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

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.