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.
ConditionComplex Regional Pain Syndrome I (CRPS I)
InterventionDrug: Gabapentin
PhaseN/A
SponsorMassachusetts General Hospital
Responsible PartyMassachusetts General Hospital
ClinicalTrials.gov IdentifierNCT01623271
First ReceivedJune 12, 2012
Last UpdatedDecember 20, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 12, 2012
Last Updated DateDecember 20, 2013
Start DateMay 2013
Estimated Primary Completion DateDecember 2015
Current Primary Outcome MeasuresVisual Analog Scale (VAS) [Time Frame: 1 year] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Functional status [Time Frame: 1 year] [Designated as safety issue: Yes]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] [Designated as safety issue: Yes]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] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleTreatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Official TitleTreatment 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 TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionComplex Regional Pain Syndrome I (CRPS I)
InterventionDrug: 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 StatusRecruiting
Estimated Enrollment45
Estimated Completion DateDecember 2015
Estimated Primary Completion DateDecember 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Trang T. Vo, B.A.
617-724-6102
tvo3@partners.org
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01623271
Other Study ID Numbers2012P000466
Has Data Monitoring CommitteeNo
Information Provided ByMassachusetts General Hospital
Study SponsorMassachusetts General Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
Verification DateDecember 2013

Locations[ + expand ][ + ]

Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Trang T. Vo, B.A. | 617-724-6102 | tvo3@partners.org
Principal Investigator: Jianren Mao, M.D., Ph.D.
Recruiting