EUCTR2015-003929-34-GB进行中（未招募）1 期
A Pilot Double-blind, Placebo-controlled Crossover Study to Explore the Possible Benefit of AUT00063, an Oral Modulator of Voltage-gated Potassium Channels, in Adult Post-lingual Unilateral Cochlear Implant Recipients: The QuicK+fire-study - QuicK+fire-P study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
入选标准
- •Subjects fulfilling the following criteria are eligible for participation in the study:
- •(1) Male or female aged = 18 years.
- •(2) Native English speaking.
- •(3) Received a unilateral cochlear implant within the last 9 to 36 months for post-lingual deafness.
- •There are no restrictions regarding the encoding algorithm; subjects will have a MED-EL, Cochlear® or Advanced Bionics CI device.
- •(4) Aged = 18 years at the time of the CI surgery.
- •(5) Fully trained and optimised at the time of enrolment.
- •(6) CI device working satisfactorily and with at least 80% of electrode array functioning and mapped.
- •(7) Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 85% for Bamford-Kowal-Bench (BKB) sentences presented in quiet without contralateral hearing aid).
- •(8) No interventions (e.g. alterations to coding/optimisation or speech therapy) in the 4 weeks prior to the first dose of study medication.
- •(9) Signed and dated informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects who meet one or more of the following criteria are not eligible:
- •(1) Not able to understand and comply with the requirements of the study.
- •(2) CI undertaken primarily for the management of severe tinnitus.
- •(3) Tinnitus with a Tinnitus Handicap Inventory (THI) score >36.
- •(4) Moderate or severe depression or generalised anxiety as indicated by a score of =11 out of 21 on the Hospital Anxiety and Depression Scale (HADS).
- •(5) Currently taking or planning to take medications that are prohibited by the study protocol; see Protocol Section 7.4.8. I.e. (1) CNS-penetrant concomitant medication for the management of severe insomnia (over-the-counter and prescribed sedatives for mild insomnia are allowed), major depressive disorder, severe anxiety, or post-traumatic stress disorder; (2) medication for the management of tinnitus; (3) CYP3A4 inhibitors (strong or moderate) and CYP3A4 inducers; and (4) CYP2C9 substrates with a narrow therapeutic range (cf. IB, Section 7).
- •(6) History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the investigator and which might be jeopardized by entering the study; investigator’s discretion to define, with advice from the sponsor if requested.
- •(7) Clinically significant ECG abnormality or prolonged QT interval.
- •(8) Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
- •(9) History of hypersensitivity or idiosyncratic reaction to any named component of the test medication.
- •(10) Any acute disabling illness.
- •(11) Clinically significant alcohol or drug abuse, in the opinion of the Investigator or self-reported on intake form.
- •(12) Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug (whichever is longer) prior to consenting to study entry.
- •(13) History of poor cooperation, non-compliance with medical treatment, or unreliability.
- •(14) For women: Pregnant or nursing.
- •(15) For men and women: Not willing or able to use adequate methods of contraception; i.e. male subjects who are sexually active must use a barrier method of contraception unless have undergone a vasectomy; female subjects must comply with 2 reliable methods of contraception or be of non-child-bearing potential (post-menopausal with an absence of menstrual bleeding for at least 12 months or permanently surgically sterilized). See also Protocol Section 7.4.11, Diet, prohibitions, and other instructions for subjects
研究者
相似试验
招募中
2 期
Desmopressin for the Treatment of Orthostatic Hypotension and Excessive Nighttime Urination in Parkinson’s DiseaseOrthostatic HypotensionocturiaNocturiaNeurological - Other neurological disordersRenal and Urogenital - Other renal and urogenital disordersNeurological - Parkinson's diseaseParkinson's DiseaseACTRN12609000080224John O'Sullivan20
进行中（未招募）
1 期
Double-blind, cross-over, placebo-controlled pilot study to characterize the profile of those patients with traumatic spinal cord injury diagnosed by electrophysiological, urodynamic and clinical (ASIA group) assesment who may respond to vardenafil treatment. - LEMDEErectile dysfunction (ED)EUCTR2004-005282-37-ESQUIMICA FARMACEUTICA BAYER, S.A.
已完成
不适用
A Double Blinded, Placebo Controlled, Crossover Infusion Study of Respiratory Pharmacodynamics of ENA-001 in Conjunction with Propofol, Hypoxia, and HypercapniaNL-OMON50050Enalare Therapeutics Inc.12
进行中（未招募）
1 期
A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia GravisPatients with MuSK Antibody Positive Myasthenia GravisMedDRA version: 19.1Level: LLTClassification code 10062976Term: Neuromuscular weaknessSystem Organ Class: 100000004859EUCTR2015-003127-62-ITFONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA20
进行中（未招募）
1 期
A Double-Blind, Placebo-Controlled, Crossover Pilot Study of the Efficacy and Safety of Fluasterone Buccal Tablet in the Control of Hyperglycemia in Adults with Endogenous Cushing’s SyndromeCushing SyndromeCTIS2023-508322-10-00Sterotherapeutics LLC24