Upper Limb Essential Tremor
Conditions
Keywords
Upper Limb Essential Tremor, AGN-151607-DP
Brief summary
Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating. This study will assess if AGN-151607-DP is safe and effective by assessing adverse events and change in disease activity in adult participants with UL ET. AGN-151607-DP is an investigational drug being developed to treat UL ET. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 94 adult participants with upper limb essential tremor will be enrolled in approximately 40 sites in the United States/Canada. Participants will receive intramuscular injections of AGN-151607-DP or matching placebo. Duration of the study is approximately 72 weeks. The effect of the treatment will be checked by completion of questionnaires and side effects will be monitored by medical assessments.
Interventions
DRUGAGN-151607-DP
Intramuscular Injection
Intramuscular Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Minimum body weight of 50 kg (110 pounds) at Screening. * Diagnosis of essential tremor (ET) in accordance with the modified Tremor Research Investigation Group (TRIG) criteria, as follows: * Bilateral postural tremor with or without kinetic tremor, involving hands and forearms * Tremor of other body parts may or may not be present in addition to upper limb (UL) tremor * Bilateral tremor may or may not be asymmetric * Tremor that is reported by the participant to be persistent, although the amplitude may fluctuate.
Exclusion criteria
* History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular junctional disorders. * History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and/or other botulinum toxins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) | 72 weeks | TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor). |
| Number of Participants with Adverse Events (AEs) | 72 weeks | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL) | 72 weeks | TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor. Items are scored from 0 to 4, with 0 indicating no tremor and 4 indicating a severe tremor. |
| Change From Baseline in Clinical Global Impression of Severity (CGIS) | 72 weeks | 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 with scores ranging none to very severe. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed