EUCTR2021-001337-40-ES进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER - Agitation associated with schizophrenia and bipolar disorder in children
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •1.Male and female subjects between the ages of 10-17 years, inclusive, in subjects with bipolar disorder and 13-17 years, inclusive, in subjects with schizophrenia.
- •2.Subject or legally acceptable representative (per local regulatory requirements for the legal age of consent for study participation) is able to sign and date written ICF prior to the start of any study-specific qualification procedures.
- •3.Subject meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subject meets DSM-5 criteria for bipolar disorder (bipolar I or II ).
- •4.Subject assessed to be clinically agitated at Screening and Baseline with a total score of =14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).
- •5.Subject has a score of =4 on at least 1 of the 5 items on the PEC at Baseline.
- •6.Subject is in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the investigator.
- •7.Female subjects, if of child-bearing potential and sexually active, and male subjects, if sexually active with a partner of child-bearing potential, agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study.
- •Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device, condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and progestin implant or injection. Prohibited methods include the rhythm method, withdrawal, condoms alone, or diaphragm alone.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •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
- •1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
- •2. Subjects with ADHD treated with an alpha2-adrenergic agonist (clonidine, guanfacine).
- •3. Subjects with agitation that cannot be attributed to schizophrenia or bipolar disorder (bipolar I or II) as diagnosed by DSM-5 criteria.
- •4. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- •5. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
- •6. Subjects with significant risk of suicide or homicide per the investigator’s assessment, or any subject with an answer of yes” to item 4 or 5 on the C-SSRS.
- •7. Female subjects who have a positive pregnancy test at Screening.
- •8. Subjects who have hydrocephalus, seizure disorder, or history of significant head trauma, brain tumor, or meningitis.
- •9. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension, or a baseline heart rate of <55 beats per minutes (bpm) or a resting systolic/diastolic blood pressure (DBP) of <90/60 mmHg at Screening and before dosing.
- •10. Subjects with laboratory or ECG abnormalities considered clinically significant by the investigator or qualified designee that would have clinical implications for the subject’s participation in the study.
- •11. Subjects with serious or unstable medical illnesses. These include current hepatic impairment (moderate-severe), or renal, respiratory, endocrinologic, or hematologic disease.
- •12. Subjects who have received an investigational drug within 30 days prior to the current agitation episode.
- •13. Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving dexmedetomidine, e.g., subjects with a history of allergic reactions to dexmedetomidine.
- •14. Subjects with a history of atrioventricular block.
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