BOTOX for Tremor
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
See full descriptionAbout the trial for Tremor
Treatment Groups
This trial involves 4 different treatments. BOTOX is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether BOTOX will improve 1 primary outcome and 6 secondary outcomes in patients with Tremor. Measurement will happen over the course of Week 18.
Patient Q & A Section
What is tremor?
Tremor is a involuntary, repetitive, rhythmic and predictable muscle movement that affects 1 in 2 people. In normal, healthy people, tremor is seen as slow and can often be observed as a'smoothing effect' during walking and other motor activities. Tremor is one of the most common symptoms of Parkinson's disease. The tremors seen in parkinson disease are often different to dystonias. Dystonia is a movement disorder that can affect the hands, arms and fingers.
What are common treatments for tremor?
Tremor management is complicated, and generally involves more than one avenue of treatment. This may not be possible because of the large number of medications being used to prevent or control tremor. However, it is often possible to reduce symptoms or control tremors by using medications with a greater effect. Current medications include dopamine antagonists (antipsychotics and antidepressants), L-dopa, benzodiazepines (clonazepam is commonly used), beta blockers (beta 1 - and 2 -adrenergic antagonists and norepinephrine-reuptake inhibitors), anticonvulsants (triacetyl anticonvulsants), dopamine agonists, and alpha-2 adrenergic receptors agonists.
How many people get tremor a year in the United States?
Around 300,000 people are diagnosed a year with tremor in the United States. In the U.S. this is the second most common movement disorder after essential tremor.\n
Can tremor be cured?
Tremor can be reduced in some cases to such a degree that it is manageable. In such patients, it is a major problem and should be addressed during evaluation, irrespective of whether the tremors are part of a generalized movement disorder (e.g. PD) or are of specific origin (e.g. essential tremor).
What are the signs of tremor?
Abnormal postures are the hallmark of tremor. A careful assessment of these features can help in ruling out other neurologic etiologies. The head impulse test (HIT) is an ideal tool for diagnosing patients with tremor.
What causes tremor?
The present findings suggest that tremor may be associated with a range of conditions other than essential tremor or Parkinson's disease, and that tremor seen in patients with dementia may reflect vascular pathology rather than underlying degenerative neurological disease.
Is botox typically used in combination with any other treatments?
Botox is most commonly used in combination with neuromuscular blockade, especially neuraxial blockade. The use of botulinum toxin in combination with neuromuscular blockers should be considered as an effective option for patients.
What are the common side effects of botox?
The common side effects of botulinum toxin therapy reported in clinical trials are summarized. Injection-site effects (pruritus) were the most common, and in almost all studies reporting itching, most subjects reported it was mild or moderate. Commonly reported injectable side effects include erythema, soreness, and erythema multiforme at the local injection site. The time course of these symptoms was short, and they were typically mild and well tolerated. These mild, local injection-site effects were the most frequent reason patients were administered a second or subsequent injection, although itching remained common thereafter. Rare but serious consequences associated with botulinum toxin injection include tendon rupture, hemophagocytic syndrome, and death.
Have there been any new discoveries for treating tremor?
The number of medications has not changed significantly since the early 1980s. A drug that seemed promising may have been discontinued due to adverse effects or low efficacy. The recent research suggests that the tremor is caused by multiple parts of the brain and the nervous system. Further research is needed to determine whether other neural pathways play a role in the tremor-inducing processes. Moreover, medications are tested in short and in long-term trials to find the most effective drug for those with tremor.
How does botox work?
The botulinum toxin is an effective therapy in treating essential tremor. In this condition, a large injection of botulinum toxin is administered either directly into the tremor muscles or into a 'cannula' in which the injection is performed during a neurophysiologic study. Injections are typically performed over one or more visits each four to 10 weeks apart and repeated twice a year. In nearly all patients, botulinum toxin injection into the tensor tympani muscle provides a permanent response.
Who should consider clinical trials for tremor?
Clinicians' perspectives on patient eligibility, decisional framework, and outcomes measurement need refinement with a greater focus on tremors of all etiologies as well as tremors without neurologic involvement. As evidence suggests, tremor is a debilitating disease with a significant impact on patients' lives, yet it receives little consideration in clinical trials, which are often insensitive to tremor.
What is the primary cause of tremor?
Primary tremors are usually provoked by environmental factors and have no underlying organic cause. There are many secondary or 'essential' tremors, which are not linked to any identifiable cause. Tremor can cause significant problems to daily activities. The cause of a primary tremor is not always identified; for whatever reason, a tremor might not disappear on its own.\n