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Opiate Antagonist
Low dose naltrexone for Complex Regional Pain Syndrome (LDN-CRPS Trial)
Phase 4
Waitlist Available
Led By Alexandra Sideris, PhD
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
LDN-CRPS Trial 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.Check my eligibility
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.See study design
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.
LDN-CRPS Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of study patients enrolled
Number of study patients randomized
Number of study patients who received the study medication
Secondary outcome measures
Average NRS pain
Blinding assessment
CRPS symptom severity
+3 moreOther outcome measures
Drop-out rate
Enrollment rate
Reasons for drop-out
+2 moreSide effects data
From 2018 Phase 1 & 2 trial • 11 Patients • NCT0327888667%
Anxiety
67%
Dizziness
67%
Nausea
67%
Weakness
33%
Irritability
33%
Confusion
33%
Abnormal dreams/nightmares
33%
Tremor
33%
Sleep problems
33%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nalmefene
Low Dose Naltrexone
LDN-CRPS 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
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,324 Total Patients Enrolled
Alexandra Sideris, PhDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
36 Total Patients Enrolled
Semih Gungor, M.D.Principal InvestigatorHospital for Special Surgery, New York
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals who are above the age of 30 eligible to participate in this research study?
"To be eligible for participation in this study, individuals must fall between the ages of 18 and 65 years old."
Answered by AI
What are the specific criteria for eligible participants to be enrolled in this medical study?
"Candidates eligible for enrollment in this study must possess a diagnosis of complex regional pain syndrome and fall within the age bracket of 18 to 65. The trial aims to recruit approximately 40 participants."
Answered by AI
Has the FDA authorized the use of low-dose naltrexone?
"With the trial now in Phase 4, indicating it has received official approval, our experts at Power have rated the safety of low-dose naltrexone as a solid 3 on our scale."
Answered by AI
Are new participants still being accepted for enrollment in this research study?
"According to clinicaltrials.gov, this specific trial is no longer seeking participants. Its initial posting was on April 1st, 2024, with the last update made on March 5th, 2024. It's worth noting that while this study is closed for recruitment, there are currently 1872 other trials actively enrolling participants."
Answered by AI
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