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

Primary Purpose

Complex Regional Pain Syndrome I (CRPS I)

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gabapentin

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome I (CRPS I) focused on measuring CRPS I

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject will be between 18 to 80 years of age.
Subject has not been on Gralise.
Subject has not been on gabapentin for at least one month.
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.
Subject has a VAS pain score of 5 or above at the beginning of the study.
Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

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.)
Subject has pending litigation related to his/her CRPS I condition.
Subject is pregnant or lactating.
Subject is allergic to gabapentin or Gralise.
Subject has a positive urine (illicit) drug test.
Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRPS I Pain Subjects

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01623271

First Posted

June 12, 2012

Last Updated

July 21, 2020

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01623271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Due to limited population of research participants.

Study Start Date

May 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Regional Pain Syndrome I (CRPS I)

Keywords

CRPS I

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CRPS I Pain Subjects

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Gralise

Primary Outcome Measure Information:

Title

Visual Analog Scale (VAS) at Visit 3

Description

Time Frame

At visit 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject will be between 18 to 80 years of age. Subject has not been on Gralise. Subject has not been on gabapentin for at least one month. 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. Subject has a VAS pain score of 5 or above at the beginning of the study. Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation. Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit. Exclusion Criteria: 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.) Subject has pending litigation related to his/her CRPS I condition. Subject is pregnant or lactating. Subject is allergic to gabapentin or Gralise. Subject has a positive urine (illicit) drug test. Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history. Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianren Mao, M.D., Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19628433

Citation

Mao J. Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. doi: 10.1016/j.jpain.2009.06.002. Epub 2009 Jul 22.

Results Reference

result

PubMed Identifier

10863041

Citation

Mao J, Chen LL. Systemic lidocaine for neuropathic pain relief. Pain. 2000 Jul;87(1):7-17. doi: 10.1016/S0304-3959(00)00229-3.

Results Reference

result

PubMed Identifier

20851058

Citation

Mao J, Gold MS, Backonja MM. Combination drug therapy for chronic pain: a call for more clinical studies. J Pain. 2011 Feb;12(2):157-66. doi: 10.1016/j.jpain.2010.07.006. Epub 2010 Sep 17.

Results Reference

result

PubMed Identifier

10568846

Citation

Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. doi: 10.1016/S0304-3959(99)00154-2.

Results Reference

result

PubMed Identifier

15453912

Citation

van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]. BMC Neurol. 2004 Sep 29;4:13. doi: 10.1186/1471-2377-4-13.

Results Reference

result

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

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