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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00407745
First received: December 1, 2006
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Neuralgia
Spinal Cord Injuries
Drug: placebo
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Duration Adjusted Average Change (DAAC) of Mean Pain Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Weekly Mean Pain Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Weekly Mean Sleep Interference Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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]).

  • Change From Baseline in Weekly Mean Pain Score by Week [ Time Frame: Baseline, Week 1 through16 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 220
Study Start Date: January 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lyrica

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407745

  Show 67 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00407745     History of Changes
Other Study ID Numbers: A0081107
Study First Received: December 1, 2006
Results First Received: November 3, 2011
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pain
central neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 28, 2014