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Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
This study has been completed.
Sponsor:
Brigham and Women's Hospital
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01435798
First received: September 15, 2011
Last updated: February 15, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Central Neuropathic Pain Allodynia Spinal Cord Injury | Drug: Dextromethorphan | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Christine N. Sang, MD, MPH, Brigham and Women's Hospital:
Primary Outcome Measures:
- Mean Pain Intensity (Percent Change From Baseline) [ 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) ]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 [ Time Frame: Last week prior to admission (end of 1-week maintenance period) ]Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)
| Enrollment: | 26 |
| Study Start Date: | April 2003 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 0% MTD Dex
0% MTD Dextromethorphan
|
Drug: Dextromethorphan
0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
|
|
Experimental: 25% MTD Dex
25% MTD Dextromethorphan
|
Drug: Dextromethorphan
0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
|
|
Experimental: 50% MTD Dex
50% MTD Dextromethorphan
|
Drug: Dextromethorphan
0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
|
|
Experimental: 100% MTD Dex
100% MTD Dextromethorphan
|
Drug: Dextromethorphan
0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435798
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435798
Locations
| United States, Massachusetts | |
| Translational Pain Research, Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Christine N. Sang, MD, MPH | Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent) |
More Information
Additional Information:
| Responsible Party: | Christine N. Sang, MD, MPH, Director, Translational Pain Research, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01435798 History of Changes |
| Other Study ID Numbers: |
R01NS041503 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | September 15, 2011 |
| Results First Received: | June 26, 2014 |
| Last Updated: | February 15, 2017 |
Keywords provided by Christine N. Sang, MD, MPH, Brigham and Women's Hospital:
|
chronic pain central neuropathic pain spinal cord injury dextromethorphan |
lidocaine combination therapy analgesia |
Additional relevant MeSH terms:
|
Wounds and Injuries Spinal Cord Injuries Neuralgia Hyperalgesia Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Pain Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases |
Signs and Symptoms Somatosensory Disorders Sensation Disorders Dextromethorphan Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017