NCT00167856

Brief Summary

The purpose of this study is to evaluate the pain-relieving effects of venlafaxine hydrochloride (Effexor) in chronic neuropathic (burning, shock-like, electric) pain after spinal cord injury (SCI). Although a number of medications have been used to treat SCI pain, no drug has been consistently helpful, and, therefore, many people with SCI continue to have difficult chronic pain. Venlafaxine is a new anti-depressant drug that has not been tested for use in SCI neuropathic pain, but has been helpful for other types of neuropathic pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 27, 2014

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

September 9, 2005

Last Update Submit

March 26, 2014

Conditions

Neuropathic PainPainSpinal Cord Injuries

Keywords

Burning painClinical trialEffexorPainSpinal cord injuryVenalafaxineNeuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity as measured by subject pain diaries

    Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)

Study Arms (2)

1

EXPERIMENTAL

Venlafaxine HCL (extended release)

Drug: Venalafaxine hydrochloride

2

ACTIVE COMPARATOR

Benztropine Mesylate

Drug: Venalafaxine hydrochloride

Interventions

Venalafaxine hydrochlorideDRUG

Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)

Also known as: Effexor XR
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

Related Publications (5)

  • 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.

    PMID: 10568846RESULT

  • 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.

    PMID: 11166482RESULT

  • 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.

    PMID: 11689978RESULT

  • 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.

    PMID: 11888224RESULT

  • 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.

    PMID: 9821906RESULT

MeSH Terms

Conditions

NeuralgiaPainSpinal Cord Injuries

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Eva G. Widerstrom-Noga, DDS PhD

    VA Medical Center, Miami

    PRINCIPAL INVESTIGATOR

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
FED

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2008

Last Updated

March 27, 2014

Record last verified: 2009-02

Locations

US(1)