Clinical Trial: Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Visual Analog Scale (VAS) at Visit 3 [ Time Frame: At visit 3 ]

Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.


Original Primary Outcome: Visual Analog Scale (VAS) [ Time Frame: 1 year ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Functional status [ Time Frame: 1 year ]
    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 ]
    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 ]


Information By: Massachusetts General Hospital

Dates:
Date Received: June 12, 2012
Date Started: May 2013
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017