Clinical trial NCT00568321: RN624 For Pain Of Post-Herpetic Neuralgia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Keywords: monoclonal antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16
measure: Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16
timeFrame: Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16
measure: Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6
timeFrame: Baseline, Week 6
measure: Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6
timeFrame: Baseline, Week 6
measure: Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score
timeFrame: Baseline up to Week 16
measure: Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants
timeFrame: Baseline to Week 16
measure: Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12 and 16
measure: Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8 ,12, 16
measure: Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Number of Participants Who Discontinued the Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Number of Participants Who Used Rescue Medications
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
measure: Duration of Rescue Medication Use
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
measure: Amount of Rescue Medication Taken
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after the last dose of study drug (up to Week 16)
measure: Number of Participants With Abnormal Physical Examinations Findings at Screening
timeFrame: Screening visit (1 day prior to Day 1 baseline visit)
measure: Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Response
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study
timeFrame: Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab
timeFrame: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Other outcomes:
measure: Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab
timeFrame: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
measure: Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose
timeFrame: 1, 2688 hours postdose on Day 1
measure: Total Clearance of Tanezumab From Plasma
timeFrame: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
measure: Terminal Elimination Half-Life (t1/2) of Tanezumab
timeFrame: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
measure: Volume of Distribution at Steady State (Vss) for Tanezumab
timeFrame: Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Locations:
city: Anniston
country: United States
facility: Anniston Medical Clinic/Pinnacle Research Group LLC
state: Alabama
city: Anniston
country: United States
facility: Anniston Neurology & Headache Mgmt. Ctr.
state: Alabama
city: Litchfield Park
country: United States
facility: Dedicated Clinical Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Atlantis
country: United States
facility: Jem Research, LLC
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Medical Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center, Advanced Research Consultants, Inc.
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinic
state: Kansas
city: Towson
country: United States
facility: International Research Center
state: Maryland
city: North Dartmouth
country: United States
facility: Infinity Medical Research, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Edina
country: United States
facility: Medical Advanced Pain Specialists (MAPS)
state: Minnesota
city: Saint Louis
country: United States
facility: A & A Pain Institute
state: Missouri
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Bryan
country: United States
facility: DiscoveResearch Incorporated
state: Texas
city: Dallas
country: United States
facility: Neurological Clinic of Texas
state: Texas
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Jay Ellis Jr., MD-Tejas Anesthesia
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Incorporated
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.