- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167856
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Persistent pain is one of the most common reasons for impaired quality of life following spinal cord injury (SCI). Although numerous interventions are often used to manage neuropathic pain following SCI, most people receive inadequate relief and continue to suffer many years after the original injury. The long-term goal of our pain research is to improve the management of chronic neuropathic pain following SCI.
This study examines the effect of Venlafaxine hydrochloride (VH) in the treatment of chronic neuropathic pain associated with SCI. VH is a second-generation, structurally novel antidepressant medication with a mild side-effect profile compared to these older tricyclic antidepressants (e.g. imipramine and amitriptyline). Previous clinical trials suggest that approximately 60-70% of people with heterogeneous neuropathic pain report at least moderate reductions in pain with older antidepressants. However, reported side-effects have been numerous, and few trials have been conducted on neuropathic pain due to SCI.
The current study is a two-period, 24-week crossover, randomized, placebo-controlled trial. A sample of 60 persons with chronic neuropathic pain and SCI will be randomly assigned to either of two treatment groups (n=30 for each group), in a double-blind fashion. One group will receive VH first and then placebo, whereas the second group will start with the placebo followed by the VH. There will be weekly contacts between the research staff and the study participants to assess pain relief and medication side effects (presence and severity). Several measures of pain intensity, psychosocial well-being, quality of life, and sensory function will be taken throughout the study to examine the effects of VH on neuropathic pain.
We expect that VH will help to relieve neuropathic pain in persons with SCI, and that this decrease in pain intensity will correlate with a reduced psychosocial impact, improved mood, increased participation in daily activities, and increased life satisfaction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Miami, Florida, United States, 33125
- VA Medical Center, Miami
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participant must be able to swallow pills
- fluent in English
- incomplete or complete spinal cord injury
- presence of at least moderately severe neuropathic pain at or below the level of injury
- spinal cord injury at least 2 year prior to entering the study
- pain for at least 6 months prior to entering the study
- spinal cord injury level above L1
- participants on anticonvulsants are considered
- approval of primary physician
Exclusion Criteria:
- pregnant women, or those contemplating pregnancy
- prior history of use of Venlafaxine hydrochloride (Effexor)
- current use of MAOI medications
- persons who have a recent (past year) history of alcohol or drug abuse
- persons with a history of renal disease, heart disease or uncontrolled hypertension, liver disease or hepatic cirrhosis, active major medical or psychiatric illness
- persons with a significant post-traumatic encephalopathy from head trauma sustained at SCI
- persons with tardive dyskinesia or narrow angle glaucoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Venlafaxine HCL (extended release)
|
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other Names:
|
Active Comparator: 2
Benztropine Mesylate
|
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Intensity as measured by subject pain diaries
Time Frame: Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)
|
Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD, VA Medical Center, Miami
Publications and helpful links
General Publications
- Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. doi: 10.1016/S0304-3959(99)00154-2.
- Defrin R, Ohry A, Blumen N, Urca G. Characterization of chronic pain and somatosensory function in spinal cord injury subjects. Pain. 2001 Jan;89(2-3):253-63. doi: 10.1016/s0304-3959(00)00369-9.
- Widerstrom-Noga EG, Felipe-Cuervo E, Yezierski RP. Chronic pain after spinal injury: interference with sleep and daily activities. Arch Phys Med Rehabil. 2001 Nov;82(11):1571-7. doi: 10.1053/apmr.2001.26068.
- Tasmuth T, Hartel B, Kalso E. Venlafaxine in neuropathic pain following treatment of breast cancer. Eur J Pain. 2002;6(1):17-24. doi: 10.1053/eujp.2001.0266.
- Westgren N, Levi R. Quality of life and traumatic spinal cord injury. Arch Phys Med Rehabil. 1998 Nov;79(11):1433-9. doi: 10.1016/s0003-9993(98)90240-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Neuralgia
- Wounds and Injuries
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- B3070-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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