Multiple SclerosisPhase 2NACPMSNCT05122559
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
A Phase 2 study testing N-acetyl cysteine in people with Multiple Sclerosis and Multiple Sclerosis, Primary Progressive, run by Emmanuelle Waubant, MD PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- What is being tested?
- N-acetyl cysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 40-70 (inclusive) years in age,
- meet 2017 McDonald criteria (Thompson 2018),
- patients with primary or secondary progressive MS (Thompson 2018),
- at least 2 years since progressive symptom onset,
- evidence of clinical changes over the previous 2 years unrelated to relapses: increased EDSS or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. Progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available.
- EDSS score 3.0 to 7.0 (inclusive),
- can be on a stable disease-modifying treatment initiated > 3 months prior to screening,
- can be on stable doses of dalfampridine initiated at least one month before screening.
Who cannot join
- - MS relapses in the previous 6 months
- oral glucocorticosteroid treatment within the prior 3 months
- patient with issues undergoing MRI scans
- pregnancy or breastfeeding
- women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study
- history of bleeding disorders
Show all 13Show fewer
- active gastrointestinal ulcers
- abnormal liver function testing (aminotransferase (AST) or alanine aminotransferase (ALT) >2 times upper limit of normal)
- current treatment for active malignancy or metastatic malignancy treated in the past year
- alcohol or substance use disorder
- allergy to NAC
- planned surgery or move within 15 months
- use of medications/supplements with antioxidant properties (including over-the-counter NAC)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- Being tested
- N-acetyl cysteine, Placebo
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
PlaceboDrug
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF
| Study group | Role | What they receive |
|---|---|---|
| N-acetyl cysteine | Active comparator | N-acetyl cysteine (NAC) 1200mg t.i.d. Receives: Drug: N-acetyl cysteine |
| Placebo | Placebo comparator | Placebo 1200mg t.i.d. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Number of adverse events recorded by system, severity, and by relationship to treatment arm.
Measured: 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.
Measured: 15 months
Secondary outcomes (1)
Clinical effects of NAC
Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start16 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emmanuelle Waubant, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Emmanuelle Waubant, MD PhD, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122559
- Sponsor's protocol ID
- P0549747
- Acronym
- NACPMS
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36182028
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05122559
- Acronym / sponsor ID
- NACPMS / P0549747
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Emmanuelle Waubant, MD PhDUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetyl cysteine | Active comparator | Drug: N-acetyl cysteineN-acetyl cysteine (NAC) 1200mg t.i.d. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1200mg t.i.d. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - 40-70 (inclusive) years in age,
- meet 2017 McDonald criteria (Thompson 2018),
- patients with primary or secondary progressive MS (Thompson 2018),
- at least 2 years since progressive symptom onset,
- evidence of clinical changes over the previous 2 years unrelated to relapses: increased EDSS or 20% slowing on 25-foot walk, change of ambulatory support, cognitive change documented on cognitive testing. Progression defined by patients in terms of ambulation perimeter or type of support to ambulate are acceptable if aforementioned physician-based measure changes are not available.
Key exclusion criteria (13 listed)
- - MS relapses in the previous 6 months
- oral glucocorticosteroid treatment within the prior 3 months
- patient with issues undergoing MRI scans
- pregnancy or breastfeeding
- women of child-bearing potential not able to utilize an effective form of contraception for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineAlso: NACN-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection. | Drug | N-acetyl cysteine |
| PlaceboLactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 15 months
Number of adverse events recorded by system, severity, and by relationship to treatment arm.
Effect of NAC on on progression of brain, thalamic and cervical cord atrophy
Time frame: 15 months
The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.
1 secondary outcome
Clinical effects of NAC
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 36182028Schoeps 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetyl cysteine in people with Multiple Sclerosis and Multiple Sclerosis, Primary Progressive, run by Emmanuelle Waubant, MD PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.