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NeuralgiaPhase 2NCT00099528

Dose-Finding Study of REN-1654 in Patients With Post-Herpetic Neuralgia

A Phase 2 study testing REN-1654 in people with Neuralgia and Shingles, run by Renovis at 16 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 The sponsor has not verified this record for over two years, so it may be out of date.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 painful post-herpetic neuralgia (PHN). Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
REN-1654
How many people
90 participants
Where
16 sitesUnited States
Study dates
Aug 2003to Dec 2004
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, aged 55 years or older, 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.
  • History of herpes zoster cutaneous rash, followed by persistent pain for 2 to 18 months after the onset of the rash until the time of dosing with study medication.
  • A screening Daily Spontaneous Pain Rating (for the prior 24-hour period) of at least 4, using an 11-point categorical pain intensity scale with 0 as "no pain" and 10 as "the worst pain imaginable".
  • A positive (non-zero) Evoked Allodynia score reported at the time of screening using the categorical pain intensity scale in response to at least one of two stimuli: light stroking with a foam brush, or #14 von Frey hair stimulation.
  • Subjects who are compliant in maintaining a Pain Diary between the screening and baseline visits, and who record a Daily Spontaneous Pain Rating score of 4 or greater on at least 3 days during the week prior to the baseline visit.
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  • Subjects who at screening are taking analgesics, antidepressants, anticonvulsants, anxiolytics, or muscle relaxants, must have been on each such medication for 4 weeks, and at stable doses for 2 weeks prior to the baseline visit, and must be maintained on the same doses throughout the study.
  • 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.
  • Subjects who agree to discontinue topical pain treatments at least 2 weeks before the baseline visit, and agree not to use them during the study.
  • Subjects who agree that they will not receive local, regional or spinal (articular, epidural, or intrathecal) injections of medication for pain treatments within 2 weeks prior to the baseline visit and through the end of the study.
  • 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 chronic pain condition other than PHN.
  • History of hepatic, cardiovascular, renal, gastrointestinal, hematological, neurological, endocrine (including diabetes), metabolic, pulmonary, immunologic (including HIV) 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, or could significantly diminish the quality of the efficacy data to be collected in the study.
  • History of the following ophthalmic disorders based upon 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;
  • Herpes zoster ophthalmicus involving the eyeball (if a subject has a history of herpes zoster ophthalmicus causing inflammation of any part of the eye [conjunctiva, cornea, iris, retina, optic nerve]; subjects who only had cutaneous herpes zoster involvement of the eyelid without involvement of the eye may be eligible for the study).
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  • Glaucoma or history of ocular hypertension (intraocular pressures greater than 21 mm Hg).
  • Cognitive or psychiatric disorders that may diminish compliance with study procedures, including maintenance of a daily pain diary and accurate dosing of study medication.
  • Screening liver enzyme results greater than the upper limit of the normal range (a value less than one multiple above the upper limit of normal may be acceptable, if approved by the Sponsor before enrollment of the subject).
  • Serum creatinine ≥ 2 mg/dL at screening
  • Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, 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 or intrathecal agent, corticosteroid, antiretroviral, etanercept or other anti-TNF-α agent, topical anesthetics, or topical analgesics.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan Health Center, Dept. Anesthesiology

    Ann Arbor, Michigan, 48109

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Colorado Neurology and Headache Center

    Denver, Colorado, 80218

  • Diagnostic Center of Houston

    Houston, Texas, 77004

  • North Alabama Neuroscience Research Associates

    Huntsville, Alabama, 35801

  • UCSD Center for Pain and Palliative Medicine

    La Jolla, California, 92037

  • Neurophysiologic Laboratory

    Laguna Hills, California, 92653

  • University of Wisconsin at Madison

    Madison, Wisconsin, 53792

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33401

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • HOPE Research Institute

    Phoenix, Arizona, 85032

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • A and A Pain Institute

    St Louis, Missouri, 63141

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33701

  • Advanced Clinical Therapeutics, LLC

    Tuscon, Arizona, 85712

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: REN-1654 in Post-Herpetic Neuralgia: a Multi-Center, Placebo Controlled, 3-week Dose-Finding Study, With a 3-Week Active-Treatment Extension

The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with painful post-herpetic neuralgia (PHN).

Read the detailed description

This is a multi-center, double-blind, randomized, placebo-controlled, dose-finding study. After screening and baseline clinical assessments, subjects will be randomly assigned to receive 30 or 100 mg REN-1654 by mouth (p.o.), or matching placebo, once daily for 3 weeks. After 3 weeks of treatment, the clinical assessments will be repeated. Subjects who complete the 3 week placebo-controlled segment may enter the 3-week active-treatment extension segment, during which subjects in the REN-1654 30 mg group will remain on that dose, subjects who were given placebo in the previous segment will receive REN-1654 100 mg daily, and subjects who received REN 1654 100 mg in the first 3 week study segment will discontinue dosing. Double-blind conditions will be maintained through the placebo-controlled active treatment period (primary efficacy endpoint) and for those continuing dosing into the 3-week second active treatment period. The clinical assessments will be repeated at the end of 6 weeks, after which all subjects will discontinue treatment and return 2 weeks later for the final clinical assessment.

Being tested
REN-1654
Keywords
Post-herpetic neuralgia, Shingles, Herpes Zoster, Neuropathic pain, Neuralgia, Anti-TNF agents, Inflammatory cytokines, Hyperalgesia, Allodynia, Irritable nociceptor
Medical subject headings
Neuralgia, Herpes Zoster, Peripheral Nervous System Diseases, Neuralgia, Postherpetic, Hyperalgesia

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. Change from baseline of the Daily Spontaneous Pain Rating in the most painful area identified at baseline and screening.

Secondary outcomes (5)

  1. (1) Daily Allodynia Rating

  2. (2) Daily Functional Interference Rating for general activity and sleep

  3. (3) Pain Relief Rating (recorded at study visits)

  4. (4) Neuropathic Pain Rating (recorded at study visits)

  5. (5) Evoked Allodynia Rating (recorded at study visits)

Timeline

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

  1. First posted16 Dec 2004 (estimated)
  2. Study startAug 2003
  3. Study completionDec 2004

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099528
Sponsor's protocol ID
REN-1654-2-02
Status last verified
Mar 2005
First submitted
15 Dec 2004
Last updated
29 Jul 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REN-1654 in people with Neuralgia and Shingles, run by Renovis at 16 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 13 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 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Change from baseline of the Daily Spontaneous Pain Rating in the most painful area identified at baseline and screening.. 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 NCT00099528.

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 29 Jul 2010.

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