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Safety Escalating Repeat IV, in Stroke Patients (MAG111539)

2017年10月17日 更新者：GlaxoSmithKline

A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Repeat Doses of GSK249320 in Patients With Stroke

The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to placebo in patients with stroke.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to myelin-associated glycoprotein (MAG) and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity. The present study is the first in patients with stroke. The main aim of this study is to select tolerated doses of GSK249320 that can be used in future trials to evaluate its efficacy in improving clinical function in patients recovering from stroke. This clinical trial is designed as a placebo-controlled, single-blind, multicenter study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating repeat IV doses of GSK249320. Three sequential dose escalation cohorts (1, 5 and 15 mg/kg) are planned, with 8 patients on placebo and 8 on active in cohort 1 and 4 patients on placebo and 8 on active in cohorts 2 and 3. Each patient will receive 2 repeat IV doses 9 ± 1 days apart and assessments will extend to at least 16 weeks.

研究の種類

介入

入学 (実際)

42

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095-6984
        • GSK Investigational Site
      • Orange、California、アメリカ、92868-4280
        • GSK Investigational Site
    • Colorado
      • Fort Collins、Colorado、アメリカ、80524
        • GSK Investigational Site
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • GSK Investigational Site
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • GSK Investigational Site
  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M4N 3M5
        • GSK Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1E2
        • GSK Investigational Site
  • ドイツ
    • Baden-Wuerttemberg
      • Ulm、Baden-Wuerttemberg、ドイツ、89081
        • GSK Investigational Site
    • Hessen
      • Wiesbaden、Hessen、ドイツ、65199
        • GSK Investigational Site
    • Niedersachsen
      • Celle、Niedersachsen、ドイツ、29223
        • GSK Investigational Site
      • Hannover、Niedersachsen、ドイツ、30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen、Nordrhein-Westfalen、ドイツ、45122
        • GSK Investigational Site
      • Koeln、Nordrhein-Westfalen、ドイツ、50937
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz、Rheinland-Pfalz、ドイツ、55131
        • GSK Investigational Site
    • Sachsen
      • Leipzig、Sachsen、ドイツ、04103
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～90年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Have a confirmed diagnosis of stroke
  • Stroke onset must be within the last 24-72 hours.
  • Have a stroke that is either:
  • radiologically confirmed to be ischaemic and supratentorial. The diameter of the ischemic lesion is >15mm in any singlle direction or the volume is >4cc. OR
  • radiologically confirmed to be an intracerebral hemorrhage that is supratentorial, deep (i.e., blood must not directly contact cerebral cortex) and with minimal or no intraventricular extension. The Intracerebral Hemorrahage (CH) score must be 0-2 and is calculated based on age, Galsgow coma Scale score ad the initial CT or MRI findings for the index stroke. See the SOM for the full calculation procedure.
  • Have a total NIHSS score of 3-21.
  • Have an upper and/or lower limb deficit defined as:
  • Score of 1-3 on the NIHSS Motor Arm question, and palpable and observable voluntary extension or flexion of the fingers. AND/OR b. Score of 1-3 on the NIHSS Motor Leg question
  • Aged 18-90, inclusive.
  • Male subjects and females of non-child-bearing potential are allowed to participate in this study.
  • Females of child-bearing potential are also allowed to participate in this study provided they are using a contraceptive method with a failure rate of <1%.

Exclusion Criteria:

  • History of a previous symptomatic stroke within 3 months prior to study entry.
  • Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of >2.
  • Presence of depression that is active and not adequately controlled such that it interferred with major activities of daily living immediately prior to the current stroke.
  • Subjects who are not alert or are unresponsive as defined by a score of 2 or 3 on the NIHSS Level of Consciousness question (question #1a).
  • Presence of significant aphasia as likely to confound or interfere with completion of the study assessments.
  • Presence of peripheral neuropathy, including diabetic neuropathy, which is clinically active and symptomatic at time of screening.
  • Presence of neurological or psychiatric disease, such as dementia or mild cognitive impairment, prior to study entry that is likely to confound clinical evaluations.
  • Presence of a demyelinating disease, such as multiple sclerosis.
  • Evidence of other chronic co-morbid conditions or unstable acute systemic illnesses which, in the opinion of the investigator, could shorten the subject's survival or limit his/her ability to complete the study.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Presence of QTcB > 500 msec; or uncorrected QT >600msec (machine or manual over-read) on baseline ECG.
  • Contraindication to TMS, such as:
  • have metal present, such as hardware or plate on the scalp in the area to which TMS will be applied, implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials
  • occupation or activity that may cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects can be cleared by a head computed tomography scan.
  • concomitant use of drugs that substantially lower seizure threshold (e.g., tricyclic antidepressants and neuroleptics)
  • known history of seizures or epilepsy
  • brain tumor, recent brain injury (within 5 years) associated with definite loss of consciousness, or any history of brain surgery
  • Contraindication to MRI, such as:
  • have metal present, such as implanted cardiac pacemaker, implanted prosthetic heart valve, medication pump or line, metallic implant or clip in the head/neck, electrical, mechanical or magnetic implants, neuro-stimulation device, or orthodontic work involving ferromagnetic materials, permanent tattooed metallic eye-liner
  • occupation or activity that may cause accidental lodging of ferromagnetic materials or embedded metal fragments in the head. Subjects can be cleared by a head computed tomography scan.
  • claustrophobia
  • Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Pregnant or lactating females.

  • Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：プラセボ
プラセボ
実験的：アクティブ
薬：GSK249320
I.V. infusion

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
時間枠：Up to 112 days
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Up to 112 days
Number of Participants With Vital Signs Changes of Potential Clinical Importance
時間枠：Up to 112 days
The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (SBP) (<85 and >200 millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (<45 and >110 mmHg) and heart rate (HR) (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Up to 112 days
Number of Participants With Electrocardiogram (ECG) Values Outside Range of Potential Clinical Importance
時間枠：Up to 112 days
Single 12-lead ECGs was obtained. The standard ECG criteria of potential clinical importance were uncorrected QT interval <300 and >600 milliseconds (msec), absolute QTc interval >500 msec, increase from Baseline QTc >60 msec, RR Interval <90 and >2000 msec, PR Interval <110 and >220 msec, QRS Interval <75 and >110 msec. The number of participants with potentially clinically significant ECG abnormality were reported.
Up to 112 days
Number of Participants With Nerve Conduction Testing (NCT) Values
時間枠：Day 5 and 30 and at early withdrawal
NCT (electrode placement technique) of sensory and motor function was performed on the unaffected side (i.e., side that is not affected by the stroke) by appropriately qualified personnel at specified visits (Day 5 and 30 and at early withdrawal). Qualified technician performed the testing; however the same neurologist interpreted the NCT data within a single participant. Both upper and lower extremity nerves were tested and the data was recorded. Number of participants with normal and abnormal NCT data were reported.
Day 5 and 30 and at early withdrawal
Number of Participants With White Matter Changes and Demyelination Assessed by Magnetic Resonance Imaging (MRI)
時間枠：Up to Day 60
Whole brain MRI scans were performed by appropriately qualified personnel at those specified visits (Day 1, 10 and 60 or at early withdrawal [if participant withdrew from study before Day 60 MRI]). Required pulse sequences of diffusion weighted imaging (DWI), T1, and T2 FLAIR was performed to measure lesion volume and to look for the presence of any new acute inflammatory lesions. The investigator or other medically qualified study team member evaluated the Day 10 and 60 scans for any new abnormalities or clinically significant worsening. Digital data for each MRI was sent to a central MRI laboratory for an over-read of the MRI scan and calculation of the lesion volume. Number of participants with change in white matter and demyelination on Day 10 compared to Day 1, Day 60 compared to Day 1 and Day 60 compared to Day 10 were reported.
Up to Day 60
Number of Participants With Abnormal Clinical Chemistry Parameters
時間枠：Up to Day 112
The clinical chemistry parameters analyzed were albumin, calcium, creatinine, glucose, potassium, sodium, total CO2, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal clinical chemistry findings at specified visit were reported.
Up to Day 112
Number of Participants With Abnormal Hematological Parameters
時間枠：Up to Day 112
The clinical chemistry parameters analyzed were white blood cell count, neutrophil count, hemoglobin, platelet count, lymphocytes. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal hematology findings at specified visit were reported.
Up to Day 112

