Clinical Management of Neuropathic Pain With Ramelteon
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Ramelteon (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Jianren Mao, M.D., Ph. D., Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Mary Houghton, B.A., Phone: 617-726-3744, Email: mhoughton1@partners.org
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.
Clinical Details
Official title: Clinical Management of Neuropathic Pain With Ramelteon
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: VAS scores
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mary Houghton, B.A., Phone: 617-726-3744, Email: mhoughton1@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Mary M. Houghton, BA, Phone: 617-726-3744, Email: mhoughton1@partners.org
Charlene Malarick, RN, Phone: 617-724-0253, Email: cmalarick@partners.org
Jianren Mao, M..D., Ph.D., Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Mary M. Houghton, BA, Phone: 617-726-3744, Email: mhoughton1@partners.org
Charlene Malarick, RN, Phone: 617-724-0253, Email: cmalarick@partners.org
Additional Information
MGH Center for Translational Pain Research
Starting date: September 2008
Ending date: August 2009
Last updated: July 9, 2009
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