit that are related to N-acetyl cysteine will be compared to the number of adverse events reported by participants in the placebo group.
- Change in Fatigue Score on Questionnaires From Baseline [ Time Frame: 4 weeks ]Change in fatigue score on questionnaires from baseline visit to week-4 is calculated for the Modified Fatigue Impact Scale (MFIS) questionnaire. The MFIS is a self-report measure to rate fatigue in Multiple Sclerosis. The total score, ranging from 0 to 84 is the sum of three subscales (physical, cognitive, and psychosocial functioning). Higher numbers indicate greater fatigue. Modified fatigue Impact scale of more than 38 is one of the inclusion criteria for the study. Study participants who scored higher value on the questionnaire at week-4 are considered to have worsened fatigue from the baseline visit.
- Change in Level of Blood Markers From Baseline [ Time Frame: 4 weeks ]Baseline to week 4 change in blood GSH/GSSG ratio (wherein GSH is glutathione in reduced state and GSSG is glutathione in oxidized state) and grey matter GSH concentration on 7T MR spectroscopy (MRS) between groups. We hypothesize that fatigue is associated with the GSH/GSSG ratio.
- Changes in Metabolite Levels in Deep Grey Matter, and Surrounding White Matter on the Magnetic Resonance Images (MRI) From Baseline. [ Time Frame: 4 weeks ]Conventional T2/ T1-weighted images will be obtained at baseline for all subjects enrolled in the treatment phase of the study. We will perform brain MRI on 7T machine, and the sequences will be collected at baseline, and week-4 visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804594
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Emmanuelle Waubant, MD, PhD||University of California, San Francisco|