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Brainsway (BWAY)
:BWAY
Brainsway Dtms With Intermittent Theta Burst Stimulation (Itbs), Brainsway Dtms With High Frequency (Hf) Stimulation
Major Depressive Disorder
Phase IV
Completed
Brainsway DTMS for Treatment of MDD Using iTBS
Dec 17, 2020
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Sham Treatment, Active Dtms Treatment
Smoking Cessation
Phase III
Completed
Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
Apr 27, 2014
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Deep Transcranial Magnetic Stimulation
Tinnitus
Phase II
Withdrawn
Deep TMS of the Left Auditory Cortex Using the HMCIPCC Coil, in the Treatment of Patients With Tinnitus.
Jan 28, 2014
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Deep Tms
Machado Joseph Disease (Sca3)
Phase II
Completed
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
Dec 29, 2013
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Tms
Effect Of Deep Transcranial Magnetic Stimulation On Memory
Early Phase I
Withdrawn
Facilitating Associative Memory Via Deep Transcranial Magnetic Stimulation to the Medial Temporal Lobe
May 07, 2012
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H-Coil Deep Tms, Sham Coil Tms
Mild Cognitive Impairment
Phase I
Unknown
Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment
Oct 25, 2011
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Transcranial Magnetic Stimulation
Autism
Phase II
Terminated
Deep rTMS (Repetitive Transcranial Magnetic Stimulation)for Treatment of Autism Symptoms in Children.
Jun 27, 2011
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Treatment By Hlpfc Coil
Attention Deficit Hyperactivity Disorder
Phase I
Unknown
Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults
Sep 07, 2010
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Tms, H Coil
Alzheimer's Disease
Phase II
Completed
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Aug 08, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Brainsway (BWAY) have in its pipeline
BWAY is currently developing the following drugs: Brainsway Dtms With Intermittent Theta Burst Stimulation (Itbs), Brainsway Dtms With High Frequency (Hf) Stimulation, Sham Treatment, Active Dtms Treatment, Deep Transcranial Magnetic Stimulation. These drug candidates are in various stages of clinical development as the company works toward FDA approval.