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

Massachusetts General Hospital5 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Interventions

GabapentinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) 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.

Time frame: At visit 3

Data from ClinicalTrials.gov

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