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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01623271
Recruitment Status : Terminated (Due to limited population of research participants.)
First Posted : June 19, 2012
Results First Posted : April 4, 2017
Last Update Posted : July 23, 2020
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome I (CRPS I) Drug: Gabapentin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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 Name: Gralise

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01623271

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
Publications of Results:
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Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01623271    
Other Study ID Numbers: 2012P000466
First Posted: June 19, 2012    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents