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Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis (NACPMS)

Primary Purpose

Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine
Placebo
Sponsored by
Emmanuelle Waubant, MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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
  • 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)

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

N-acetyl cysteine

Placebo

Arm Description

N-acetyl cysteine (NAC) 1200mg t.i.d.

Placebo 1200mg t.i.d.

Outcomes

Primary Outcome Measures

Safety and tolerability
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
The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.

Secondary Outcome Measures

Clinical effects of NAC
Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).

Full Information

First Posted
November 8, 2021
Last Updated
March 30, 2023
Sponsor
Emmanuelle Waubant, MD PhD
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05122559
Brief Title
Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis
Acronym
NACPMS
Official Title
Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emmanuelle Waubant, MD PhD
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetyl cysteine
Arm Type
Active Comparator
Arm Description
N-acetyl cysteine (NAC) 1200mg t.i.d.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1200mg t.i.d.
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
N-acetyl cysteine (NAC) is a Glutathione (GSH) precursor with antioxidant properties which make it relevant for neuroprotection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lactose Monohydrate, USP (100%), magnesium stearate, silicon dioxide NF
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Number of adverse events recorded by system, severity, and by relationship to treatment arm.
Time Frame
15 months
Title
Effect of NAC on on progression of brain, thalamic and cervical cord atrophy
Description
The primary endpoint is brain, thalamic and cord atrophy measured by brain and cervical spine MRI at month 3 and month 15.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Clinical effects of NAC
Description
Clinical effects in MS as measured by the 9-HPT, 25-foot walk, symbol digit modalities test (SDMT).
Time Frame
15 months
Other Pre-specified Outcome Measures:
Title
Effect of NAC on progression of MS
Description
Monitoring progression using imaging metrics and changes captured by a wearable multi-sensor device.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: - 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uk Sok Shin, BA
Phone
(415) 321-9373
Email
uksok.shin@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle Waubant, MD, PhD
Phone
415-514-8199
Email
emmanuelle.waubant@ucsf.edu
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uk Sok Shin, B.A.
Phone
415-321-9373
Email
uksok.shin@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Alina Dobai, M.D.
Phone
415-476-4882
Email
AlinaLoredana.Dobai@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36182028
Citation
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.
Results Reference
derived

Learn more about this trial

Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis

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