CLINICAL TRIAL

BOTOX for Tremor

Recruiting · 18+ · All Sexes · Montreal, Canada

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

See full description

About the trial for Tremor

Eligible Conditions
Tremor · Essential Tremor · Upper Limb Essential Tremor (UL ET)

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.

Experimental Group 1
Placebo for BOTOX
DRUG
+
BOTOX
BIOLOGICAL
Experimental Group 2
Placebo for BOTOX
DRUG
+
BOTOX
BIOLOGICAL
Experimental Group 3
BOTOX
BIOLOGICAL
Show More

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BOTOX
2013
Completed Phase 4
~500

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol.
TETRAS Archimedes spiral task score > 2 in the dominant limb.
TREDS-Revised Scale (1-4 scale) unilateral score of >= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb.
You have at least 3 of the 5 unilateral items in the dominant limb. show original
The Essential Tremor Rating Assessment Scale (TETRAS) upper limit (UL) score (0-4 scale) > 2 in the dominant limb on at least one of the 3 maneuvers. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 18
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 18
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 18.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Change From Baseline in TETRAS Archimedes Spiral Score
WEEK 18
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Archimedes Spiral is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to draw an unbroken spiral which is then scored from 0 to 4, with 1 being tremor is "barely visible" and 4 being "figure not recognizable."
WEEK 18
Change From Baseline in Tremor Disability Scale-Revised (TREDS-R) Total Score Across 7 Unilateral Items
WEEK 18
Tremor Disability Scale-Revised (TREDS-R) is a scale to assess activities of daily living (ADL) through a self-questionnaire asking participants to rate how easy or difficult it is to perform a particular activity. The scale consists of 20 items with each item rated on a scale of 1 (able to do the activity without difficulty) to 4 (cannot do the activity by yourself). 7 items included in this subset will be: use a spoon to drink soup, hold a cup of tea, pour milk from a bottle or carton, dial a telephone, pick up your change in a shop, insert an electric plug into a socket, unlock your front door with a key.
WEEK 18
Change From Baseline in TETRAS Handwriting Score
WEEK 18
TETRAS Handwriting is an item of the TETRAS performance subscale that is designed to assess tremor severity. During this test, participants are instructed to write the standard sentence "This is a sample of my best handwriting" using the dominant hand only, which is then scored from 0 to 4 with 1 being tremor is "slight: untidy due to tremor that is barely visible" and 4 being "severe: completely illegible."
WEEK 18
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
WEEK 18
CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale where "0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe."
WEEK 18
Change From Baseline in Patient Global Impression of Severity (PGI-S)
WEEK 18
PGI-S is a single item used to measure the participant's impression of severity of their essential tremor symptoms. The measure uses a 5-point rating scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
WEEK 18
Change From Baseline in Essential Tremor Rating Assessment (TETRAS UL) Score
WEEK 18
TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor during three maneuvers: forward horizontal reach posture, lateral "wing beating" posture, and finger-nose-finger testing. Each maneuver is scored from 0 to 4, with 1 indicating a tremor amplitude that is "barely visible" and 4 indicating a tremor amplitude that is >= 20 cm.
WEEK 18
See More

Patient Q & A Section

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

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Tremor by sharing your contact details with the study coordinator.