All > Complex Regional Pain Syndrome

LDN for Complex Regional Pain Syndrome

Stanford University, Palo Alto, CA
Complex Regional Pain SyndromeLDN - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether low-dose naltrexone can help relieve symptoms of complex regional pain syndrome. Participants will be given either LDN or a placebo for a few weeks, and will be asked to come in for several visits, which will include tests, physical assessments, and questionnaires.

Eligible Conditions
  • Complex Regional Pain Syndrome (CRPS)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Approximately 4 weeks after conclusion of treatment.

Week 4
Changes in pain severity

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
HA35 Treatment Group
1
Calaspargase Pegol-mknl
1
Temozolomide

Side Effects for

Naltrexone
67%Fatigue
59%Hyperglycemia
54%Platelet count decreased
37%Constipation
33%Anemia
33%White blood cell decreased
31%Lymphocyte count decreased
30%Alanine aminotransferase increased
30%Aspartate aminotransferase increased
30%Hypocalcemia
28%Nausea
28%Hypokalemia
19%Hyponatremia
17%Neutrophil count decreased
17%Hypoalbuminemia
15%Headache
15%Anorexia
13%Insomnia
11%Postnasal drip
11%Vomiting
11%Blood bilirubin increased
11%Seizure
9%Hoarseness
9%Thromboembolic event
9%Edema limbs
9%Creatinine increased
9%Dyspnea
9%Weight loss
9%Hypernatremia
7%Tremor
7%Psychiatric disorders - Other, specify
7%Upper respiratory infection
7%Anxiety
7%Rash maculo-papular
7%Pruritus
6%Dehydration
6%Fever
6%Hypoglycemia
6%Proteinuria
6%Mucositis oral
6%Hyperkalemia
6%Dysgeusia
6%Memory impairment
6%Hypertension
4%Fall
4%Depression
4%Dry skin
4%Confusion
4%Gastroesophageal reflux disease
4%Blurred vision
4%Urinary tract infection
4%Alkaline phosphatase increased
4%Muscle weakness right-sided
4%Acute kidney injury
4%Paresthesia
4%Epistaxis
4%Diarrhea
4%Generalized muscle weakness
4%Muscle weakness left-sided
4%Arthralgia
2%Edema face
2%Allergic rhinitis
2%Dyspepsia
2%Cough
2%Radiation recall reaction (dermatologic)
2%Nervous system disorders - Other, specify: BASELINE L HEMIPARESIS
2%Urinary incontinence
2%Sore throat
2%Gastrointestinal disorders - Other, specify: GI BUG
2%Infections and infestations - Other, specify: LLE CELLULITIS
2%Weight gain
2%Renal calculi
2%Rash acneiform
2%Pneumonitis
2%Conduction disorder
2%Gastrointestinal disorders - Other, specify: CHIPPED TOOTH
2%Pulmonary edema
2%Edema cerebral
2%Hemorrhoids
2%Papulopustular rash
2%Flu like symptoms
2%Infections and infestations - Other, specify: H-PYLORI
2%Cholecystitis
2%Infections and infestations - Other, specify: LYME'S DX
2%Non-cardiac chest pain
2%Nervous system disorders - Other, specify: DECREASED GRIP STRENGTH IN R HAND
2%Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN FEET
2%Chest wall pain
2%Agitation
2%Myositis
2%Neck pain
2%Nervous system disorders - Other, specify: L HEMIPARESIS
2%Nasal congestion
2%Alopecia
2%Skin and subcutaneous tissue disorders-MACULAR ERRYTHEMATOUS, BACK AND ABDOMEN
2%Chest pain - cardiac
2%Abdominal pain
2%Chills
2%Infections and infestations - Other, specify: SHINGLES
2%Muscle weakness lower limb
2%Cerebrospinal fluid leakage
2%Pain in extremity
2%Dysphasia
2%Cognitive disturbance
2%Ataxia
2%Nervous system disorders - Other, specify: LE WEAKNESS
2%Back pain
2%Peripheral sensory neuropathy
2%Myalgia
2%Hypersomnia
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT01303835) in the Naltrexone ARM group. Side effects include: Fatigue with 67%, Hyperglycemia with 59%, Platelet count decreased with 54%, Constipation with 37%, Anemia with 33%.

Trial Design

2 Treatment Groups

LDN
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: LDN · Has Placebo Group · N/A

LDN
Drug
Experimental Group · 1 Intervention: LDN · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LDN
2011
Completed Phase 2
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 4 weeks after conclusion of treatment.

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,222 Previous Clinical Trials
34,904,557 Total Patients Enrolled
Sean Mackey, MD, PhDPrincipal Investigator - Stanford University
Lucile Packard Children's Hospital Stanford, Stanford Hospital
University Of Arizona College Of Medicine (Medical School)
Tucson Hsps Medical Ed Prog Inc (Residency)
2 Previous Clinical Trials
563 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Complex Regional Pain Syndrome (CRPS) according to the Budapest criteria.
You have Complex Regional Pain Syndrome (CRPS) in your arms or legs.
You have had Complex Regional Pain Syndrome (CRPS) for one year or more.
References

Frequently Asked Questions

Do I meet the criteria to participate in this research endeavor?

"A maximum of 40 individuals between 18 and 65 years old who have been diagnosed with CRPS will be accepted into this trial. In addition, applicants must have upper or lower extremity CRPS, remain on a stable treatment regimen for at least 3 months prior to the study, have had their diagnosis for one year, and satisfy the Budapest criteria associated with complex regional pain syndromes." - Anonymous Online Contributor

Unverified Answer

Are applicants over 70 years old prohibited from participating in this trial?

"This trial requires individuals between 18 and 65 years old. Those younger than 18 can access 378 different clinical trials, while those older than 65 have access to 998 studies." - Anonymous Online Contributor

Unverified Answer

How many participants are being enlisted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the search for suitable patients is ongoing and has been since June 1st 2015. The most recent update was on August 15th 2022 and 40 individuals are required from a single site." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available for participants in this clinical trial?

"Indeed, clinicaltrials.gov reflects that this research is presently seeking participants. This experiment was initially advertised on June 1st 2015 and had its most recent update 15th August 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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