Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Stopped early · Not applicable
Conditions studied: Complex Regional Pain Syndrome I (CRPS I)
In brief
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.
Key facts
- Study ID
- NCT01623271
- Run by
- Massachusetts General Hospital
- People needed
- 5
- Starts
- 2013-05-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2020-07-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject will be between 18 to 80 years of age.
- Subject has not been on Gralise.
- Subject has not been on gabapentin for at least one month.
- 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.
- Subject has a VAS pain score of 5 or above at the beginning of the study.
- Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
- Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.
You may not qualify if…
- 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.)
- Subject has pending litigation related to his/her CRPS I condition.
- Subject is pregnant or lactating.
- Subject is allergic to gabapentin or Gralise.
- Subject has a positive urine (illicit) drug test.
- Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
- Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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