Back to results

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

Primary Purpose

Central Neuropathic Pain, Allodynia, Spinal Cord Injury

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dextromethorphan

About this trial

This is an interventional treatment trial for Central Neuropathic Pain focused on measuring chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
Serum laboratory examination obtained at study entry:
- Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
- For women of childbearing age: negative serum beta HCG.
Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
Normal cognitive function.
Normal communicative ability (English).
Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
Signed informed consent.

Exclusion Criteria:

Pregnancy or breast-feeding.
Renal or hepatic dysfunction.
Significant cardiac disease (e.g. MI within 1 year).
Signs or symptoms of central neurological disorder, excluding SCI.
Severe psychological disorder requiring treatment.
Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
Chronic substance abuse, including alcohol.
Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
Poor metabolizer of P450 2D6 substrates.

Sites / Locations

Translational Pain Research, Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

0% MTD Dex

25% MTD Dex

50% MTD Dex

100% MTD Dex

Arm Description

0% MTD Dextromethorphan

25% MTD Dextromethorphan

50% MTD Dextromethorphan

100% MTD Dextromethorphan

Outcomes

Primary Outcome Measures

Mean Pain Intensity (Percent Change From Baseline)

Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.

Secondary Outcome Measures

Satisfaction

Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)

Full Information

NCT ID

NCT01435798

First Posted

September 15, 2011

Last Updated

February 15, 2017

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01435798

Brief Title

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

Official Title

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Neuropathic Pain, Allodynia, Spinal Cord Injury

Keywords

chronic pain, central neuropathic pain, spinal cord injury, dextromethorphan, lidocaine, combination therapy, analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0% MTD Dex

Arm Type

Placebo Comparator

Arm Description

0% MTD Dextromethorphan

Arm Title

25% MTD Dex

Arm Type

Experimental

Arm Description

25% MTD Dextromethorphan

Arm Title

50% MTD Dex

Arm Type

Experimental

Arm Description

50% MTD Dextromethorphan

Arm Title

100% MTD Dex

Arm Type

Experimental

Arm Description

100% MTD Dextromethorphan

Intervention Type

Drug

Intervention Name(s)

Dextromethorphan

Intervention Description

0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period

Primary Outcome Measure Information:

Title

Mean Pain Intensity (Percent Change From Baseline)

Description

Time Frame

1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)

Secondary Outcome Measure Information:

Title

Satisfaction

Description

Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)

Time Frame

Last week prior to admission (end of 1-week maintenance period)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions Serum laboratory examination obtained at study entry: Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal). For women of childbearing age: negative serum beta HCG. Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control. Normal cognitive function. Normal communicative ability (English). Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires. Signed informed consent. Exclusion Criteria: Pregnancy or breast-feeding. Renal or hepatic dysfunction. Significant cardiac disease (e.g. MI within 1 year). Signs or symptoms of central neurological disorder, excluding SCI. Severe psychological disorder requiring treatment. Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry. Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers. History of hypersensitivity or intolerance to dextromethorphan or lidocaine. Chronic substance abuse, including alcohol. Participation in a study of an investigational drug or device within 30 days prior to screening for this study. Poor metabolizer of P450 2D6 substrates.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine N. Sang, MD, MPH

Organizational Affiliation

Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Translational Pain Research, Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.paintrials.org

Description

Translational Pain Research, Brigham and Women's Hospital

Learn more about this trial

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

We'll reach out to this number within 24 hrs