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Clinical Management of Neuropathic Pain With Ramelteon

Primary Purpose

Neuropathic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Pain, Neuropathic pain, Pain scores

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject will be between ages 18 to 65 years.
  2. Subject has not been on ramelteon for at least one month.
  3. Subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
  4. Subject has a VAS pain score of 5 or above at the beginning of the study.
  5. Subject has had a neuropathic pain condition as listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
  6. Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

  1. Subject has moderate to severe liver impairment.
  2. Subject has Liver Function Tests (LFT's) >1.5X normal.
  3. Subject has a history of renal impairment.
  4. Subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen.
  5. Subject has a history of glaucoma.
  6. Subject has obstructive sleep apnea.
  7. Subject is taking medications for sleep disorders including insomnia.
  8. Subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse).
  9. Subject has a history of dementia or delirium.
  10. Subject has a history of falls.
  11. Subject is pregnant or lactating.
  12. Subject is using an illicit drug detected by a screening test.
  13. Subject is currently taking Fluvoxamine.
  14. Subject has been taking Ketoconazole in the past two weeks.
  15. Subject has known hypersensitivity to ramelteon.
  16. Subject has pending litigation related to his/her neuropathic pain condition.
  17. Subject has Concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ramelteon first, placebo second

Placebo first, ramelteon second

Arm Description

In a crossover design, a subject will be first assigned to the ramelteon arm and then switched over to the placebo arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night.The ramelteon and placebo will be blinded by the central pharmacy. The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.

In a crossover design, a subject will be first assigned to the placebo arm and then switched over to the ramelteon arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night. The ramelteon and placebo will be blinded by the central pharmacy. The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.

Outcomes

Primary Outcome Measures

Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments
Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2008
Last Updated
April 3, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Takeda Pharmaceuticals North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00753623
Brief Title
Clinical Management of Neuropathic Pain With Ramelteon
Official Title
Clinical Management of Neuropathic Pain With Ramelteon
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment did not accrue as expected.
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.
Detailed Description
Neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. Despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. To date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. We propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon [a melatonin (MT) 1/ MT2 receptor agonist] on neuropathic pain. We hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Pain, Neuropathic pain, Pain scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramelteon first, placebo second
Arm Type
Active Comparator
Arm Description
In a crossover design, a subject will be first assigned to the ramelteon arm and then switched over to the placebo arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night.The ramelteon and placebo will be blinded by the central pharmacy. The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
Arm Title
Placebo first, ramelteon second
Arm Type
Placebo Comparator
Arm Description
In a crossover design, a subject will be first assigned to the placebo arm and then switched over to the ramelteon arm. As this is a double-blind study, neither the subject nor the study staff will know which intervention the subject is randomly assigned. The ramelteon dose is 8mg once a night. The ramelteon and placebo will be blinded by the central pharmacy. The subject is randomly assigned to first receive either ramelteon or placebo. The first intervention will be 14 days long. There is a 7 day washout period, and then the subject is assigned to the opposite intervention. The second intervention will be 14 days long.
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
ramelteon (8 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.
Primary Outcome Measure Information:
Title
Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments
Description
Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.
Time Frame
VAS score at baseline and after the treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject will be between ages 18 to 65 years. Subject has not been on ramelteon for at least one month. Subject agrees to make no change in his/her current pain medications during the entire study period (5 weeks). This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study. Subject has a VAS pain score of 5 or above at the beginning of the study. Subject has had a neuropathic pain condition as listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation. Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit. Exclusion Criteria: Subject has moderate to severe liver impairment. Subject has Liver Function Tests (LFT's) >1.5X normal. Subject has a history of renal impairment. Subject has moderate or severe cardiac or pulmonary disease including a base line oxygen saturation of less than 95% on room air or any requirement for supplemental oxygen. Subject has a history of glaucoma. Subject has obstructive sleep apnea. Subject is taking medications for sleep disorders including insomnia. Subject has a major psychiatric disorder (major depression requiring a recent hospitalization within three months prior to the study; bipolar disorder; schizophrenia; psychotic disorders; substance abuse). Subject has a history of dementia or delirium. Subject has a history of falls. Subject is pregnant or lactating. Subject is using an illicit drug detected by a screening test. Subject is currently taking Fluvoxamine. Subject has been taking Ketoconazole in the past two weeks. Subject has known hypersensitivity to ramelteon. Subject has pending litigation related to his/her neuropathic pain condition. Subject has Concurrent participation in other research drug trials or other study participation within 30 days of enrollment in this study.
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
No

Learn more about this trial

Clinical Management of Neuropathic Pain With Ramelteon

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