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

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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.