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NAC + Night Splints for Carpal Tunnel Syndrome (ACTS Trial)

Phase 4

Recruiting

Research Sponsored by Emily Krauss

Eligibility Criteria Checklist

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

Must have

The patient has a confirmed diagnosis of mild to moderate idiopathic unilateral or bilateral CTS as determined by both clinical exam findings and electrodiagnostic nerve conduction studies (median nerve distal motor latency ≥ 4.3 milliseconds and/or median nerve sensory distal latency ≥ 3.5 milliseconds at the wrist) performed within the preceding year prior to enrollment

The patient must be ≥ 18 years of age.

Must not have

Any current medications which preclude use of NAC including antibiotics or nitroglycerin

Any previous carpal tunnel release procedure on the ipsilateral limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial is testing whether taking a supplement called N-acetylcysteine (NAC) along with wearing a wrist splint at night can help people with mild to moderate carpal tunnel syndrome. The goal is to see if this combination reduces symptoms like pain and numbness better than just using a wrist splint alone. NAC is known for its anti-inflammatory effects, which might help improve nerve function and reduce the need for surgery.

Who is the study for?

This trial is for adults over 18 with mild to moderate Carpal Tunnel Syndrome (CTS) confirmed by clinical exam and nerve studies, who have had symptoms for at least 6 weeks. It's not for those who've tried splinting or steroid injections in the past 6 months, are on certain medications like antibiotics or nitroglycerin, have severe CTS, previous carpal surgery, pregnancy-related CTS, breastfeeding, kidney stones, financial barriers to getting a night splint or allergies to NAC.

What is being tested?

The ACTS Trial is testing if taking an oral medication called N-acetylcysteine (NAC), known for its safety and anti-inflammatory properties can improve symptoms of CTS when used with night-splinting. Participants will either receive NAC or a placebo alongside standard night splinting for 8 weeks. The study aims to see if this combination reduces the need for surgery.

What are the potential side effects?

N-acetylcysteine (NAC) is generally very safe with few side effects reported. However, some individuals might experience mild adverse reactions such as nausea, vomiting, rash or headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild to moderate carpal tunnel syndrome in the last year.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medications that interfere with NAC, like antibiotics or nitroglycerin.

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I have had carpal tunnel surgery on the same side as my current condition.

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I have severe carpal tunnel syndrome with constant hand pain or muscle weakness.

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I have had an injury to my neck or limb close to my body.

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I can't afford a night splint due to financial issues.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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%

Febrile illness

15%

Conjugated bilirubin 3 mg/dL >pre-KP value

Tachycardia

ALT 700 IU/L >pre-KP value

INR >2.0

Total bilirubin 5 mg/dL >pre-KP value

100%

80%

60%

40%

20%

Study treatment Arm

N-Acetylcysteine Treatment

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 7Eligibility criteria met