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

This study is not yet open for participant recruitment.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01623271
First received: June 12, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention
Complex Regional Pain Syndrome I (CRPS I)
 Drug: Gabapentin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment: 45
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication titration
Medication titration over the first 2 weeks to maximum of 1800mg/day.
 Drug: Gabapentin
Titrating standard dosage for 8 weeks.
Other Name: Gralise

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623271

Contacts
Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Contact: Abigail S. Cohen, B.A. 617-724-6102 acohen18@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Trang T. Vo, B.A.     617-724-6102     tvo3@partners.org    
Contact: Abigail S. Cohen, B.A.     617-724-6102     acohen18@partners.org    
Principal Investigator: Jianren Mao, M.D., Ph.D.            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01623271     History of Changes
Other Study ID Numbers: 2012P000466
Study First Received: June 12, 2012
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
CRPS I

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Somatoform Disorders
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 19, 2013