Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)|
- Visual Analog Scale (VAS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Functional status [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Using the SF-MPQ questionnaire we can determine the subject's health and well-being, especially relating to their daily activities.
- Side Effect Profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Common side effects include: dizziness, drowsiness, headaches, and swelling in extremities. Other side effects may include suicidal behavior or ideation and depression.
- Drop Out Rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Medication titration
Medication titration over the first 2 weeks to maximum of 1800mg/day.
Titrating standard dosage for 8 weeks.
Other Name: Gralise
This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623271
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jianren Mao, M.D., Ph.D.||Massachusetts General Hospital|