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

NCT00407745 | Completed Phase 3 Results DMC

• 1 other identifier: A0081107
• Study Type: interventional
• Target: 220
• Locations: 10 countries
• Sites: 67

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.

Conditions

Neuralgia; Spinal Cord Injuries

Keywords

Pain; central neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Change From Baseline in Weekly Mean Pain Score

  Baseline, Week 16

• Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline

  Baseline, Week 16

• Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)

  Baseline, Week 16

• Change From Baseline in Weekly Mean Sleep Interference Score

  Baseline, Week 16

• Change From Baseline in Weekly Mean Pain Score by Week

  Baseline, Week 1 through16

Other Outcomes (1)

• Change From Baseline in Weekly Mean Sleep Interference Score by Week

  Baseline, Week 1 through 16

Study Arms (2)

matched placebo

PLACEBO COMPARATOR

Drug: placebo

pregabalin

EXPERIMENTAL

flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period

Drug: pregabalin

Interventions

placebo DRUG

Placebo

matched placebo

pregabalin DRUG

Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)

Also known as: Lyrica

pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (67)

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

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Pfizer Investigational Site

Phoenix, Arizona, 85027, United States

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Phoenix, Arizona, 85050, United States

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Fresno, California, 93710, United States

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Napa, California, 94558, United States

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Northridge, California, 91324, United States

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Pasadena, California, 91105, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32806, United States

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Indianapolis, Indiana, 46250, United States

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Overland Park, Kansas, 66211, United States

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Detroit, Michigan, 48201, United States

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New York, New York, 10029, United States

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White Plains, New York, 10605, United States

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Winston-Salem, North Carolina, 27103, United States

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Bellevue, Ohio, 44811, United States

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Johnstown, Pennsylvania, 15904, United States

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Philadelphia, Pennsylvania, 19107, United States

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Dallas, Texas, 75246, United States

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Charleston, West Virginia, 25301, United States

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Charleston, West Virginia, 25304, United States

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Viña del Mar, Región de Valparaíso, 2520024, Chile

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Beijing, Beijing Municipality, 100053, China

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Chengdu, Sichuan, 610041, China

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Beijing, 100068, China

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Medellín, Antioquia, Colombia

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Brno, 66250, Czechia

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Liberec, 46063, Czechia

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Prague, 15006, Czechia

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Hong Kong, 0, Hong Kong

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Secunderabad, Andhra Pradesh, 500 003, India

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Bangalore, Karnataka, 560 034, India

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Bangalore, Karnataka, 560 052, India

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Mangalore, Karnataka, 575002, India

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Lucknow, Uttar Pradesh, 226 018, India

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New Delhi, 110 070, India

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Nagoya, Aichi-ken, Japan

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Daisen, Akita, Japan

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Iizuka, Fukuoka, Japan

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Fukuyama, Hiroshima, Japan

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Bibai, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Sasima-gun, Ibaraki, Japan

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Kawasaki, Kanagawa, Japan

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Kikuchi-gun, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Kashiwazaki, Niigata, Japan

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Beppu, Oita Prefecture, Japan

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Hanyū, Saitama, Japan

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Kitamoto, Saitama, Japan

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Hamamatsu, Shizuoka, Japan

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Kanuma, Tochigi, Japan

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Kotoku, Tokyo, Japan

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Musashimurayama-shi, Tokyo, Japan

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Pfizer Investigational Site

Higashiokitama-gun, Yamagata, Japan

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Chiba, Japan

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Tokushima, Japan

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Pfizer Investigational Site

Yamagata, Japan

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Pfizer Investigational Site

España, Manila, 1008, Philippines

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Pfizer Investigational Site

Cebu City, Philippines

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Pfizer Investigational Site

Manila, Philippines

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Pfizer Investigational Site

Quezon City, 1100, Philippines

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Pfizer Investigational Site

Moscow, 105203, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 197706, Russia

Location

Related Publications (3)

• 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.

  PMID: 28072797 DERIVED

• 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.

  PMID: 27611736 DERIVED

• 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.

  PMID: 23345639 DERIVED

Related Links

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

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: January 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 25, 2021
• Results First Posted: December 8, 2011

Record last verified: 2012-02

Locations

IN (6); CO (1); RU (2); CL (1); HK (1); US (22); CZ (3); CN (3); PH (4); JP (24)