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

NCT01623271 | Terminated Results

• 1 other identifier: 2012P000466
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome I (CRPS I)

Keywords

CRPS I

Outcome Measures

Primary Outcomes (1)

• 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.

  At visit 3

Study Arms (1)

CRPS I Pain Subjects

EXPERIMENTAL

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

Interventions

Gabapentin DRUG

Also known as: Gralise

CRPS I Pain Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• 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.

  PMID: 19628433 RESULT

• 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.

  PMID: 10863041 RESULT

• 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.

  PMID: 20851058 RESULT

• 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.

  PMID: 10568846 RESULT

• 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.

  PMID: 15453912 RESULT

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Problems with recruitment and early termination of the study consequently resulted in uninterpretable data.

Results Point of Contact

• Title: Jianren Mao, MD, PhD
• Organization: Massachusetts General Hospital

jmao@mgh.harvard.edu

617-724-6102

Study Officials

• Jianren Mao, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 23, 2020
• Results First Posted: April 4, 2017

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)