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Positive Antibodies to GSK249320
時間枠：Day 1, 5, 10, 30, 60, 90 and 112
Presence of antibodies to GSK249320 were assessed in serum samples of participants using immunoelectro-chemiluminescent assay. Number of participants with positive antibodies to GSK249320 were reported. Only visits where the true positive antibody detection was observed were reported.
Day 1, 5, 10, 30, 60, 90 and 112
Mean Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC 0-inf) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t)
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. AUC0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC(0-inf) were calculated, where data permit, as the sum of area under the concentration-time curve over the dosing interval from 0 to Day 10 ±1 day (AUC0-10d) and C10d/z, where C10d is the observed plasma concentration at day 10 and z is the terminal phase rate constant calculated after the second dose.
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Maximum Observed Concentration (Cmax) and Last Observed Quantifiable Concentration (Ct)
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non- compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Cmax and Ct were determined directly from the raw concentration-time data.
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Time of Occurrence of Cmax (Tmax) and Time of Last Observed Quantifiable Concentration (Tlast)
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Tmax and tlast were determined directly from the raw concentration-time data.
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Terminal Phase Half-life (t1/2)
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The apparent t1/2 obtained as the ratio of natural log (ln)^2/ lambda-Z, where lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Terminal Phase Rate Constant ( Lambda-Z)
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Clearance of GSK249320
時間枠：Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The clearance was calculated as Dose/ AUC(0-inf).
Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)
Mean Change in Mean Gait Velocity
時間枠：Baseline (Day 5), Day 30, 60, 90, 112
Gait velocity is an objective, quantitative, reliable, valid and sensitive measure of lower extremity motor recovery in the stroke population. Changes in gait velocity correlates with physical functioning and quality of life. Gait velocity was assessed over a level, indoor 10 meter distance. The time (in seconds) it takes the participant to travel the 10 meter distance was recorded. Participants was asked to walk at their usual or normal pace and may use their normal assistive devices. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 5), Day 30, 60, 90, 112
Mean Change in Berg Balance Scale (BBS) Total Score
時間枠：Baseline (Day 5), Day 30, 60, 90 and 112
BBS is a performance based measure of balance. It is reliable, valid and responsive to change in the stroke population. BBS is a staff-assessed measure that requires the participant to perform 14 activities that evaluate ability to maintain balance. The BBS typically takes 10-15minute to complete. Participants were not allowed to use assistive devices while performing the activities. Each activity was evaluated by direct observation of the participant's performance and was scored on a 5-point ordinal scale (0-4) where a score of 0 represents inability to perform the activity and a score of 4 represents independence in the activity. The minimum total score on the BBS was 0 and maximum was 56. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 5), Day 30, 60, 90 and 112
Mean Change in Total Fugl-Meyer Motor (FM) Assessment
時間枠：Baseline (Day 5), Day 30 and 112
The FM assessment is a staff-assessed, disease specific, quantitative measure of impairment that is used to assess recovery of sensorimotor function post stroke. The FM is designed to assess the domains of motor function, balance, sensation and joint function. For this study, only the motor function domain was assessed. The motor domain scale takes approximately 30 minutes to complete and evaluates both the upper and lower extremities by direct observation of the participant's performance of 50 items that measure movement, coordination, and reflex action. Each item was scored from 0-2 for a minimum total score of 0 (hemiplegia) and a maximum total score of 100 (normal motor performance). Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 5), Day 30 and 112
Mean Change in Total Box and Blocks Transferred on Affected Side
時間枠：Baseline (Day 1), Day 30, 60, 90 and 112
The Box and Blocks test is an objective, gross manual dexterity test that is reliable and valid in individuals with upper limb impairments. Box and Blocks was a staff-assessed, participant completed test that required the participant to move small wooden blocks from one side of a partitioned box to the other. The score was determined by the number of blocks transferred within a 60 second time period. More number of blocks transferred as compared to Baseline indicated improvement. Both the impaired and normal limbs were tested, starting with the normal limb. The number of blocks transferred were recorded. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 1), Day 30, 60, 90 and 112
Mean Change in Grip Strength on Affected Side
時間枠：Baseline (Day 1), Day 30, 60, 90 and 112
Grip strength is an objective measure of arm motor recovery in stroke participants and correlate with functional status and predict recovery. Grip strength was evaluated by a hand grip dynamometer. Three replicate trials was collected for both the impaired and normal hand, starting with the normal hand. Each trial was separated by a resting period of approximately 15-30 seconds. Participants was instructed to squeeze as hard as possible while using a standardized position of grip and the resulting dynamometer reading (in kg) was recorded. The grip strength measures was conducted within approximately 5 minutes. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 1), Day 30, 60, 90 and 112
