A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1

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Mayo Clinic

Status and phase

Completed
Phase 3

Conditions

Complex Regional Pain Syndrome, Type 1

Treatments

Drug: Lenalidamide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00166452
422-05

Details and patient eligibility

About

The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Age > or = to 18 years
  • Signed consent form
  • A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
  • CRPS pain intensity score at least 4 on an 11-point PI-NRS
  • Measurable sural, median sensory, median motor and peroneal motor nerve conductions
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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