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RN624 For Pain Of Post-Herpetic Neuralgia

Primary Purpose

Neuralgia, Postherpetic

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RN624

Placebo

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic focused on measuring monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Anniston Medical Clinic/Pinnacle Research Group LLC
Anniston Neurology & Headache Mgmt. Ctr.
Dedicated Clinical Research, Inc.
Arizona Research Center
Jem Research, LLC
Clinical Research of West Florida
Innovative Research of West Florida, Inc.
Miami Medical Associates
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Neurology Clinical Research, Inc.
Meridien Research
Cotton-O'Neil Clinical Research
Cotton-O'Neil Clinic
International Research Center
Infinity Medical Research, Inc.
Michigan Head Pain and Neurological Institute
Medical Advanced Pain Specialists (MAPS)
A & A Pain Institute
Asheville Neurology Specialists, PA
Rapid Medical Research, Inc.
Hometown Urgent Care and Research
Wells Institute for Health Awareness
Allegheny Pain Management, PC
Altoona Center for Clinical Research
DiscoveResearch Incorporated
Neurological Clinic of Texas
Mobley Research Center
Clinical Trials of Texas, Inc.
Jay Ellis Jr., MD-Tejas Anesthesia
Radiant Research San Antonio Northeast
National Clinical Research, Incorporated

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.

Secondary Outcome Measures

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.

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

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value.

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

mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score.

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

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported.

Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.

Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.

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

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.

Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score

Time to achieve >=30% or >=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain.

Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants

Total duration of response was defined as total number of days with a reduction of >=30% or >=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of >=30% or >=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported.

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

mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported.

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

Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented.

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported.

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

mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported.

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Time to Discontinuation Due to Lack of Efficacy

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.

Number of Participants Who Used Rescue Medications

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized.

Duration of Rescue Medication Use

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized.

Amount of Rescue Medication Taken

In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Abnormal Physical Examinations Findings at Screening

Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion.

Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16

Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.

Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16

Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation).

Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (<) 40 beats per minute and greater than (>) 150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute.

Number of Participants With Laboratory Abnormalities

Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium <0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).

Number of Participants With Electrocardiogram (ECG) Abnormalities

Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.

Number of Participants With Positive Anti-Drug Antibody (ADA) Response

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for PF-04383119 were considered as ADA positive.

Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study

HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall.

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Full Information

NCT ID

NCT00568321

First Posted

December 3, 2007

Last Updated

May 5, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00568321

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

December 19, 2007 (Actual)

Primary Completion Date

December 20, 2008 (Actual)

Study Completion Date

January 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia, Postherpetic

Keywords

monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

RN624

Intervention Description

50 mcg/kg

Intervention Type

Drug

Intervention Name(s)

RN624

Intervention Description

200 mcg/kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6

Description

Time Frame

Baseline, Week 6

Secondary Outcome Measure Information:

Title

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16

Description

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.

Time Frame

Baseline, Week 1, 2, 4, 8, 12, 16

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16

Title

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

Description

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported.

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6

Description

Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.

Time Frame

Baseline, Week 6

Title

Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6

Description

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.

Time Frame

Baseline, Week 6

Title

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

Description

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12, 16

Title

Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score

Description

Time Frame

Baseline up to Week 16

Title

Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants

Description

Time Frame

Baseline to Week 16

Title

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

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12 and 16

Title

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

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8 ,12, 16

Title

Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

Description

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

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

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12, 16

Title

Number of Participants Who Discontinued the Study Due to Lack of Efficacy

Time Frame

Baseline up to Week 16

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants Who Used Rescue Medications

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Title

Duration of Rescue Medication Use

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Title

Amount of Rescue Medication Taken

Description

Time Frame

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to 112 days after the last dose of study drug (up to Week 16)

Title

Number of Participants With Abnormal Physical Examinations Findings at Screening

Description

Time Frame

Screening visit (1 day prior to Day 1 baseline visit)

Title

Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16

Description

Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.

Time Frame

Baseline, Week 16

Title

Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16

Description

Time Frame

Baseline, Week 16

Title

Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16

Description

Time Frame

Baseline, Week 16

Title

Number of Participants With Laboratory Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Electrocardiogram (ECG) Abnormalities

Description

Time Frame

Baseline up to Week 16

Title

Number of Participants With Positive Anti-Drug Antibody (ADA) Response

Description

Time Frame

Baseline up to Week 16

Title

Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study

Description

Time Frame

Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)

Title

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab

Description

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Time Frame

Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Other Pre-specified Outcome Measures:

Title

Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab

Description

Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).

Time Frame

Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Title

Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose

Description

Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported.

Time Frame

1, 2688 hours postdose on Day 1

Title

Total Clearance of Tanezumab From Plasma

Description

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Time Frame

Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Title

Terminal Elimination Half-Life (t1/2) of Tanezumab

Description

Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration.

Time Frame

Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Title

Volume of Distribution at Steady State (Vss) for Tanezumab

Description

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Time Frame

Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Anniston Medical Clinic/Pinnacle Research Group LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Anniston Neurology & Headache Mgmt. Ctr.

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Dedicated Clinical Research, Inc.

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Jem Research, LLC

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Clinical Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Innovative Research of West Florida, Inc.

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

Miami Medical Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33418

Country

United States

Facility Name

Neurology Clinical Research, Inc.

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Meridien Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Cotton-O'Neil Clinical Research

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Cotton-O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

International Research Center

City

Towson

State/Province

Maryland

ZIP/Postal Code

21286

Country

United States

Facility Name

Infinity Medical Research, Inc.

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Michigan Head Pain and Neurological Institute

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Medical Advanced Pain Specialists (MAPS)

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

A & A Pain Institute

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Asheville Neurology Specialists, PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Rapid Medical Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Hometown Urgent Care and Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Wells Institute for Health Awareness

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Allegheny Pain Management, PC

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635-0909

Country

United States

Facility Name

DiscoveResearch Incorporated

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

Neurological Clinic of Texas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Mobley Research Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Clinical Trials of Texas, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Jay Ellis Jr., MD-Tejas Anesthesia

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Radiant Research San Antonio Northeast

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

National Clinical Research, Incorporated

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

25594611

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091005&StudyName=RN624%20For%20Pain%20Of%20Post-Herpetic%20Neuralgia

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

RN624 For Pain Of Post-Herpetic Neuralgia

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