Study of REN-1654 in Patients With Sciatica Pain

NCT00107055 | Unknown Phase 2

• 1 other identifier: REN-1654-2-03
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 19

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.

Conditions

Sciatica; Herniated Disc; Radiculopathy

Keywords

Herniated nucleus pulposus; Lumbosacral radiculopathy; Anti-TNF alpha; Tumor necrosis factor alpha

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

• 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

Interventions

REN-1654 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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 .

Sponsors & Collaborators

• Renovis: lead

Study Sites (19)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Advanced Clinical Therapeutics, LLC

Tuscon, Arizona, 85712, United States

Location

Orthopaedic Spine Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Renstar Medical Research, Inc.

Ocala, Florida, 34471, United States

Location

Suncoast Neuroscience Associates

St. Petersburg, Florida, 33701, United States

Location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

Brigham & Women's Hospital, Pain Trials Center

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine, Pain Management Center

St Louis, Missouri, 63110, United States

Location

A&A Pain Institute of St. Louis

St Louis, Missouri, 63141, United States

Location

Research Across America

New York, New York, 10022, United States

Location

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

The Cleveland Clinic Spine Institute

Cleveland, Ohio, 44195, United States

Location

Lehigh Valley Hospital Neurosciences and Pain Research

Allentown, Pennsylvania, 18103, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Central Texas Spine Institute

Austin, Texas, 78731, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

• 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.

  PMID: 11446385 BACKGROUND

• 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.

  PMID: 12698115 BACKGROUND

MeSH Terms

Conditions

Sciatica; Intervertebral Disc Displacement; Radiculopathy

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Randall W Moreadith, MD, PhD

  Chief Medical Officer, Renovis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2005
• First Posted: April 5, 2005
• Study Start: December 1, 2003
• Study Completion: April 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2005-06

Locations

US (19)