RN624 For Pain Of Post-Herpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568321
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : October 23, 2009
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Brief Summary:
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: RN624 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Proof Of Concept Study Of The Analgesic Effects Of RN624 In Adult Patients With Post-Herpetic Neuralgia
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: 1 Drug: RN624
50 mcg/kg

Active Comparator: 2 Drug: RN624
200 mcg/kg

Placebo Comparator: 3 Drug: Placebo

Primary Outcome Measures :
  1. The primary endpoint is the change from Baseline to Week 6 in average daily pain as measured by an 11-point Numeric Rating Scale (NRS) derived from the patient daily diary. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ]
  2. The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ]
  3. Secondary endpoints will examine change from Baseline for various domains of pain, and pain interference with function, using the modified Brief Pain Inventory-short form and various definitions of responder status based on the patient daily diary. [ Time Frame: 16 weeks ]
  4. Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ]
  5. Other secondary endpoints will examine change from Baseline in the Patient's Global Assessment of Pain from Post-herpetic Neuralgia (disease activity) score and the Patient's Global Evaluation of Study Medication (treatment response) [ Time Frame: 16 weeks ]
  6. score. [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female of any race, at least 18 years of age.
  • Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
  • Has a pain score at screening that qualifies.
  • Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
  • Body Mass Index less than or equal to 39 kg/m2.
  • If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
  • Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Patients must consent in writing to participate in the study.

Exclusion Criteria:

  • Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
  • Disqualifying scores on questionnaires.
  • Other moderate to severe pain from other conditions.
  • History of allergic or anaphylactic reaction to antibodies.
  • Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
  • Unable to use acetaminophen.
  • Disqualify laboratory values, Hepatitis B or C or HIV.
  • Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
  • Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
  • Cancer other than basal cell or squamous cell carcinoma.
  • Fails a urine test for illegal drugs including prescription drugs without a prescription.
  • Plans for surgery during the study.
  • History of alcoholism or drug abuse in the past two years.
  • Surgery for post-herpetic neuralgia.
  • Any condition that the investigator feels would put the safety of the patient at risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568321

  Show 27 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00568321     History of Changes
Other Study ID Numbers: A4091005
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
monoclonal antibody

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms