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

July 21, 2020 updated by: Jianren Mao, MD, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRPS I Pain Subjects

This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.

Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Drug: Gabapentin
Other Names:
  • Gralise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) at Visit 3
Time Frame: 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.
At visit 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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