Brivaracetam for Neoplasms, Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Rochester Medical Center, Rochester, NY
Neoplasms, Brain+1 More
Brivaracetam - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

See full description

Eligible Conditions

  • Neoplasms, Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Brivaracetam will improve 1 primary outcome and 1 secondary outcome in patients with Neoplasms, Brain. Measurement will happen over the course of 6 Months.

6 Months
Safety of Brivaracetam
Voluntariness for study participation

Trial Safety

Side Effects for

Brivaracetam
Headache
25%
Dizziness
21%
Somnolence
14%
Nasopharyngitis
14%
Influenza
13%
Upper respiratory tract infection
11%
Diarrhoea
10%
Urinary tract infection
10%
Depression
10%
Back pain
10%
Convulsion
10%
Pyrexia
10%
Nausea
10%
Vomiting
9%
Arthralgia
8%
Fatigue
8%
Pain in extremity
7%
Cough
7%
Insomnia
7%
Hypertension
7%
Anxiety
7%
Irritability
6%
Fall
6%
Tremor
6%
Constipation
6%
Abdominal pain
6%
Toothache
6%
Laceration
5%
Contusion
5%
Decreased appetite
5%
Rash
5%
Suicide attempt
1%
Toxicity to various agents
1%
Pneumonia
1%
Transient ischaemic attack
1%
Status epilepticus
1%
Pregnancy
1%
Hydronephrosis
0%
Cerebral infarction
0%
Brain cancer metastatic
0%
Cellulitis staphylococcal
0%
Bradycardia
0%
Supraventricular tachycardia
0%
Drug ineffective
0%
Anaemia
0%
Lymphadenopathy
0%
Chest pain
0%
Appendicitis
0%
Haemorrhoids
0%
Vertigo
0%
Myocardial infarction
0%
Gastric fistula
0%
Unevaluable event
0%
Meningitis tuberculous
0%
Ankle fracture
0%
Comminuted fracture
0%
Abdominal pain upper
0%
Angina unstable
0%
Rectal haemorrhage
0%
Gastrooesophageal reflux disease
0%
Intestinal obstruction
0%
Sudden unexplained death in epilepsy
0%
Myocardial ischaemia
0%
Malaria
0%
Multi-organ failure
0%
Cellulitis
0%
Disseminated tuberculosis
0%
Gastroenteritis viral
0%
Hip fracture
0%
Non-cardiac chest pain
0%
Coccidioidomycosis
0%
Gastroenteritis
0%
Intestinal perforation
0%
Splenic artery aneurysm
0%
Escherichia sepsis
0%
Mastoiditis
0%
Cholecystitis acute
0%
Tooth abscess
0%
Neurocysticercosis
0%
Brain contusion
0%
Abdominal injury
0%
Dengue fever
0%
Osteomyelitis
0%
Encephalitis herpes
0%
Periorbital cellulitis
0%
Pyelonephritis
0%
Lobar pneumonia
0%
Lung infection
0%
Animal bite
0%
Malignant pleural effusion
0%
Humerus fracture
0%
Pelvic inflammatory disease
0%
Accident
0%
Rickettsiosis
0%
Viral infection
0%
Sepsis
0%
Ulna fracture
0%
Burns third degree
0%
Hyponatraemia
0%
Epilepsy
0%
Anastomotic ulcer
0%
Uterine leiomyoma
0%
Subdural haematoma
0%
Thermal burn
0%
Weight increased
0%
Hyperammonaemia
0%
Craniocerebral injury
0%
Procedural hypotension
0%
Femur fracture
0%
Anticonvulsant drug level increased
0%
Hypoproteinaemia
0%
Tendon rupture
0%
Radius fracture
0%
Wrist fracture
0%
Non-small cell lung cancer
0%
Prostate cancer
0%
Ligament sprain
0%
Upper limb fracture
0%
Foot fracture
0%
Post procedural haematoma
0%
Hypokalaemia
0%
Osteonecrosis
0%
Gastrointestinal tract adenoma
0%
Cerebrovascular accident
0%
Thyroid cancer
0%
Ataxia
0%
Subdural haemorrhage
0%
Dehydration
0%
Pregnancy on contraceptive
0%
Renal cell carcinoma
0%
Central nervous system lesion
0%
Partial seizures
0%
Weight decreased
0%
Intervertebral disc degeneration
0%
Lung adenocarcinoma metastatic
0%
Metastatic bronchial carcinoma
0%
Abortion spontaneous
0%
Pregnancy on oral contraceptive
0%
Joint instability
0%
Scrotal disorder
0%
Osteoarthritis
0%
Ovarian germ cell teratoma benign
0%
Grand mal convulsion
0%
Oesophageal cancer metastatic
0%
Metabolic encephalopathy
0%
Major depression
0%
Ovarian epithelial cancer
0%
Brain neoplasm
0%
Lipoma
0%
Seizure cluster
0%
Completed suicide
0%
Dysfunctional uterine bleeding
0%
Colon cancer metastatic
0%
Complicated migraine
0%
Psychotic disorder
0%
Schizophrenia
0%
Ocular neoplasm
0%
Unintended pregnancy
0%
Renal failure acute
0%
Small cell lung cancer stage unspecified
0%
Calculus urinary
0%
Asthma
0%
Calculus ureteric
0%
Small intestine carcinoma metastatic
0%
Paranoia
0%
Suicidal ideation
0%
Hypoxia
0%
Pneumonia aspiration
0%
Hemiparesis
0%
Postictal state
0%
Renal failure
0%
Self-injurious ideation
0%
Dyspnoea
0%
Foetal death
0%
Benign prostatic hyperplasia
0%
Asphyxia
0%
Abortion
0%
Menorrhagia
0%
Dyspnoea exertional
0%
Pneumothorax
0%
Abnormal behaviour
0%
Hallucination
0%
Ovarian cyst
0%
Lung infiltration
0%
Aggression
0%
Pulmonary embolism
0%
Respiratory failure
0%
Pulmonary congestion
0%
Abortion induced
0%
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT00150800) in the Brivaracetam ARM group. Side effects include: Headache with 25%, Dizziness with 21%, Somnolence with 14%, Nasopharyngitis with 14%, Influenza with 13%.

