Clinical trial NCT01087203: A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
Official title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Keywords: diabetic peripheral neuropathy
tanezumab
diabetic neuropathies
diabetic polyneuropathy
diabetic neuropathy painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.

Detailed description: This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.
* Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.
* Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
* A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.
* Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.

Exclusion Criteria:

* Painful neuropathies other than diabetic peripheral neuropathy.
* Other types of diabetic neuropathies.
* Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.
* Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.
* Patients with a present (current) history of sciatica are not eligible for participation.
* The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.
* Amputations dues to diabetes.
* Patient with any clinically significant medical condition or laboratory abnormalities.
* History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
* History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).
* History of known alcohol, analgesic or drug abuse within 2 years of Screening.
* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.

Primary outcomes:
measure: Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12
measure: Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
timeFrame: Week 16
measure: Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 8, 16
measure: Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16
timeFrame: Baseline, Week 8, 16
measure: Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16
timeFrame: Baseline, Week 4, 8, 12, 16
measure: Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy
timeFrame: Week 4, 8, 12, 16
measure: Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16
timeFrame: Baseline, Week 16
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Number of Participants Who Used Rescue Medication
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Days Per Week of Rescue Medication Usage
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Amount of Rescue Medication Taken
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after last dose of study treatment (up to 169 days)
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Change From Baseline Physical Examination
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 24
measure: Number of Participants With Anti Drug Antibody (ADA) for Tanezumab
timeFrame: Baseline, Week 8, 16, 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16 and 24
measure: Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Sensory Testing (QST) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF
timeFrame: Baseline, Week 16
measure: Plasma Tanezumab Concentration
timeFrame: Baseline(Day 1), Week 2, 4, 8, 12, 16, 24
measure: Serum Nerve Growth Factor (NGF)
timeFrame: Day 1, Week 8, 16, 24
Other outcomes:
measure: Number of Participants With Subcutaneous Doses of Study Medication
timeFrame: Day 1 up to Week 8
Locations:
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinic
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Goodyear
country: United States
facility: Valley Radiology, Ltd.
state: Arizona
city: Litchfield Park
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Anaheim Hills
country: United States
facility: Anaheim Hills MRI Holdings, Inc
state: California
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Irvine
country: United States
facility: NervePro Medical Corporation
state: California
city: Irvine
country: United States
facility: United Medical Imaging Healthcare (X-Ray Only)
state: California
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: La Jolla
country: United States
facility: LabCorp (Draw blood only)
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc
state: Colorado
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Fort Walton Beach
country: United States
facility: White Wilson Medical Center
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J. Mate, MD
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: Decatur
country: United States
facility: Neurology Specialists of Decatur Research Center
state: Georgia
city: Decatur
country: United States
facility: Neurology Specialists of Decatur
state: Georgia
city: Fort Wayne
country: United States
facility: Allied Physicians Inc d/b/a Fort Wayne Neurology
state: Indiana
city: Greenfield
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Greenfield
country: United States
facility: Radiology Department, American Health Network
state: Indiana
city: Lenexa
country: United States
facility: Lee Research Institute
state: Kansas
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Centers
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Nixa
country: United States
facility: Ozarks Community Hospital Christian County Clinic
state: Missouri
city: Springfield
country: United States
facility: Clinvest/A Division of Banyan Group, Inc.
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute Foundation
state: Montana
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Dayton
country: United States
facility: Joel Vandersluis, MD
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Toledo
country: United States
facility: Neurology and Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mark A. Fisher M.D. -Private Practice
state: Oklahoma
city: Greensburg
country: United States
facility: Westmoreland Neurology Associates, Inc
state: Pennsylvania
city: Orangeburg
country: United States
facility: The Neurology and Pain Clinic
state: South Carolina
city: Houston
country: United States
facility: Centex Research/Pineloch Medical Center
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Daniel B. Vine, MD
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: West Jordan
country: United States
facility: RGL Medical Services
state: Utah
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.