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临床试验/NCT00711516
NCT00711516已完成4 期

Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea

Cephalon9 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
9
主要终点
Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patient has a current diagnosis of OSAHS and has a complaint of excessive sleepiness despite effective nCPAP therapy.
  • •Patient has excessive sleepiness as evidenced by a mean sleep latency of less than 8 minutes, as determined by the MSLT.
  • •Patient has an ESS score of 10 or more at the initial screening visit.
  • •Patient has a habitual sleep time beginning no earlier than 2100 and ending no later than
  • •Patient is right-handed. Patients who are ambidextrous may be eligible following consultation with the medical monitor.
  • •Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
  • •Patient exhibits reasonable accuracy (≥80%) on the 2-back working memory task during the training session at the second screening visit.

排除标准

  • •The Patient:
  • •The patient is a current smoker or has a prior history of smoking (defined as ≥1 pack-year) within 2 years prior to the screening visit.
  • •consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 400 mg of caffeine per day (approximately equivalent to 4 or more cups of coffee).
  • •has NART-predicted verbal IQ and QIDS-SR16 scores within protocol-specific exclusionary ranges.
  • •has a clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated).
  • •has a confirmed or probable diagnosis of a current sleep disorder other than OSAHS.
  • •has used any excluded prescription drugs or procedures for prohibited and allowed drugs within the excluded timeframe.
  • •has a history of alcohol, narcotic, or any other drug abuse.
  • •has a positive UDS, without medical explanation, at the screening visit.
  • •has a clinically significant deviation from normal in the physical examination.
  • •is a pregnant or lactating woman. Any woman becoming pregnant during the study will be withdrawn from the study.
  • •has a past or present seizure disorder, head trauma that is clinically significant, or past neurosurgery.
  • •has used an investigational drug within 1 month before the screening visit.
  • •has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
  • •has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
  • •has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
  • •has known human immunodeficiency virus (HIV).
  • •has clinical laboratory test value(s) outside the range(s) specified in the Protocol, or presents a clinically significant laboratory abnormality without prior written approval by the medical monitor.
  • •has worked the night shift within 28 days of the baseline visit, or will work the night shift during the double-blind segment of the study.
  • •anticipates any travel across more than 3 time zones at any time during the study.
  • •needs to use any of the excluded medications identified in this protocol.
  • •is unable to complete neuroimaging studies, performance tasks, self-rating scales, and all other study assessments.
  • •has a contraindication to fMRI scanning, (such as an implanted pacemaker/defibrillator, aneurysm clips, drug infusion device or metallic foreign body).
  • •is suspected to be unable to tolerate fMRI scanning (eg, claustrophobic) and/or the testing paradigm.
  • •has physical or other characteristics that suggest imaging data will be unobtainable or degraded.

研究组 & 干预措施

1

Experimental

Armodafinil treatment (200 mg/day) - Study drug was supplied as 50 mg tablets and the dose was titrated from a starting dose of 50 mg taken once daily in the morning (before 0800), increasing to 100 mg/day on Day 2, 150 mg/day on day 5, and then 200 mg/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.

干预措施: Armodafinil (Drug)

2

Placebo Comparator

Placebo comparator - Placebo tablets matching the armodafinil 50 mg tablets drug were supplied and the dose was titrated from a starting dose of one tablet taken once daily in the morning (before 0800), increasing to two tablets/day on Day 2, three tablets/day on day 5, and then four tablets/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation

时间窗: Baseline and Endpoint (Week 2 or last observation after baseline)

The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p\<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.

次要结局

  • Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Epworth Sleepiness Scale Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint(Endpoint (Week 2 or last observation after baseline))
  • Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint(Week 2 or Last Observation after Baseline)
  • Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint(Week 2 or Last Observation after Baseline)
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State(Baseline and Endpoint (Week 2 or last observation after Baseline))
  • Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State(Baseline and Endpoint (Week 2 or last observation after Baseline))
  • Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State(Baseline and Endpoint (Week 2 or last observation after Baseline))
  • Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State(Baseline and Endpoint (Week 2 or last observation after Baseline))
  • Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State(Baseline and Endpoint (Week 2 or last observation after baseline))
  • Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test(Baseline and Endpoint (Week 2 or last observation after Baseline))

研究者

发起方
Cephalon
申办方类型
Industry
责任方
Sponsor

研究点 (9)

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