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SciaticaPhase 2NCT00107055

Study of REN-1654 in Patients With Sciatica Pain

A Phase 2 study testing REN-1654 in people with Sciatica and Herniated Disc, run by Renovis at 19 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Sciatica, Herniated Disc, Radiculopathy
What is being tested?
REN-1654
How many people
72 participants
Where
19 sitesUnited States
Study dates
Dec 2003to Apr 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Lehigh Valley Hospital Neurosciences and Pain Research

    Allentown, Pennsylvania, 18103

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Emory Orthopaedics and Spine Center

    Atlanta, Georgia, 30329

  • Central Texas Spine Institute

    Austin, Texas, 78731

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Brigham & Women's Hospital, Pain Trials Center

    Boston, Massachusetts, 02115

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • The Cleveland Clinic Spine Institute

    Cleveland, Ohio, 44195

  • Mile High Research Center

    Denver, Colorado, 80218

  • Research Across America

    New York, New York, 10022

  • Renstar Medical Research, Inc.

    Ocala, Florida, 34471

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Washington University School of Medicine, Pain Management Center

    St Louis, Missouri, 63110

  • A&A Pain Institute of St. Louis

    St Louis, Missouri, 63141

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33701

  • Orthopaedic Spine Center at Stanford University Medical Center

    Stanford, California, 94305

  • Advanced Clinical Therapeutics, LLC

    Tuscon, Arizona, 85712

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Advanced Clinical Research

    West Jordan, Utah, 84088

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
REN-1654
Keywords
Herniated nucleus pulposus, Lumbosacral radiculopathy, Anti-TNF alpha, Tumor necrosis factor alpha
Medical subject headings
Sciatica, Intervertebral Disc Displacement, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REN-1654Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. 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:

  2. [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

  3. Use of concomitant analgesic medications (tracked by daily log of medication usage)

  4. Back Pain: Change in Average Daily Categorical Pain Intensity

  5. Leg Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity Rating

  6. Back Pain: Change in Maximum (or movement-induced) Daily Categorical Pain Intensity

  7. Change in Oswestry Low Back Disability Questionnaire; Change in Straight Leg Raising test

  8. Change in muscle weakness

  9. Change in sensory deficit

  10. Change in tendon reflexes

  11. Global impression of change: subject and investigator

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2005 (estimated)
  2. Study startDec 2003
  3. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
72 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107055
Sponsor's protocol ID
REN-1654-2-03
Status last verified
Jun 2005
First submitted
4 Apr 2005
Last updated
24 Jun 2005
Results posted
No

Publications

  • 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.

    PubMed 11446385

  • 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.

    PubMed 12698115

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REN-1654 in people with Sciatica and Herniated Disc, run by Renovis at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg Pain: Change in Average Daily 11-Point Categorical Pain Intensity Rating at the end of the 3-week treatment period. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00107055, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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