Overview

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

Status:
Unknown status
Trial end date:
2004-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Renovis
Criteria
Inclusion Criteria:

1. Males or females, aged 55 years or older, able and willing to provide written informed
consent to participate in the study.

2. Able to read, understand and follow the study instructions, including completion of
pain intensity rating scales.

3. 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.

4. 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".

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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).

12. If male, must agree to use double-barrier methods of contraception.

Exclusion Criteria:

1. History of peripheral neuropathy or any chronic pain condition other than PHN.

2. 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.

3. 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).

- Glaucoma or history of ocular hypertension (intraocular pressures greater than 21
mm Hg).

4. Cognitive or psychiatric disorders that may diminish compliance with study procedures,
including maintenance of a daily pain diary and accurate dosing of study medication.

5. 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).

6. Serum creatinine ≥ 2 mg/dL at screening

7. 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.

8. History of drug or alcohol abuse within one year prior to screening.

9. 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.