A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Neuralgia; Spinal Cord Injuries
• Intervention / Treatment: Drug: placebo; Drug: pregabalin

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • V Region
    • Vina del Mar, V Region, Chile, 2520024
      • Pfizer Investigational Site
• China
  • Beijing, China, 100068
    • Pfizer Investigational Site
  • Beijing
    • Beijing, Beijing, China, 100053
      • Pfizer Investigational Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Pfizer Investigational Site
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Pfizer Investigational Site
• Czechia
  • Brno, Czechia, 66250
    • Pfizer Investigational Site
  • Liberec 1, Czechia, 46063
    • Pfizer Investigational Site
  • Praha 5, Czechia, 15006
    • Pfizer Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Pfizer Investigational Site
• India
  • New Delhi, India, 110 070
    • Pfizer Investigational Site
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500 003
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 034
      • Pfizer Investigational Site
    • Bangalore, Karnataka, India, 560 052
      • Pfizer Investigational Site
    • Mangalore, Karnataka, India, 575002
      • Pfizer Investigational Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226 018
      • Pfizer Investigational Site
• Japan
  • Chiba, Japan
    • Pfizer Investigational Site
  • Tokushima, Japan
    • Pfizer Investigational Site
  • Yamagata, Japan
    • Pfizer Investigational Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Pfizer Investigational Site
  • Akita
    • Daisen, Akita, Japan
      • Pfizer Investigational Site
  • Fukuoka
    • Iizuka, Fukuoka, Japan
      • Pfizer Investigational Site
  • Hiroshima
    • Fukuyama, Hiroshima, Japan
      • Pfizer Investigational Site
  • Hokkaido
    • Bibai, Hokkaido, Japan
      • Pfizer Investigational Site
    • Hakodate, Hokkaido, Japan
      • Pfizer Investigational Site
    • Sapporo, Hokkaido, Japan
      • Pfizer Investigational Site
  • Hyogo
    • Kobe, Hyogo, Japan
      • Pfizer Investigational Site
  • Ibaraki
    • Sasima-gun, Ibaraki, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Pfizer Investigational Site
  • Kumamoto
    • Kikuchi-gun, Kumamoto, Japan
      • Pfizer Investigational Site
  • Miyagi
    • Sendai, Miyagi, Japan
      • Pfizer Investigational Site
  • Niigata
    • Kashiwazaki, Niigata, Japan
      • Pfizer Investigational Site
  • Oita
    • Beppu, Oita, Japan
      • Pfizer Investigational Site
  • Saitama
    • Hanyu, Saitama, Japan
      • Pfizer Investigational Site
    • Kitamoto, Saitama, Japan
      • Pfizer Investigational Site
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
      • Pfizer Investigational Site
  • Tochigi
    • Kanuma, Tochigi, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Kotoku, Tokyo, Japan
      • Pfizer Investigational Site
    • Musashimurayama-shi, Tokyo, Japan
      • Pfizer Investigational Site
  • Yamagata
    • Higashiokitama-gun, Yamagata, Japan
      • Pfizer Investigational Site
• Philippines
  • Cebu City, Philippines
    • Pfizer Investigational Site
  • Manila, Philippines
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1100
    • Pfizer Investigational Site
  • Manila
    • Espana, Manila, Philippines, 1008
      • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 105203
    • Pfizer Investigational Site
  • St.Petersburg, Russian Federation, 197706
    • Pfizer Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85050
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85027
      • Pfizer Investigational Site
  • California
    • Fresno, California, United States, 93710
      • Pfizer Investigational Site
    • Napa, California, United States, 94558
      • Pfizer Investigational Site
    • Northridge, California, United States, 91324
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91105
      • Pfizer Investigational Site
  • Florida
    • Miami, Florida, United States, 33136
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33125
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Pfizer Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Pfizer Investigational Site
    • White Plains, New York, United States, 10605
      • Pfizer Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Pfizer Investigational Site
  • Pennsylvania
    • Johnstown, Pennsylvania, United States, 15904
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Pfizer Investigational Site
    • Charleston, West Virginia, United States, 25301
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: matched placebo	Drug: placebo; Placebo
EXPERIMENTAL: pregabalin; flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period	Drug: pregabalin; Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day); Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration Adjusted Average Change (DAAC) of Mean Pain Score	DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weekly Mean Pain Score	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).	Baseline, Week 16
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).	Baseline, Week 16
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.	Baseline, Week 16
Change From Baseline in Weekly Mean Sleep Interference Score	Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).	Baseline, Week 16
Change From Baseline in Weekly Mean Pain Score by Week	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).	Baseline, Week 1 through16
Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).	Baseline, Week 16
Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score	The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia	Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia	Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia	Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli	Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia	Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales	Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score	Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.	Baseline, Week 16
Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)	NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.	Baseline, Week 16
Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)	NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)	Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.	Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 16
Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weekly Mean Sleep Interference Score by Week	Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).	Baseline, Week 1 through 16

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: December 1, 2006
• First Submitted That Met QC Criteria: December 4, 2006
• First Posted (ESTIMATE): December 5, 2006

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Pain; central neuropathic pain
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081107