Clinical Management of Neuropathic Pain With Ramelteon

NCT00753623 | Terminated Results

• 1 other identifier: 2008P-000988
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Pain; Neuropathic pain; Pain scores

Outcome Measures

Primary Outcomes (1)

• 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.

  VAS score at baseline and after the treatment period

Study Arms (2)

Ramelteon first, placebo second

ACTIVE COMPARATOR

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.

Drug: Ramelteon; Drug: Placebo

Placebo first, ramelteon second

PLACEBO COMPARATOR

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.

Drug: Ramelteon; Drug: Placebo

Interventions

Ramelteon DRUG

ramelteon (8 mg)

Also known as: Rozerem

Placebo first, ramelteon second; Ramelteon first, placebo second

Placebo DRUG

In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.

Placebo first, ramelteon second; Ramelteon first, placebo second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neuralgia; Pain

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Problems with recruitment and termination of the study consequently resulted in uninterpretable data.

Results Point of Contact

• Title: Dr. Jianren Mao
• Organization: MGH Center for Translational Pain Research

mghpainresearch@partners.org

617-724-6102

Study Officials

• Jianren Mao, M.D., Ph. D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 15, 2017
• Results First Posted: July 18, 2014

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)