Trial Design

1 Treatment Group

Experimental
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Brivaracetam is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Experimental
Drug
Brivaracetam at a dose of 50 mg twice daily for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brivaracetam
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
T. W.
Prof. Thomas Wychowski, Associate Professor - Department of Neurology , Epilepsy (SMD)
University of Rochester

Closest Location

University of Rochester Medical Center - Rochester, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor Patients must be able to provide informed consent

Patient Q&A Section

What are common treatments for neoplasms, brain?

"There are no single treatments for neoplasms, brain that are widely used or even acceptable. The most commonly used treatments for neoplasms, brain are radiotherapy, chemotherapy with chemotherapy drugs such as methotrexate, 5-fluorouracil, carboplatin, or irinotecan, surgical resection and corticosteroids." - Anonymous Online Contributor

Unverified Answer

What causes neoplasms, brain?

"The brain is exposed to high levels of radiation and pollutants during infancy. These factors increase the risk of developing benign neoplasms and secondary brain tumors in adulthood.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of neoplasms, brain?

"Brain tumours may cause headaches, speech problems, vomiting or seizures. In children, an unsteady gait or loss of fine motor skills may be signs of brain tumours. A headache at the same place as the tumour could be signs of a brain tumour." - Anonymous Online Contributor

Unverified Answer

How many people get neoplasms, brain a year in the United States?

"Approximately 4.0 million US citizens are diagnosed with brain cancer and 2.5 million die of the disease annually. However, the number of individuals affected can reach up to 50% amongst those who survive brain cancer.\n" - Anonymous Online Contributor

Unverified Answer

What is neoplasms, brain?

"Brain neoplasms are rare and are usually associated with a history of neurological disease. These diseases include epilepsy, epilepsy-related intracranial lesions, and demyelinating syndromes. When CNS neoplasms are suspected, evaluation of CT, MRI, and PET scan results is mandatory." - Anonymous Online Contributor

Unverified Answer

Can neoplasms, brain be cured?

"Neither can neoplasms, nor brain be cured from all causes. These concepts have to rely on rigorous protocols for diagnostic and therapeutic management, as well as intensive support from professionals to enable the patient to cope with the pain until he is free from it." - Anonymous Online Contributor

Unverified Answer

Does neoplasms, brain run in families?

"In the majority of families with neoplasms involving the brain, the predisposition is autosomal dominant. The risk for neoplasms of the brain in siblings with neoplasms of the kidney is approximately 50% with autosomal dominance and 10% with the recessive mode. There remain unanswered questions regarding the genetic influences on neoplasms of brain, the mechanism of renal adenomatoblastomas, and the relevance of the occurrence of neoplasms of the brain in families with neoplasms of the kidneys." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating neoplasms, brain?

"A new treatment has been developed for acute leukemia, a neoplasm of chronic immune disease. It is a highly specific fusion protein-targeted small molecule antineoplastic (a targeted anticancer drug). It shows promise of being an effective treatment for this devastating disease. This new treatment can be used to treat patients under current standard treatments, and is in phase II testing to determine its safety and efficacy." - Anonymous Online Contributor

Unverified Answer

Has brivaracetam proven to be more effective than a placebo?

"Although brivaracetam shows promise in improving cognitive functioning in patients with nonmotor symptoms of Alzheimer's disease, the results were in the range of that seen in healthy elderly controls. However, results in subcortical atrophy and neuropsychiatric disturbances were promising, but were restricted to a single pilot trial. Further randomized, controlled trials are needed to establish brivaracetam as an effective alternative to placebo." - Anonymous Online Contributor

Unverified Answer

How quickly does neoplasms, brain spread?

"An additional study is needed to establish the relation between the age of the patient and the time to spread of brain metastasis if one exists. At present there is no relation: that is, when a patient is younger than 55 years and the metastatic lesion is small, brain metastasis should not spread, while for tumors larger than the size of a walnut, metastasis is more common among patients aged 55-65 years." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for neoplasms, brain?

"Although the survival rate in children and adolescents is generally excellent, in young adults with brain tumors, it is significantly poorer. There should be a focus on early diagnosis and treatment for children with brain tumors." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for neoplasms, brain?

"Patients with neurologic deficits that are reversible or treatable may benefit from clinical trials. Clinicians should be aware that some cancer trials for neoplasms do not provide any benefit, but many of those that do provide benefit cannot be used to treat patients owing to ethical issues." - 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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