Clinical trial NCT00407745: A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Official title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuralgia
Spinal Cord Injuries
Keywords: Pain
central neuropathic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 220
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: The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.


Eligibility criteria: Inclusion Criteria:

* Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
* Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
* Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

* Pregabalin use in the last 60 days, prior intolerance to pregabalin
* Creatinine clearance \<60 mL/min.
* White blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3.
* Abuse of drugs or alcohol
* Unstable medial conditions
* Clinically significant abnormal electrocardiogram (ECG).
* Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.

Primary outcomes:
measure: Duration Adjusted Average Change (DAAC) of Mean Pain Score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Weekly Mean Pain Score
timeFrame: Baseline, Week 16
measure: Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
timeFrame: Baseline, Week 16
measure: Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Weekly Mean Sleep Interference Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Weekly Mean Pain Score by Week
timeFrame: Baseline, Week 1 through16
measure: Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score
timeFrame: Baseline, Week 16
measure: Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
timeFrame: Baseline, Week 16
measure: Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
timeFrame: Baseline, Week 16
measure: Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
timeFrame: Baseline, Week 16
measure: Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
timeFrame: Baseline, Week 16
measure: Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
timeFrame: Baseline, Week 16
Other outcomes:
measure: Change From Baseline in Weekly Mean Sleep Interference Score by Week
timeFrame: Baseline, Week 1 through 16
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Napa
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: White Plains
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Vina del Mar
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Medellín
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Liberec 1
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Secunderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Daisen
country: Japan
facility: Pfizer Investigational Site
state: Akita
city: Iizuka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Fukuyama
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Bibai
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Hakodate
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Sasima-gun
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Kawasaki
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Kikuchi-gun
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Kashiwazaki
country: Japan
facility: Pfizer Investigational Site
state: Niigata
city: Beppu
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Hanyu
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kitamoto
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Kanuma
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Kotoku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashimurayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Higashiokitama-gun
country: Japan
facility: Pfizer Investigational Site
state: Yamagata
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Tokushima
country: Japan
facility: Pfizer Investigational Site
city: Yamagata
country: Japan
facility: Pfizer Investigational Site
city: Espana
country: Philippines
facility: Pfizer Investigational Site
state: Manila
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St.Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
citation: Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
citation: Cardenas DD, Nieshoff EC, Suda K, Goto S, Sanin L, Kaneko T, Sporn J, Parsons B, Soulsby M, Yang R, Whalen E, Scavone JM, Suzuki MM, Knapp LE. A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. Neurology. 2013 Feb 5;80(6):533-9. doi: 10.1212/WNL.0b013e318281546b. Epub 2013 Jan 23.