EUCTR2009-014545-83-ES进行中（未招募）不适用
A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury - ?Estudio de 12 semanas, aleatorizado, doble-ciego controlado con placebo, de grupos paralelos con dosis fijas para evaluar la eficacia y la seguridad de Armodafinil (50, 150 y 250 mg/día) en el tratamiento de pacientes con somnolencia excesiva asociada a un trauma cráneo-cerebral no penetrante leve o moderado - C10953/3067/ES/M
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 620
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- mild (Glasgow Coma Scale [GCS] score 13-15) or moderate (GCS 9-12) closed TBI at the time of injury, and injury occurred 1 to 10 years prior to screening. TBI is defined as traumatically induced physiologic disruption of brain function as manifested by 1 of the following:
- •any period of LOC, any loss of memory for events immediately before or after the accident, any alteration of mental state, focal neurological deficits (may or may not be transient)
- •- the patient has a Glasgow Outcome Scale score of 5 at the screening visit
- •- the patient has an ESS score of at least 10 at screening
- •- the patient has a mean sleep latency on the MSLT (average of 4 naps) of less than 8 minutes at baseline
- •- the patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating relating to their excessive sleepiness of 4 or more at the screening and baseline visits
- •- the patient has a complaint of excessive sleepiness (at least 5 days/week on average) for at least 3 months, and the excessive sleepiness began within 12 months of the TBI
- •- written informed consent is obtained
- •- the patient is a man or woman of any ethnic origin 18 to 65 years of age
- •- if admitted to an in-patient treatment facility, the patient was discharged at least 1 month prior to the screening visit
- •- the patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness
- •- Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of one of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, mplanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
- •- the patient is in otherwise good health, as judged by the investigator, on the basis of a medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, and urinalysis
- •- the patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol
- •- the patient has Mini-Mental State Exam (MMSE) score of more than 26 at the screening visit
- •- the patient is on stable dosages of medications (allowed by the protocol) for a minimum of 8 weeks before the screening visit and is not likely to require a change in therapy for at least 12 weeks on the basis of the investigators? assessment.
- •- the patient has had no more than 1 head injury fulfilling the criteria for TBI
- •- the patient has a habitual bedtime between 21:00 and 23:00
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- the patient has a history of 2 or more episodes of transient loss of consciousness without clear medical explanation, or has a history of known or suspected pseudoseizure (psychogenic seizure). Patients with a history of seizure or epilepsy may be eligible following discussion with the medical monitor
- •- the patient requires, or is likely to require, treatment with anticonvulsant medication during the study; or has taken anticonvulsant medication within 6 months before the screening visit
- •- the patient has an unstable or uncontrolled medical (including illnesses related to the cardiovascular [including patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome]), renal, or hepatic systems or surgical condition (treated or untreated) or is not a suitable candidate for treatment with armodafinil, as judged by the investigator
- •- the patient has had neurosurgery involving the brain or brainstem
- •- the patient has a history of schizophrenia, bipolar disorder, psychotic depression, or other psychotic episode
- •- the patient has any current Axis I disorder (including depression and posttraumatic stress disorder [PTSD]) or any Axis II disorder, that in the opinion of the investigator would affect patient participation in the study or full compliance with study procedures
- •- the patient has a history of, or currently meets ICSD-2 criteria for narcolepsy, OSAHS, SWSD, or any other sleep disorder associated with excessive daytime sleepiness; or the patient has a history of idiopathic hypersomnia, insomnia (requiring treatment), or sleep disorder before the development of the TBI
- •- the patient has 85% or less sleep efficiency as determined from NPSG
- •- the patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion
- •- the patient has used any medications including OTC medicines disallowed by the protocol within 7 days or 5 half-lives (medication or its active metabolites), whichever is longer, before the baseline visit
- •- the patient has a need for chronic pain medications
- •- in the judgment of the investigator, the patient has a clinically significant deviation from normal in the physical examination
- •- in the judgment of the investigator, the patient has any clinically significant ECG
- •- the patient has a diagnosis of any type of dementia
- •- the patient has a history of suicidal ideation (considered to be currently clinical significant), or is currently suicidal
- •- the patient has a known hypersensitivity to Armodafinil, racemic modafinil, or any component of the study drug tablets
- •- the patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
- •- the patient has a clinical laboratory test value(s) outside the range(s) specified below, and medical monitor has not provided written approval for study participation:
- •? hemoglobin <110 g/L (11.0 g/dL) (men) or <100 g/L (10.0 g/dL) (women)
- •? absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)
- •? platelet count <100 x 109/L (<100000/mm3)
- •? sodium <130 mEq/L
- •? potassium >5.5 mEq/L
- •? glucose >200 mg/dL (unless a repeat measurement of glucose in the fasting state is <140 mg/dL)
- •? creatinine clearance <60 mL/min (calculated by the Cockcroft-Gault formula)
- •? aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpe
研究者
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