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Study of REN-1654 in Patients With Sciatica Pain

Primary Purpose

Sciatica, Herniated Disc, Radiculopathy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REN-1654
Sponsored by
Renovis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Sciatica focused on measuring Herniated nucleus pulposus, Lumbosacral radiculopathy, Anti-TNF alpha, Tumor necrosis factor alpha

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females, ages 18 to 55, able and willing to provide written informed consent to participate in the study. Able to read, understand and follow the study instructions, including completion of pain intensity rating scales. Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment. Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 24 hour period) of at least 4, using an 11-point categorical pain intensity scale with 0 = no pain and 10 = worst pain imaginable. Leg pain on a screening Categorical Pain Intensity Rating rated as more severe than back pain. Positive straight leg raising (SLR) test as defined in Appendix B of this protocol. Subjects who are compliant in maintaining a Pain Diary between screening and baseline visits, and who record a 24-hour average Categorical Pain Intensity Rating score of at least 4 or greater on at least 3 days during the week prior to baseline visit. Subject who can maintain stable pharmacologic treatments for sciatica symptoms taken prior to dosing including analgesics, anti-inflammatory medications (e.g. NSAIDS), antidepressants, anticonvulsants, anxiolytics, or muscle relaxants. Subjects must be on stable doses of such medications for 2 weeks prior to the baseline visit, and maintained on the same doses throughout the study. Medications taken on an as-needed basis are permitted, and subjects will be asked to record daily usage of such medications in the subject diary. Subjects who at screening are receiving adjunctive analgesic therapy such as acupuncture or biofeedback should either discontinue it or establish a schedule of treatments that will remain consistent for 2 weeks prior to the baseline visit, and throughout the study. Subject with screening laboratory values within normal limits, or if abnormal must be considered not clinically significant and in the opinion of the Investigator not to place the subjects at risk. If female, must be post-menopausal, surgically sterile, not currently pregnant (verified by a screening pregnancy test) or nursing, and using a reliable contraception method such as intrauterine device (IUD), hormonal birth control pills, or double barrier method (male condom, female condom or diaphragm with spermicidal jelly). If male, must agree to use double-barrier methods of contraception. Exclusion Criteria: History of peripheral neuropathy or any other pain conditions with pain intensity equal to or greater than the pain associated with sciatica. Motor loss in a muscle corresponding to the affected dermatome graded as more than "trace". History of cauda equina syndrome, symptomatic scoliosis, spondylolisthesis (degenerative or isthmic), ankylosing spondylitis, rheumatoid arthritis or other inflammatory arthropathies. Degenerative arthritis is allowed. History of hepatic, cardiovascular, renal, gastrointestinal, hematological, neurological, endocrine (including diabetes), metabolic, pulmonary, immunological (including HIV infection) or psychiatric disease that in the opinion of the Investigator would pose a significant safety risk for a subject exposed to an investigational compound such as REN-1654. History of the following ophthalmic disorders based upon general medical review at the screening visit. Subjects will further undergo a screening ophthalmologic assessment. Should any of the following be identified at the screening ophthalmologic examination, the subject will be excluded from the study. Symptomatic cataract, resulting in any visual impairment (if a subject has been diagnosed with cataract to a degree that the cataract interferes with daily living and/or regarding which an ophthalmologist has recommended cataract surgery); Other vision-impairing disorders (if a subject is aware of any eye disorder that has impaired vision, such as age-related macular degeneration, lazy eye (amblyopia), double vision, or any optic nerve inflammation; presbyopia and other non-pathological visual acuity deficits are not exclusionary); Glaucoma or history of ocular hypertension (intraocular pressures greater than 21 mmHg). Cognitive or psychiatric disorders that may diminish compliance with study procedures, including maintenance of a daily pain diary and accurate dosing of study medication. Subjects who, at time of enrollment, have requested for or been advised by their physicians to receive local, regional, or spinal (articular, epidural, intrathecal or nerve root block) injections of medications for pain treatment or surgical intervention for their sciatica symptoms. Although subjects who report work-related injuries will be allowed to enroll, subjects will be excluded if they are involved in litigation related to the current episode of sciatica. Subjects with a screening creatinine laboratory value of ≥ 2.0 mg/dL. Screening liver enzyme results greater than the upper limit of the normal range Use of chemotherapy agents or history of cancer, other than basal cell carcinoma and squamous cell carcinoma, within five years prior to the screening visit. History of drug or alcohol abuse within one year prior to screening. Use within 2 weeks before start of study investigational compound dosing at baseline and through the end of the study of any investigational compound, any epidural, intrathecal, or nerve root block agent, corticosteroids, etanercept or other anti-TNF-α agent, topical anesthetics, or topical analgesics . Previous participation in another REN-1654 study.

