Clinical trial NCT01202227: An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Official title: An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Diseases
Spinal Cord Injuries
Neuralgia
Pain
Keywords: Central Nervous System Diseases
Therapeutic Uses
Wounds and Injuries
Trauma
Nervous System
pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for subjects to be shifted from Study A0081107

* 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);

Inclusion criteria for subjects to be new participants in this study

* 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;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Number of Participants With Peripheral Edema
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Facial/Periorbital Edema
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Generalized or Abdominal Edema
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
timeFrame: Baseline, Weeks 4, 20, 36, 52, and 53
measure: Number of Participants With Visual Field Deteriorated
timeFrame: 53 weeks
measure: Number of Participants With Deterioration in Neurological Examination Findings
timeFrame: 53 weeks
measure: Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary outcomes:
measure: Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
timeFrame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
measure: Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
timeFrame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
measure: Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
timeFrame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
measure: Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Kimura Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Kyoritsu Clinic
state: Aichi
city: Daisen
country: Japan
facility: Senboku Kumiai General Hospital
state: Akita
city: Chikushi-gun
country: Japan
facility: Go neurosurgical clinic
state: Fukuoka
city: Iizuka
country: Japan
facility: Spinal Injuries Center
state: Fukuoka
city: Fukuyama
country: Japan
facility: Brain Attack Center Ota Memorial Hospital
state: Hiroshima
city: Bibai
country: Japan
facility: Hokkaido Chuo Rosai Hospital Sekison Center
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe Tokushukai Hospital
state: Hyogo
city: Moriya
country: Japan
facility: Aida Kinen Rehabilitation Hospital
state: Ibaraki
city: Hanamaki
country: Japan
facility: General Hanamaki Hospital
state: Iwate
city: Kawasaki
country: Japan
facility: Uchida Rehabilitation Orthopedic Clinic
state: Kanagawa
city: Kikuchi-gun
country: Japan
facility: Kumamoto Rehabilitation Hospital
state: Kumamoto
city: Sendai-city
country: Japan
facility: Sendai Pain Clinic
state: Miyagi
city: Sendai
country: Japan
facility: Kohnan Hospital
state: Miyagi
city: Kashiwazaki
country: Japan
facility: National Hospital Organization Niigata National Hospital
state: Niigata
city: Beppu
country: Japan
facility: Nakamura Hospital
state: Oita
city: Kitamoto
country: Japan
facility: Kitasato University Kitasato Institute Medical Center Hospital
state: Saitama
city: Kanuma
country: Japan
facility: Kamitsuga General Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Jukoukai hospital
state: Tokyo
city: Musashimurayama-shi
country: Japan
facility: National Hospital Organization, Murayama Medical Center
state: Tokyo
city: Higashiokitama-gun
country: Japan
facility: Okitama Public General Hospital
state: Yamagata
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Yamagata
country: Japan
facility: National Hospital Organization Yamagata Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.