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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-151607-DP | Experimental | Participants will receive AGN-151607-DP. |
|
| Placebo for AGN-151607-DP | Placebo Comparator | Participants will receive Placebo for AGN-151607-DP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151607-DP | Drug | Intramuscular Injection |
| |
| Placebo for AGN-151607-DP |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) | TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor). | 72 weeks |
| Number of Participants with Adverse Events (AEs) | 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. | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL) | 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. | 72 weeks |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Pain Research Center /ID# 277899 | Recruiting | Fresno | California | 93710 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Drug |
Intramuscular Injection |
|
| Change From Baseline in Clinical Global Impression of Severity (CGIS) |
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. |
| 72 weeks |
| Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277079 |
| Recruiting |
| Boca Raton |
| Florida |
| 33486 |
| United States |
| Charter Research - Winter Park /ID# 277875 | Recruiting | Orlando | Florida | 32803-1839 | United States |