Sites / Locations

  • Alabama Clinical Therapeutics
  • Advanced Clinical Therapeutics, LLC
  • Orthopaedic Spine Center at Stanford University Medical Center
  • Mile High Research Center
  • Clinical Research of West Florida
  • Renstar Medical Research, Inc.
  • Suncoast Neuroscience Associates
  • Emory Orthopaedics and Spine Center
  • Brigham & Women's Hospital, Pain Trials Center
  • Washington University School of Medicine, Pain Management Center
  • A&A Pain Institute of St. Louis
  • Research Across America
  • Asheville Neurology Specialists, PA
  • Wake Research Associates
  • The Cleveland Clinic Spine Institute
  • Lehigh Valley Hospital Neurosciences and Pain Research
  • Omega Medical Research
  • Central Texas Spine Institute
  • Advanced Clinical Research

Outcomes

Primary Outcome Measures

Leg Pain: Change in Average Daily 11-Point Categorical Pain Intensity Rating at the end of the 3-week treatment period

Secondary Outcome Measures

Initiation of the following clinical interventions and time to intervention, if elected, through the 3-week treatment period and 3-week post treatment follow-up period:
[1] Local, regional, or spinal (articular, epidural, intrathecal, or nerve root block) injections of medications for pain treatment. [2] Surgery for treatment of sciatica symptoms
Use of concomitant analgesic medications (tracked by daily log of medication usage)
Back Pain: Change in Average Daily Categorical Pain Intensity
Leg Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity Rating
Back Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity
Change in Oswestry Low Back Disability Questionnaire; Change in Straight Leg Raising test
Change in muscle weakness
Change in sensory deficit
Change in tendon reflexes
Global impression of change: subject and investigator

Full Information

First Posted
April 4, 2005
Last Updated
June 23, 2005
Sponsor
Renovis
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1. Study Identification

Unique Protocol Identification Number
NCT00107055
Brief Title
Study of REN-1654 in Patients With Sciatica Pain
Official Title
REN-1654 in Sciatica: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study in Subjects With Pain Due to Lumbosacral Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Renovis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that is causing compression on the nerves coming out of the spinal column.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study to determine the efficacy and tolerability of REN-1654 in subjects with sciatica. After screening and baseline clinical assessments, subjects will be randomly assigned to receive REN 1654 100 mg or matching placebo, once daily for 3 weeks. Leg pain, back pain and other efficacy measures will be assessed at 1 and 3 weeks after initiation of treatment. A subset of patients will undergo analysis of blood levels of REN-1654 during the course of the study (pharmacokinetics). Subjects will discontinue treatment after 3 weeks and return after a further 3 weeks off therapy for a final clinical assessment 6 weeks after initiation of treatment. If a subject does not return for follow-up, an effort will be made by telephone to document their clinical status and whether other interventions have been made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica, Herniated Disc, Radiculopathy
Keywords
Herniated nucleus pulposus, Lumbosacral radiculopathy, Anti-TNF alpha, Tumor necrosis factor alpha

