NL-OMON52032尚未招募3 期
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder - Troriluzole Long Term Safety Study in Subjects with OCD
Biohaven Pharmaceuticals Inc.0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Informed Consent:
- •a. Signed informed consent form prior to the initiation of any protocol
- •required procedures.
- •2. Age and Sex:
- •a. Male and female outpatient subjects between the ages of 18 - 65 upon entry
- •into BHV4157-302 or BHV4157-303.
- •3.Target Population:
- •a. Eligible subjects who complete study BHV4157-302 or BHV4157-303 and for whom
- •the investigator believes open-label treatment offers an acceptable
- •risk-benefit profile.
- •b.Determined by the investigator to be medically stable at the final visit of
- •BHV4157-302 or BHV4157-303, as assessed by medical history, physical
- •examination, laboratory test results, and electrocardiogram
- •c. Minimum of 6 years of education or equivalent to complete necessary scales
- •and understand consent forms;
- •d. Subjects must have adequate hearing, vision, and language skills to perform
- •neuropsychiatric testing and interviews as specified in the protocol;
- •e. Subjects must be able to understand and agree to comply with the prescribed
- •dosage regimens and procedures; report for regularly scheduled office visits;
- •and reliably communicate with study personnel about AEs and concomitant
- •medications;
- •f. Women of child bearing potential (WOCBP) and fertile men (including those
- •vasectomized for less than 6 months) with female partners who are WOCBP (not
- •having undergone bilateral tubal occlusion procedure and not post- menopausal)
- •must agree to use highly effective birth control, including two methods of
- •contraception, for the duration of the study.
- •g. The two methods should include:
- •i. one barrier method (e.g. diaphragm with spermicide, condom with spermicidal
- •gel, intrauterine devices, cervical cap);
- •ii. One other method that could include hormonal contraceptives (e.g. combined
- •estrogen and progesterone containing, or progesterone only with oral, vaginal,
- •injectable, or transdermal route of administration), intrauterine device, or
- •intrauterine hormone releasing system used for at least 4 weeks prior to sexual
- •intercourse (Section 5.5);
- •h. Women of childbearing potential must have a negative serum pregnancy test
- •throughout the study
- •i. It is required that men who are sexually active with WOCBP agree to use two
- •methods of contraception for the duration of the study (beginning at first
- •treatment and extending to 90 days after the last dose of study drug)
- •j. No clinically significant abnormality on the medical or laboratory
- •evaluation. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range may be included only if the investigator considers
- •that the finding is not clinically significant and will not introduce
- •additional risk factors and will not interfere with the study procedure
排除标准
- •1. Target Disease Exceptions
- •a.Subjects who did not successfully complete randomization phase in
- •BHV4157-302/BHV4157-303 study
- •b.Current or prior history of bipolar I or II disorder,schizophrenia or other
- •psychotic disorders,schizoaffective disorder,autism or autistic spectrum
- •disorders, borderline personality disorder,antisocial personality disorder,body
- •dysmorphic disorder,hoarding disorder (symptoms of hoarding disorder as part of
- •OCD diagnosis are allowed,but primary diagnosis of hoarding disorder is
- •excluded);current diagnosis of Tourette's disorder
- •c.Any eating disorder within last 12 months
- •d.Primary active major depressive episode or primary active anxiety disorder
- •within past 6 months
- •e.Acute suicidality or suicide attempt or self injurious behavior in last 12
- •f. Any positive Columbia Suicide Severity Rating Scale response to questions
- •1-5 at baseline(final visit of BHV4157-302/BHV4157-303) unless,after evaluation
- •of subject at Week 10 visit,investigator believes subject should continue in
- •study and that open-label treatment offers acceptable risk-benefit profile
- •g.Patients who plan to receive non-biological or biological investigational
- •agent in while enrolled in trial
- •h.History of psychosurgery,Deep Brain Stimulation or Electroconvulsive Therapy
- •2.Medical History Exclusions:
- •a.History of substance use disorder(drug or alcohol) in last 12 months,with
- •exception of tobacco,as defined by DSM-5 criteria
- •bPositive urine drug screening (UDS) for cannabis (both medical and
- •recreational use of cannabis are prohibited):, amphetamines (including
- •MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at study entry.
- •c.Prior or current general medical condition that may confound ability to
- •interpret safety and efficacy results as determined by Investigator
- •d.Clinical history of stroke,seizure disorder,traumatic brain injury with
- •ongoing sequelae
- •e.Patients with history of Type I or Type II insulin-dependent diabetes mellitus
- •f.Active liver disease or history of hepatic intolerance to medications that,in
- •investigator's judgment, is medically significant
- •g.Any unstable cardiovascular(includes uncontrolled
- •hypertension),pulmonary,gastrointestinal, or hepatic disease at study entry
- •h.End-stage cardiovascular disease(e.g.,Congestive Heart Failure New York Heart
- •Association Class III or IV or unstable angina)
- •i.History of chronic pulmonary disease or chronic pulmonary symptoms; well
- •controlled asthma is allowed per investigator's clinical judgement;
- •j.Immunocompromised subjects.Subjects taking systemic immunosuppressive agent
- •may be entered in trial only if they are on stable dose,have no clinically
- •relevant immunosuppression,and have white blood count within normal limits
- •k.History of medically significant gastrointestinal illnesses including:
- •i.Current diagnosis of active,peptic ulceration or gastrointestinal bleeding
- •and/orchronic inflammatory bowel disease at study entry;
- •ii.History of any gastrointestinal surgery that impacts absorption of study
- •iii.Chronic or frequent episodes of loose stools
- •l.History or evidence of any medical,neurological or psychological condition
- •that would expose subject to undue risk of significant AE or interfere with
- •assessments of safety and efficacy during course of trial
- 另有 1 项未显示
研究者
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