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Opiate Antagonist

Low Dose Naltrexone for Complex Regional Pain Syndrome (LDN-CRPS Trial)

Phase 4

Waitlist Available

Led By Semih Gungor, M.D.

Research Sponsored by Hospital for Special Surgery, New York

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 within 2 years of study start

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to study the effects of low dose naltrexone on patients with Complex Regional Pain Syndrome (CRPS). Patients will be randomly assigned to receive either low dose naltrexone or

Who is the study for?

This trial is for individuals with Complex Regional Pain Syndrome (CRPS), a rare chronic pain condition. Participants should be willing to take medication daily and attend three in-person follow-up visits over six months. Specific inclusion and exclusion criteria details are not provided.

What is being tested?

The study is testing the effectiveness of low dose naltrexone, an opiate blocker, compared to placebo sugar capsules in managing CRPS pain. Patients will be randomly assigned to either treatment without knowing which one they receive.

What are the potential side effects?

While specific side effects are not listed, naltrexone can typically cause nausea, headache, dizziness, fatigue or insomnia. Placebo capsules generally have no active ingredients but can sometimes result in perceived side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion (approximately 2 years after study initiation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion (approximately 2 years after study initiation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion (approximately 2 years after study initiation) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of study patients enrolled

Number of study patients randomized

Number of study patients who received the study medication

Secondary study objectives

Average NRS pain

Blinding assessment

CRPS symptom severity

+3 more

Other study objectives

Drop-out rate

Enrollment rate

Reasons for drop-out

+2 more

Side effects data

From 2018 Phase 1 & 2 trial • 11 Patients • NCT03278886

13%

Body injury during fight

13%

Dry mouth

13%

Loss of appetite

13%

Neck pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Naltrexone

Nalmefene

Awards & Highlights

Pivotal Trial

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

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: Low dose naltrexoneExperimental Treatment1 Intervention

Half of all enrolled patients will be randomized to receive capsules with the active low dose naltrexone (LDN) ingredient. LDN will be titrated over time to minimize potential side effects, with the initial dose starting at 1.5mg and eventually increasing up to 4.5mg. Neither the patient nor treating physician will be aware of the group in which the patient was randomized into until after study conclusion. All patients will be requested to take the respective daily dose and follow the titration schedule as instructed. All patients enrolled in the study, regardless of their randomization, will have standard of care treatment for CRPS according to their symptoms and the clinical judgment of the treating clinician.

Group II: Placebo sugar capsulesPlacebo Group1 Intervention

Half of all enrolled patients will be randomized to receive placebo sugar capsules. Neither the patient nor treating physician will be aware of the group in which the patient was randomized into until after study conclusion. All patients will be requested to take the respective daily dose and follow the titration schedule as instructed. All patients enrolled in the study, regardless of their randomization, will have standard of care treatment for CRPS according to their symptoms and the clinical judgment of the treating clinician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low dose naltrexone

2018

Completed Phase 4

~70

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