BXCL501 for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
BioXcel Clinical Research Site, Orem, UT
Schizophrenia+8 More
BXCL501 - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called BXCL501 can help reduce agitation in children and adolescents.

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Eligible Conditions

  • Schizophrenia
  • Bipolar Disorder I
  • Bipolar Disorder, Type II
  • Schizoaffective Disorders
  • Schizophreniform; Schizophrenic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether BXCL501 will improve 1 primary outcome and 1 secondary outcome in patients with Schizophrenia. Measurement will happen over the course of 120 minutes.

120 minutes
Primary End Point
90, 60, 45, 30, 20,10 minutes
Key Secondary End Point

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

80 Micrograms
1 of 3
120 Micrograms
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 3 different treatment groups

This trial involves 3 different treatments. BXCL501 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

80 Micrograms
Drug
Sublingual film containing 80 micrograms Dexmedetomidine
120 Micrograms
Drug
Sublingual film containing 120 micrograms Dexmedetomidine
Placebo
Drug
Sublingual Placebo film

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90, 60, 45, 30, 20,10 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90, 60, 45, 30, 20,10 minutes for reporting.

Closest Location

BioXcel Clinical Research Site - Orem, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study includes both male and female subjects aged 10-17 years who have bipolar disorder according to DSM-5 criteria, and aged 13-17 years who have schizophrenia according to DSM-5 criteria. show original
Patients who are judged to be clinically agitated and have a total score of ≥14 on the 5 items that make up the PANSS Excited Component. show original
are exempt from the requirement to use a condom show original
Patients who have a score of ≥ 4 on any of the 5 items on the PEC at Baseline. show original

Patient Q&A Section

What are common treatments for disease?

"There are several common treatments for disease. The most common treatment for pain such as diabetic neuropathy, is opioids and antineuronal agents. Chronic disease such as coronary heart disease, is treated with aspirin and medication used to lower blood pressure and blood cholesterol levels. A treatment for chronic heart failure is to help the patient remain active and healthy by providing support for the patient to do regular physical activities to lower blood pressure and cholesterol levels." - Anonymous Online Contributor

Unverified Answer

What causes disease?

"There are many different diseases that can lead to a fatal illness. If you do not want to die, and you get sicker and sicker, you need a doctor. There is no one way to get better. It seems crazy, but in a lot of ways it's the world we construct. I've got plenty of luck in this life, and I'd be happy to take it." - Anonymous Online Contributor

Unverified Answer

Can disease be cured?

"It is impossible to restore a nondiseasurable health condition to an absolute health state. It is possible to do as close as possible to that state without restoring the patient to complete health. That is to say, it is possible with reasonable medical care to make a patient healthier, and not to make it healthy." - Anonymous Online Contributor

Unverified Answer

What is disease?

"The term disease has been given many different meanings since ancient times. It is more useful to view disease as a process whereby the organism behaves differently to its ancestors and different from its peers and descendants or where the organism responds differently to the environment. Disease can be defined as any condition or event in an organism that significantly compromises its normal biological functions.\n\nIt has been suggested that, to have a sense, the expression of disease must be socially constructed and not only determined by a biological process. The social construction of disease, therefore, is a fundamental aspect of biological pathogenesis. Within the discipline of medical anthropology, the concept of disease has been interpreted in many ways." - Anonymous Online Contributor

Unverified Answer

How many people get disease a year in the United States?

"The American Cancer Society estimates about 200,000 deaths from cancer a year in the United States. Cancer deaths are more likely to occur after the age of 65. In the United States, cancer is now the most common disease-related cause of death. The rate of cancer death is highest in the 20- to 44-year age group and then declines to a steady level with age. Survival times are lengthened in blacks and for females aged 46 to 54 years, with the exception of colon cancer, in women aged 45 to 49 years old." - Anonymous Online Contributor

Unverified Answer

What are the signs of disease?

"The authors concluded with their recommendation to pay attention to the following signs or symptoms as they might suggest or help to differentiate lung problems from respiratory diseases: breathlessness, cough, chest pain, abnormal chest X-ray appearance, loss of appetite, vomiting, a low or fast heart rate, abnormal breathing sounds, sweating, or diarrhea.\n\nInfection is not necessarily a sign of disease. In fact, the infections that are linked to an increased risk of developing disease can be of benefit to the body.\nInfection is also associated with an increased risk of developing cancer and other diseases. It is thought that both the body's immune system and infection by microbes can affect immune response to the body." - Anonymous Online Contributor

Unverified Answer

What is bxcl501?

"Bxcl501 is an experimental drug that targets blood and brain barrier permeability thereby lowering intracerebral edema and hemorrhage. It is being studied in clinical trials by Novartis for the treatment of intracerebral hemorrhage." - Anonymous Online Contributor

Unverified Answer

What does bxcl501 usually treat?

"The majority of respondents described their overall treatment experience with Bxcl501 as supportive and effective. They also reported that Bxcl501 was most effective for treatment of BXD2. In all, 80% of respondents described their treatment with Bxcl501 with improvement or stabilization of symptoms, and in 93% of cases there was an appreciable effect on life expectancy. These responses are in line with results from published clinical trials. Overall, Bxcl501 was well tolerated, and treatment was mostly discontinued or interrupted based on tolerability or side effects." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in bxcl501 for therapeutic use?

"The bxcl501 molecules present a highly successful antiviral strategy against human T-lymphotropic-virus type 1 HIV-related neurosarcoidosis. Bxcl501 is working in vivo in an animal model of neurosarcoidosis, and phase I and II human clinical trials have indicated that this may be a promising approach for treating the disease. In conclusion, these studies are ongoing, and further developments are expected." - Anonymous Online Contributor

Unverified Answer

How serious can disease be?

"The risk of death associated with asthma is not as high as doctors expected, even in young children who experience serious health problems. Doctors and patients should agree on the disease severity index to help direct the health-care team toward management of health problems, particularly in low-resource settings without access to care for patients in need of medical services." - Anonymous Online Contributor

Unverified Answer

Is bxcl501 safe for people?

"Bxcl501 was well tolerated and showed activity in patients with advanced ovarian cancer previously treated or in combination with paclitaxel and doxorubicin. A prospective clinical trial in early-stage ovarian cancer with this regimen is now ongoing." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bxcl501?

"Bxcl501 is not associated with any serious side effect but does have common side effects, such as headache, dizziness and blurred vision. The side effects can be controlled and managed by the patients and healthcare professionals. [power(https://www.withpower." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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