Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis

Who is this study for? Patients with progressive multiple sclerosis
What treatments are being studied? N-acetyl cysteine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• \- 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Uk Sok Shin, BA
uksok.shin@ucsf.edu
(415) 321-9373
Backup
Emmanuelle Waubant, MD, PhD
emmanuelle.waubant@ucsf.edu
415-514-8199
Time Frame
Start Date: 2022-02-16
Estimated Completion Date: 2027-02
Participants
Target number of participants: 98
Treatments
Active_comparator: N-acetyl cysteine
N-acetyl cysteine (NAC) 1200mg t.i.d.
Placebo_comparator: Placebo
Placebo 1200mg t.i.d.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Emmanuelle Waubant, MD PhD

This content was sourced from clinicaltrials.gov