A MULTI-CENTER, PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, CLINIC
A MULTI-CENTER, PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, CLINIC
批准号:
7724999
负责人:
TAHSEEN MOZAFFAR
金额:
$0.14万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-12-01 至 2008-11-30
关键词:
Am 80Amyotrophic Lateral SclerosisClinicComputer Retrieval of Information on Scientific Projects DatabaseData AnalysesDeteriorationDoseDouble-Blind MethodEvaluationFundingGrantInstitutionInterventionLengthManualsMinocyclineMuscleOutcome MeasurePatient RecruitmentsPatientsPhasePlacebo ControlPlacebosPreparationPublicationsQuality of lifeRandomizedRateResearchResearch PersonnelResourcesScoreSourceTelephoneTestingTimeUnited States National Institutes of HealthVisitVital capacityWeekdaydouble-blind placebo controlled trialfollow-uppill
中文摘要
这个子项目是众多研究子项目之一
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
The hypothesis that the current study will test is that minocycline slows the progressive deterioration of global function in patients with amyotrophic lateral sclerosis (ALS). The primary outcome measure is change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo. The study is 80 % powered to detect an 18% or greater reduction in the average slope of patients' ALSFRS-R scores over time. The secondary outcome measures are changes in manual muscle testing (MMT), forced vital capacity (FVC, percent predicted), quality of life (QOL) and survival.
This is an investigator-initiated, multi-center, phase III, randomized (1:1), double blind, placebo-controlled trial. The total study length is 48 months: Twenty-four months for patient recruitment, 4 months of serial monthly evaluations to determine baseline slopes of progression for each patient followed by 9 months of intervention (minocycline or placebo), and 11 additional months of survival follow-up, data analysis and preparation of publications. Subjects receive monthly evaluations during their 13 months of participation. Randomization will occur at the month 4 visit. During the first 3 weeks of the intervention phase (month 5) subjects receive an escalating dose of up to 8 pills (400 mg) per day as tolerated and have weekly phone contact.
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会议论文
Influence of NT5c1A antibodies on disease progression, clinical phenotype and blood and muscle biomarkers in sporadic Inclusion Body Myositis - A prospective evaluation
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批准号:10596154
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项目类别:
-
资助金额:$96.03万
-
财政年份:2021
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负责人:TAHSEEN MOZAFFAR
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依托单位:
Influence of NT5c1A antibodies on disease progression, clinical phenotype and blood and muscle biomarkers in sporadic Inclusion Body Myositis - A prospective evaluation
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批准号:10381454
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项目类别:
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资助金额:$115.9万
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财政年份:2021
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负责人:TAHSEEN MOZAFFAR
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依托单位:
UCI-NEXT, a NeuroNEXT site
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批准号:10192846
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项目类别:
-
资助金额:$30.9万
-
财政年份:2018
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负责人:TAHSEEN MOZAFFAR
-
依托单位:
UCI-NEXT, a NeuroNEXT site
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批准号:9983184
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项目类别:
-
资助金额:$30.9万
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财政年份:2018
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负责人:TAHSEEN MOZAFFAR
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依托单位:
UCI-NEXT, a NeuroNEXT site
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批准号:10407606
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项目类别:
-
资助金额:$30.9万
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财政年份:2018
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负责人:TAHSEEN MOZAFFAR
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依托单位:
A MULTICENTER STUDY FOR THE VALIDATION OF ALS BIOMARKERS
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批准号:8166934
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项目类别:
-
资助金额:$0.03万
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财政年份:2009
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负责人:TAHSEEN MOZAFFAR
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依托单位:
OPEN LABEL EXTENSION OF PROTOCOL AALS-001 (#AALS-001-OL) - ARIMOCLOMOL IN AMY
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批准号:7725027
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项目类别:
-
资助金额:$0.18万
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财政年份:2007
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负责人:TAHSEEN MOZAFFAR
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依托单位:
COMBINATION DRUG SELECTION TRIAL IN AMYOTROPHIC LATERAL SCLEROSIS
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批准号:7725029
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项目类别:
-
资助金额:$0.55万
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财政年份:2007
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负责人:TAHSEEN MOZAFFAR
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依托单位:
A MULTICENTER, DOSE RANGING SAFETY AND PHARMACOKINETICS STUDY OF ARIMOCLOMOL IN)
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批准号:7606647
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项目类别:
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资助金额:$2.02万
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财政年份:2006
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负责人:TAHSEEN MOZAFFAR
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依托单位:
COMBINATION DRUG SELECTION TRIAL IN AMYOTROPHIC LATERAL SCLEROSIS
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批准号:7606663
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项目类别:
-
资助金额:$0.85万
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财政年份:2006
-
负责人:TAHSEEN MOZAFFAR
-
依托单位:
OPEN LABEL EXTENSION OF PROTOCOL AALS-001 (#AALS-001-OL) - ARIMOCLOMOL IN AMY
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批准号:7606659
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项目类别:
-
资助金额:$1.05万
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财政年份:2006
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负责人:TAHSEEN MOZAFFAR
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依托单位:
AMYOTROPHIC LATERAL SCLEROSIS RESEARCH GROUP [ALS RG] COLLECTION OF DATA AND BI
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批准号:7606658
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项目类别:
-
资助金额:$1.67万
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财政年份:2006
-
负责人:TAHSEEN MOZAFFAR
-
依托单位:
A MULTI-CENTER, PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, CLINIC
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批准号:7606629
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项目类别:
-
资助金额:$4.3万
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财政年份:2006
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负责人:TAHSEEN MOZAFFAR
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依托单位:
RESEQUENCING THE VARIABLE HUMAN GENOME IN SPORADIC ALS: A NECESSARY PRELUDE TO
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批准号:7606662
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项目类别:
-
资助金额:$1.01万
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财政年份:2006
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负责人:TAHSEEN MOZAFFAR
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依托单位:
海外基金