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N-Acetyl cysteine for Carpal Tunnel Syndrome (ACTS Trial)

Phase 4

Waitlist Available

Research Sponsored by David Tang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

ACTS Trial Summary

This trial will study whether the supplement N-acetylcysteine could help treat carpal tunnel syndrome when taken alongside a standard 8-week trial of night splinting.

Eligible Conditions

Carpal Tunnel Syndrome
Splints
Carpal Tunnel Release
Hand Injuries and Disorders
Nerve Compression

ACTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 8 weeks

Secondary outcome measures

Change from baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 months

Number of participants who elect to have surgical carpal tunnel decompression after 6 months

Number of participants who elect to have surgical carpal tunnel decompression after 8 weeks

Side effects data

From 2024 Phase 2 trial • 13 Patients • NCT03499249

62%

GGT 400 IU/L >pre-KP value

46%

AST 400 IU/L >pre-KP value

31%

Loss of an IV

23%

Emesis with feeds

15%

Conjugated bilirubin 3 mg/dL >pre-KP value

15%

Febrile illness

INR >2.0

Total bilirubin 5 mg/dL >pre-KP value

Tachycardia

ALT 700 IU/L >pre-KP value

100%

80%

60%

40%

20%

Study treatment Arm

N-Acetylcysteine Treatment

ACTS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NAC GroupExperimental Treatment2 Interventions

Participants in this group will given an N-acetylcysteine 500mg oral tablet daily in addition to wearing a standard carpal tunnel splint nightly (worn approximately 6-8 hours/day). Both interventions will take place concurrently for a total of 8 consecutive weeks.

Group II: Placebo GroupPlacebo Group1 Intervention

Participants in this group will be given a placebo table to be taken orally daily in addition to wearing a standard carpal tunnel splint nightly (worn approximately 6-8 hours/day). Both interventions will take place concurrently for a total of 8 consecutive weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Wrist Splint

2022

Completed Phase 4

~290

Cysteine

FDA approved

Do I qualify?Apply below to find out

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Who is running the clinical trial?

David TangLead Sponsor

Michael Bezuhly, MDStudy DirectorNSHA

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants that can join this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that this study is actively recruiting, having been posted on August 1st 2021 and most recently updated three days later. This clinical trial requires 240 participants to be recruited from a single medical centre."

Answered by AI

Are there still opportunities for participants in this experiment?

"Data available on clinicaltrials.gov indicates that this medical study is actively recruiting participants and has been modified recently, with the most recent edit occurring on August 3rd 2021. The trial was first published 8/1/2021"

Answered by AI