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
REN-1654
Primary Outcome Measure Information:
Title
Leg Pain: Change in Average Daily 11-Point Categorical Pain Intensity Rating at the end of the 3-week treatment period
Secondary Outcome Measure Information:
Title
Initiation of the following clinical interventions and time to intervention, if elected, through the 3-week treatment period and 3-week post treatment follow-up period:
Title
[1] Local, regional, or spinal (articular, epidural, intrathecal, or nerve root block) injections of medications for pain treatment. [2] Surgery for treatment of sciatica symptoms
Title
Use of concomitant analgesic medications (tracked by daily log of medication usage)
Title
Back Pain: Change in Average Daily Categorical Pain Intensity
Title
Leg Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity Rating
Title
Back Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity
Title
Change in Oswestry Low Back Disability Questionnaire; Change in Straight Leg Raising test
Title
Change in muscle weakness
Title
Change in sensory deficit
Title
Change in tendon reflexes
Title
Global impression of change: subject and investigator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, ages 18 to 55, able and willing to provide written informed consent to participate in the study. Able to read, understand and follow the study instructions, including completion of pain intensity rating scales. Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment. Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 24 hour period) of at least 4, using an 11-point categorical pain intensity scale with 0 = no pain and 10 = worst pain imaginable. Leg pain on a screening Categorical Pain Intensity Rating rated as more severe than back pain. Positive straight leg raising (SLR) test as defined in Appendix B of this protocol. Subjects who are compliant in maintaining a Pain Diary between screening and baseline visits, and who record a 24-hour average Categorical Pain Intensity Rating score of at least 4 or greater on at least 3 days during the week prior to baseline visit. Subject who can maintain stable pharmacologic treatments for sciatica symptoms taken prior to dosing including analgesics, anti-inflammatory medications (e.g. NSAIDS), antidepressants, anticonvulsants, anxiolytics, or muscle relaxants. Subjects must be on stable doses of such medications for 2 weeks prior to the baseline visit, and maintained on the same doses throughout the study. Medications taken on an as-needed basis are permitted, and subjects will be asked to record daily usage of such medications in the subject diary. Subjects who at screening are receiving adjunctive analgesic therapy such as acupuncture or biofeedback should either discontinue it or establish a schedule of treatments that will remain consistent for 2 weeks prior to the baseline visit, and throughout the study. Subject with screening laboratory values within normal limits, or if abnormal must be considered not clinically significant and in the opinion of the Investigator not to place the subjects at risk. If female, must be post-menopausal, surgically sterile, not currently pregnant (verified by a screening pregnancy test) or nursing, and using a reliable contraception method such as intrauterine device (IUD), hormonal birth control pills, or double barrier method (male condom, female condom or diaphragm with spermicidal jelly). If male, must agree to use double-barrier methods of contraception. Exclusion Criteria: History of peripheral neuropathy or any other pain conditions with pain intensity equal to or greater than the pain associated with sciatica. Motor loss in a muscle corresponding to the affected dermatome graded as more than "trace". History of cauda equina syndrome, symptomatic scoliosis, spondylolisthesis (degenerative or isthmic), ankylosing spondylitis, rheumatoid arthritis or other inflammatory arthropathies. Degenerative arthritis is allowed. History of hepatic, cardiovascular, renal, gastrointestinal, hematological, neurological, endocrine (including diabetes), metabolic, pulmonary, immunological (including HIV infection) or psychiatric disease that in the opinion of the Investigator would pose a significant safety risk for a subject exposed to an investigational compound such as REN-1654. History of the following ophthalmic disorders based upon general medical review at the screening visit. Subjects will further undergo a screening ophthalmologic assessment. Should any of the following be identified at the screening ophthalmologic examination, the subject will be excluded from the study. Symptomatic cataract, resulting in any visual impairment (if a subject has been diagnosed with cataract to a degree that the cataract interferes with daily living and/or regarding which an ophthalmologist has recommended cataract surgery); Other vision-impairing disorders (if a subject is aware of any eye disorder that has impaired vision, such as age-related macular degeneration, lazy eye (amblyopia), double vision, or any optic nerve inflammation; presbyopia and other non-pathological visual acuity deficits are not exclusionary); Glaucoma or history of ocular hypertension (intraocular pressures greater than 21 mmHg). Cognitive or psychiatric disorders that may diminish compliance with study procedures, including maintenance of a daily pain diary and accurate dosing of study medication. Subjects who, at time of enrollment, have requested for or been advised by their physicians to receive local, regional, or spinal (articular, epidural, intrathecal or nerve root block) injections of medications for pain treatment or surgical intervention for their sciatica symptoms. Although subjects who report work-related injuries will be allowed to enroll, subjects will be excluded if they are involved in litigation related to the current episode of sciatica. Subjects with a screening creatinine laboratory value of ≥ 2.0 mg/dL. Screening liver enzyme results greater than the upper limit of the normal range Use of chemotherapy agents or history of cancer, other than basal cell carcinoma and squamous cell carcinoma, within five years prior to the screening visit. History of drug or alcohol abuse within one year prior to screening. Use within 2 weeks before start of study investigational compound dosing at baseline and through the end of the study of any investigational compound, any epidural, intrathecal, or nerve root block agent, corticosteroids, etanercept or other anti-TNF-α agent, topical anesthetics, or topical analgesics . Previous participation in another REN-1654 study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall W Moreadith, MD, PhD
Organizational Affiliation
Chief Medical Officer, Renovis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orthopaedic Spine Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Renstar Medical Research, Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Suncoast Neuroscience Associates
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Brigham & Women's Hospital, Pain Trials Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University School of Medicine, Pain Management Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
A&A Pain Institute of St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Cleveland Clinic Spine Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lehigh Valley Hospital Neurosciences and Pain Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Central Texas Spine Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11446385
Citation
Sommer C, Schafers M, Marziniak M, Toyka KV. Etanercept reduces hyperalgesia in experimental painful neuropathy. J Peripher Nerv Syst. 2001 Jun;6(2):67-72. doi: 10.1046/j.1529-8027.2001.01010.x.
Results Reference
background
PubMed Identifier
12698115
Citation
Karppinen J, Korhonen T, Malmivaara A, Paimela L, Kyllonen E, Lindgren KA, Rantanen P, Tervonen O, Niinimaki J, Seitsalo S, Hurri H. Tumor necrosis factor-alpha monoclonal antibody, infliximab, used to manage severe sciatica. Spine (Phila Pa 1976). 2003 Apr 15;28(8):750-3; discussion 753-4.
Results Reference
background

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Study of REN-1654 in Patients With Sciatica Pain

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