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Part 1: ABBV-950 Dose A for Upper Limb Spasticity

Phase 1 & 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified Ashworth Scale-Bohannon (MAS-B) score of >= 3 in the wrist flexors, and a score of >= 1+ in the finger flexors and MAS-B score of >= 2 elbow flexors at both Screening and Visit 2 (Baseline).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24

Awards & highlights

Study Summary

This trial is testing a drug called ABBV-950 to see if it is safe and effective in treating muscle tightness and stiffness in the upper limbs (spasticity) in adults who have

Who is the study for?

Adults with upper limb spasticity due to a stroke that happened at least 12 weeks before screening can join this trial. They must have certain levels of muscle tightness in their wrist, finger, and elbow flexors. People who don't meet these specific muscle tightness criteria cannot participate.Check my eligibility

What is being tested?

The study is testing ABBV-950's safety and effectiveness for treating arm stiffness after a stroke. Participants will either get ABBV-950, BOTOX, or a placebo through shots in the muscles. The trial has two parts: one tests different doses of ABBV-950 against placebo; the other compares BOTOX, ABBV-950, and placebo directly.See study design

What are the potential side effects?

Possible side effects from injections like ABBV-950 or BOTOX may include pain at the injection site, swelling, bruising, muscle weakness near where the drug was injected, headache or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My muscle stiffness in my wrist, fingers, and elbow is moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B)

Number of Participants Experiencing Adverse Events

Secondary outcome measures

Change in Clinician Global Impression of Change (CGI-C) Score

Change in Clinician Global Impression of Severity (CGI-S) Score

Percentage of Participants Achieving Wrist MAS-B Responder Status

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part 2: ABBV-950 Dose CExperimental Treatment1 Intervention

Participants will receive ABBV-950 Dose C on Day 1.

Group II: Part 2: ABBV-950 Dose BExperimental Treatment1 Intervention

Participants will receive ABBV-950 Dose B on Day 1.

Group III: Part 2: ABBV-950 Dose AExperimental Treatment1 Intervention

Participants will receive ABBV-950 Dose A on Day 1.

Group IV: Part 1: ABBV-950 Dose CExperimental Treatment1 Intervention

Participants will receive ABBV-950 Dose C on Day 1.

Group V: Part 1: ABBV-950 Dose BExperimental Treatment1 Intervention

Participants will receive ABBV-950 Dose B on Day 1.

Group VI: Part 1: ABBV-950 Dose AExperimental Treatment1 Intervention

Participants will receive ABBV-Dose A on Day 1.

Group VII: Part 2: BOTOX Dose AActive Control1 Intervention

Participants will receive BOTOX Dose A on Day 1.

Group VIII: Part 1: Placebo for ABBV-950 Dose APlacebo Group1 Intervention

Participants will receive placebo for ABBV-950 on Day 1.

Group IX: Part 1: Placebo for ABBV-950 Dose BPlacebo Group1 Intervention

Participants will receive placebo for ABBV-950 on Day 1.

Group X: Part 1: Placebo for ABBV-950 Dose CPlacebo Group1 Intervention

Participants will receive placebo for ABBV-950 on Day 1.

Group XI: Part 2: Placebo for ABBV-950Placebo Group1 Intervention

Participants will receive placebo for ABBV-950 on Day 1.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,093 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,812 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of individuals receiving treatment within this specific clinical trial?

"Indeed, the data available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The trial was initially posted on January 12th, 2024 and underwent its most recent update on January 16th, 2024. In order to complete the study successfully, a total of 297 patients will be enrolled across four different sites."

Answered by AI

Are patients currently eligible to participate in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this investigation is actively seeking potential participants. The trial was initially posted on January 12th, 2024 and underwent its most recent update on January 16th, 2024. In total, they aim to recruit a cohort of 297 patients from four distinct sites."

Answered by AI

Does the inclusion criteria of this research study encompass individuals who are 75 years of age or older?

"This clinical research study is seeking individuals who are over 18 years old but below the age of 80."

Answered by AI

Are there several medical facilities within the United States that are currently involved in conducting this clinical trial?

"This particular clinical trial is currently being conducted at 4 sites. These include locations in Washington, Downey, and Stamford, as well as an additional 4 other cities. To minimize travel obligations for participants, it would be advantageous to choose the site closest to their residence when enrolling."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity

2024. "Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05956509.