An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

NCT01202227 | Completed Phase 3 Results

• 1 other identifier: A0081252
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Neuralgia; Pain

Keywords

Central Nervous System Diseases; Therapeutic Uses; Wounds and Injuries; Trauma; Nervous System; pregabalin

Outcome Measures

Primary Outcomes (12)

• Number of Participants With Peripheral Edema

  Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Facial/Periorbital Edema

  Number of participants who had facial or periorbital edema.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Generalized or Abdominal Edema

  Number of participants who had generalized or abdominal edema.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)

  DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Visual Field Deteriorated

  Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).

  53 weeks

• Number of Participants With Deterioration in Neurological Examination Findings

  Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.

  53 weeks

• Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)

  The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.

  Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

Secondary Outcomes (4)

• Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores

  Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

• Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores

  Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

• Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores

  Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

• Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score

  Baseline, Week 52

Study Arms (1)

Pregabalin

EXPERIMENTAL

Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period

Drug: pregabalin

Interventions

pregabalin DRUG

Pregabalin capsules taken twice a daily (150-600mg/day)

Pregabalin

Eligibility Criteria

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

You may qualify if:

• Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
• Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
• Subjects with central neuropathic pain after stroke or multiple sclerosis;
• At least 6 months have passed after the onset of central neuropathic pain;
• Pain VAS at least 40mm in Visit 1 and Visit 2;

You may not qualify if:

• Creatinine clearance \< 60 mL/min;
• Platelet count \< 100 × 103/mm3 ; White blood cell (WBC) count \< 2500 / mm3; Neutrophil count \< 1500/ mm3;
• Subjects who are expected to require surgery during the trial;

Sponsors & Collaborators

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

Study Sites (26)

Chubu Rosai Hospital

Nagoya, Aichi-ken, Japan

Location

Kimura Clinic

Nagoya, Aichi-ken, Japan

Location

Nagoya Kyoritsu Clinic

Nagoya, Aichi-ken, Japan

Location

Senboku Kumiai General Hospital

Daisen, Akita, Japan

Location

Go neurosurgical clinic

Chikushi-gun, Fukuoka, Japan

Location

Spinal Injuries Center

Iizuka, Fukuoka, Japan

Location

Brain Attack Center Ota Memorial Hospital

Fukuyama, Hiroshima, Japan

Location

Hokkaido Chuo Rosai Hospital Sekison Center

Bibai, Hokkaido, Japan

Location

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Location

Kobe Tokushukai Hospital

Kobe, Hyōgo, Japan

Location

Aida Kinen Rehabilitation Hospital

Moriya, Ibaraki, Japan

Location

General Hanamaki Hospital

Hanamaki, Iwate, Japan

Location

Uchida Rehabilitation Orthopedic Clinic

Kawasaki, Kanagawa, Japan

Location

Kumamoto Rehabilitation Hospital

Kikuchi-gun, Kumamoto, Japan

Location

Kohnan Hospital

Sendai, Miyagi, Japan

Location

Sendai Pain Clinic

Sendai, Miyagi, Japan

Location

National Hospital Organization Niigata National Hospital

Kashiwazaki, Niigata, Japan

Location

Nakamura Hospital

Beppu, Oita Prefecture, Japan

Location

Kitasato University Kitasato Institute Medical Center Hospital

Kitamoto, Saitama, Japan

Location

Kamitsuga General Hospital

Kanuma, Tochigi, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

Jukoukai hospital

Koto-ku, Tokyo, Japan

Location

National Hospital Organization, Murayama Medical Center

Musashimurayama-shi, Tokyo, Japan

Location

Okitama Public General Hospital

Higashiokitama-gun, Yamagata, Japan

Location

Tokushima University Hospital

Tokushima, Japan

Location

National Hospital Organization Yamagata Hospital

Yamagata, Japan

Location

Related Publications (1)

• Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.

  PMID: 25114584 DERIVED

Related Links

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

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Neuralgia; Pain; Central Nervous System Diseases; Wounds and Injuries; Neurologic Manifestations

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Trauma, Nervous System; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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.gov_Inquiries@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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 15, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: May 17, 2013

Record last verified: 2013-04

Locations

JP (26)