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

NCT ID: NCT01435798

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-01-31

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.

Conditions

Central Neuropathic Pain; Allodynia; Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0% MTD Dex

0% MTD Dextromethorphan

Group Type: PLACEBO_COMPARATOR

Dextromethorphan

Intervention Type: DRUG

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

25% MTD Dex

25% MTD Dextromethorphan

Group Type: EXPERIMENTAL

Dextromethorphan

Intervention Type: DRUG

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

50% MTD Dex

50% MTD Dextromethorphan

Group Type: EXPERIMENTAL

Dextromethorphan

Intervention Type: DRUG

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

100% MTD Dex

100% MTD Dextromethorphan

Group Type: EXPERIMENTAL

Dextromethorphan

Intervention Type: DRUG

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

Interventions

Dextromethorphan

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions

3. 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.

4. Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.

5. Normal cognitive function.

6. Normal communicative ability (English).

7. Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.

8. Signed informed consent.

Exclusion Criteria

1. Pregnancy or breast-feeding.

2. Renal or hepatic dysfunction.

3. Significant cardiac disease (e.g. MI within 1 year).

4. Signs or symptoms of central neurological disorder, excluding SCI.

5. Severe psychological disorder requiring treatment.

6. Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.

7. Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.

8. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.

9. Chronic substance abuse, including alcohol.

10. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.

11. Poor metabolizer of P450 2D6 substrates.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christine N. Sang, MD, MPH

Director, Translational Pain Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine N. Sang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Related Links

http://www.paintrials.org

Translational Pain Research, Brigham and Women's Hospital

Other Identifiers

R01NS041503

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000p001387-A

Identifier Type: -

Identifier Source: org_study_id