Number of Participants With Modified Rankin Scale (mRS)
時間枠：Day 30 and 90
The mRS was a 6 point scale that measured participant handicap by evaluating limitations in activity and changes in lifestyle. The mRS was staff-assessed and scored from 0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderate severe disability, 5=severe disability (severe disability, bedridden, incontinent and requiring constant nursing care and attention). The structured interview was used to administer the mRS. The mRS took approximately 15 minutes to complete when using the structured interview. Number of participants with mRS were reported as per the category of the score.
Day 30 and 90
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS)
時間枠：Baseline (Day 1), Day 10, 30 and 90
The NIHSS is a staff-assessed, 15 item, standardized, disease-specific, deficit scale which measures neurological impairment and is used to quantify participant status by measuring the severity of the stroke. The total NIHSS score ranged from 0 (No impairment) to 42 (severe impairment). Approximately 15 minutes were needed to complete the NIHSS. The NIHSS will be collected as part of the eligibility requirements to exclude participants who have a deficit that is either too mild or too severe. Only NIHSS certified study personnel recorded the NIHSS. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 1), Day 10, 30 and 90
Mean Barthel Total Score
時間枠：Day 30 and 90
The Barthel was a staff-assessed, 10 item activities of daily living index that evaluated feeding, grooming, dressing, excretion (bowels, bladder and toilet skills), bathing, and mobility (transfers, walking, stairs). The total Barthel score ranged from either 0-20 or 0-100 depending on which scoring algorithm was used where 0= unable or dependent and 20 or 100= independent to perform daily activities. For this study, the 100 point scoring algorithm was used. The Barthel takes approximately 5-10 minutes to complete with the participant.
Day 30 and 90
Mean Total Montreal Cognitive Assessment (MoCA) Score
時間枠：Day 5 and 90
MoCA was an examiner-administered, screening instrument with good validity, reliability, sensitivity and specificity for mild cognitive dysfunction. The MoCA had been studied in stroke participants and was recommended as a tool to monitor and measure cognitive changes post stroke as part of the 2006 National Institute of Neurological Disorders and Stroke - Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards. The MoCA assesses eight cognitive domains of visuospatial skills, executive function, language, attention, concentration, working memory, memory, and orientation. Participants were asked to complete 14 activities which the examiner scored according to the standardized scoring instructions. While there was no set time limit imposed on a participant. The total MoCA score ranges from 0-30, where 0= worsening and 30 reflects normal cognitive function.
Day 5 and 90
Mean Geriatric Depression Scale (GDS)
時間枠：Day 5 and 90
The short form GDS is a measure of depression developed specifically for use in elderly population and is sensitive and valid in the stroke population. The GDS was a participant-completed, 15 item questionnaire where each question referenced how the participant felt over the past week. Each question was answered with either a 'yes' or 'no' response. Of the 15 questions, 10 of them indicate depression when answered 'yes' (questions 2-4, 6, 8-10, 12, 14-15) and 5 indicate depression when answered 'no' (questions 1, 5, 7, 11, 13). Each question received a score of 1 point when the response was indicative of depression. Total score ranged from 0 to 15. the total score ranged from 0-15, where 0 implies no symptoms and higher score implies more severity of symptoms.
Day 5 and 90
Mean Change in Transcranial Magnetic Stimulations (TMS) Evaluated by Peak to Peak MEP by % Stimulation Level
時間枠：Baseline (Day 1), Day 30 and 112
TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motorneurons. Motor threshold was recorded as the lowest stimulus intensity (in percent) eliciting motor evoked potentials (MEPs). Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post -randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline (Day 1), Day 30 and 112
Serum Levels of the S100β Protein
時間枠：Day 1 (Pre-dose, Post dose 1, 6, 24 hour), Day 5
The serum sample for S100β collected on Day 1 (predose, 1, 6, 12 and 24 hour) and Day 5 and was analyzed for levels. Serum levels of S100β protein were recorded as log transformed values therefore the negative values are reported.
Day 1 (Pre-dose, Post dose 1, 6, 24 hour), Day 5

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年7月8日

一次修了 (実際)

2011年1月31日

研究の完了 (実際)

2011年1月31日

試験登録日

最初に提出

2009年1月29日

QC基準を満たした最初の提出物

2009年1月29日

最初の投稿 (見積もり)

2009年2月2日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月17日

QC基準を満たした最後の更新が送信されました

2017年10月17日

最終確認日

2017年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 111539

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. インフォームド コンセント フォーム
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 研究プロトコル
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 個人参加者データセット
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. データセット仕様
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 注釈付き症例報告書
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 統計分析計画
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 臨床研究報告書
    情報識別子：111539
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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