Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Complex Regional Pain Syndrome I (CRPS I) |
Intervention | Drug: Gabapentin |
Phase | N/A |
Sponsor | Massachusetts General Hospital |
Responsible Party | Massachusetts General Hospital |
ClinicalTrials.gov Identifier | NCT01623271 |
First Received | June 12, 2012 |
Last Updated | December 20, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 12, 2012 |
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Last Updated Date | December 20, 2013 |
Start Date | May 2013 |
Estimated Primary Completion Date | December 2015 |
Current Primary Outcome Measures | Visual Analog Scale (VAS) [Time Frame: 1 year] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise) |
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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 Description | 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Complex Regional Pain Syndrome I (CRPS I) |
Intervention | Drug: Gabapentin Titrating standard dosage for 8 weeks. Other Names: Gralise |
Study Arm (s) | Experimental: Medication titration Medication titration over the first 2 weeks to maximum of 1800mg/day. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 45 |
Estimated Completion Date | December 2015 |
Estimated Primary Completion Date | December 2014 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01623271 |
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Other Study ID Numbers | 2012P000466 |
Has Data Monitoring Committee | No |
Information Provided By | Massachusetts General Hospital |
Study Sponsor | Massachusetts General Hospital |
Collaborators | Not Provided |
Investigators | Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
Massachusetts General Hospital | Boston, Massachusetts, United States, 02114 Contact: Trang T. Vo, B.A. | 617-724-6102 | tvo3@partners.orgPrincipal Investigator: Jianren Mao, M.D., Ph.D. Recruiting |
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