Complex Regional Pain Syndrome I (CRPS I) | Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Complex Regional Pain Syndrome I (CRPS I) research study
What is the primary objective of this study?
The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with certain types of neuropathic pain without causing too many side effects.
Who is eligible to participate?
Inclusion Criteria: 1. Subject will be between 18 to 80 years of age. 2. Subject has not been on Gralise. 3. Subject has not been on gabapentin for at least one month. 4. Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment. 5. Subject has a VAS pain score of 5 or above at the beginning of the study. 6. Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation. 7. Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit. Exclusion Criteria: 1. Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.) 2. Subject has pending litigation related to his/her CRPS I condition. 3. Subject is pregnant or lactating. 4. Subject is allergic to gabapentin or Gralise. 5. Subject has a positive urine (illicit) drug test. 6. Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history. 7. Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Complex Regional Pain Syndrome I (CRPS I)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CRPS I Pain SubjectsThis is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Start Date: May 2013
Completed Date: June 2014
Primary Outcome: Visual Analog Scale (VAS) at Visit 3
Study sponsors, principal investigator, and references
Principal Investigator: Jianren Mao, M.D., Ph.D.
Lead Sponsor: Massachusetts General Hospital
Mao J. Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. doi: 10.1016/j.jpain.2009.06.002. Epub 2009 Jul 22. Review.
Mao J, Chen LL. Systemic lidocaine for neuropathic pain relief. Pain. 2000 Jul;87(1):7-17. Review.
Mao J, Gold MS, Backonja MM. Combination drug therapy for chronic pain: a call for more clinical studies. J Pain. 2011 Feb;12(2):157-66. doi: 10.1016/j.jpain.2010.07.006. Epub 2010 Sep 17. Review.
Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. Review.
van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]. BMC Neurol. 2004 Sep 29;4:13.