EUCTR2010-023963-16-DE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
- 70
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:
- •a. 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.
- •b. Pain has at least one of the following characteristics:
- •i. Intense, sharp, superficial or stabbing
- •ii. Precipitated from trigger areas or by trigger factors
- •c. Attacks are stereotyped in the individual patient
- •d. There is no clinically evident neurological deficit
- •e. 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 80 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 study.
- •Child-bearing potential and agrees to use one of the contraception methods listed in Section7.5 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 dose.
- •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.
- •6. Body weight = 50 kg for men and = 45 kg for women.
- •7. BMI =34.9.
- •8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to the commencement of any study related procedures.
- •9. Three ECGs taken at least 5 min apart should be performed at
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 C antibody 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 the study.
- •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 study.
- •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 agents.
- •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.
- •Patient is mentally or legally incapacitated.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
研究者
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