EUCTR2010-023963-16-IT进行中（未招募）不适用
A Placebo-Controlled, Double-Blind RandomizedWithdrawal Study to Evaluate the Safety and Efficacy ofCNV1014802 in Patients with Trigeminal Neuragia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •A patient will be eligible for inclusion in this study only if all of the
- •following criteria apply:
- •1. IHS criteria for trigeminal neuralgia to be used. The diagnosis must be
- •verified by a member of the diagnostic sub-committee of the DMC before
- •the patient is entered into the study.
- •A diagnosis of trigeminal neuralgia. Pain must be unilateral, and
- •characterized by brief electric shock-like pains, abrupt in onset and
- •termination, limited to the distribution of one or more divisions of the
- •trigeminal nerve. Pain is commonly evoked by trivial stimuli including
- •washing, shaving, smoking, talking and/or brushing the teeth(trigger
- •factors), and frequently occurs spontaneously. The attacks start and end
- •rapidly. There is often no pain between each bout of pain and many
- •bouts can occur every day. There is often a refractory period between
- •attacks. Some patients may report some after pain after the severe pain
- •for a few minutes.
- •Pain remissions occur where there can be weeks or months of no pain
- •even when medications are stopped.
- •The following diagnostic criteria for trigeminal neuralgia must be met:• Paroxysmal attacks of pain lasting from a fraction of a second to 2
- •minutes, affecting one or more divisions of the trigeminal nerve and
- •fulfilling criteria b and c.
- •Pain has at least one of the following characteristics:
- •i. Intense, sharp, superficial or stabbing
- •ii. Precipitated from trigger areas or by trigger factors
- •Attacks are stereotyped in the individual patient
- •There is no clinically evident neurological deficit
- •Not attributed to another disorder
- •2. Frequency criteria for numbers of paroxysms:
- •Patients must have suffered a minimum of 3 or more paroxysms of
- •pain per day, rated at an intensity of 4 or more on the pain NRS, on at
- •least 4 days during the last 7 days prior to entry into the open-label
- •treatment period.
- •3. Male or female between 18 and 70 years of age inclusive, at the time
- •of signing the informed consent.
- •4. A female patient is eligible to participate if she is of:
- •Non-childbearing potential defined as pre-menopausal females with a
- •documented tubal ligation or hysterectomy; or postmenopausal defined
- •as 12 months of spontaneous amenorrhea [in questionable cases a blood
- •sample with simultaneous follicle stimulating hormone (FSH) = 25.8
- •MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
- •Females on hormone replacement therapy (HRT) and whose menopausal
- •status is in doubt will be required to use one of the contraception
- •methods in Section 7.5 if they wish to continue their HRT during the
- •Child-bearing potential and agrees to use one of the contraception
- •methods listed in Section 0 for an appropriate period of time (as
- •determined by the product label or investigator) prior to the start of
- •dosing to sufficiently minimize the risk of pregnancy at that point.
- •Female patients must agree to use contraception until 3 days post-last
- •5. Male patients must agree to use one of the contraception methods
- •listed in Section 7.5. This criterion must be followed from the time of the
- •first dose of study medication until 14 days post-last dose.
- 另有 7 项未显示
排除标准
- •Patients who are known non-responders to sodium channel blockers at
- •therapeutic doses.
- •Patients with causes for their facial pain other than that specified in
- •Inclusion Criterion
- •A positive pre-study drug screen.
- •A positive history of HIV.
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis Cantibody result within 3 months of screening.
- •History of any liver disease within the last 6 months, with the
- •exception of known Gilbert's disease.
- •History of excessive regular alcohol consumption within 6 months of
- •Patients with a history or risk of seizures or a history of epilepsy, head
- •injury or related neurological disorders
- •Patients with a history of uncontrolled or poorly controlled
- •hypertension, with systolic BP frequently exceeding 160mmHg and/or
- •diastolic BP frequently exceeding 100mmHg, or patients who have BP
- •greater than or equal to 160mmHg systolic and/or greater than
- •or equal to 100mmHg diastolic at screening after repeated
- •measurements
- •History or presence of significant cardiovascular, gastrointestinal, or
- •renal disease or other condition known to interfere with the absorption,
- •distribution, metabolism,
- •or excretion of drugs.
- •Patients with conditions known to affect cardiac conduction or a
- •personal or familial history of Brugada syndrome
- •Pregnant females or lactating females.
- •History or presence of any clinically significant
- •abnormality in vital signs / ECG / laboratory tests or have any medical
- •or psychiatric condition, which, in the opinion of the Investigator may
- •interfere with the study
- •procedures or compromise patient safety.
- •History of suicidal ideation and/or suicide attempts or clinical evidence
- •of recent major depression.
- •Patients who are unable to maintain approved
- •medications for their trigeminal neuralgia at a stable dose during the
- •Unable to refrain from excessive use of sedatives.
- •Unable to comply with the prohibited concomitant medication
- •restrictions as detailed in the protocol. This includes but is not limited to
- •sodium channel blockers or drugs that adversely interact with a
- •monoamine oxidase-
- •B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic
- •History of hypersensitivity to CNV1014802.
- •The patient has participated in a clinical trial and has received an
- •investigational product within 5 half-lives or twice the duration of the
- •biological effect of the investigational product (whichever is longer)
- •prior to the start of this study.
- •Exposure to more than four new chemical entities (medications for
- •which no marketing authorization has been obtained) within 12 months
- •prior to the first dosing day.
- •Where participation in the study would result in total donation of blood
- •or blood products in excess of 500mL within a 56 day period.
- 另有 2 项未显示
研究者
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