Clinical Management of Neuropathic Pain With Ramelteon - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Takeda Pharmaceuticals North America, Inc.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00753623

Purpose

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.

Condition	Intervention
Neuropathic Pain	Drug: Ramelteon Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Clinical Management of Neuropathic Pain With Ramelteon

Resource links provided by NLM:

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

VAS scores [ Time Frame: Five week study ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.	Drug: Ramelteon ramelteon (8 mg) Other Name: Rozerem
Placebo Comparator: 2 In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.	Drug: Placebo In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm. Other Name: Placebo

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753623

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

Jianren Mao, M.D., Ph. D.

Massachusetts General Hospital

More Information

Additional Information:

MGH Center for Translational Pain Research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jianren Mao, M.D., Ph.D., Dir., MGH Center for Translational Pain Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00753623 History of Changes
Other Study ID Numbers:	2008P-000988
Study First Received:	September 15, 2008
Last Updated:	July 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Pain
Neuropathic pain
Pain scores

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases

Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012