Who is sponsoring NCT01422161?

NCT01422161 is sponsored by NYU Langone Health.

What condition does NCT01422161 study?

NCT01422161 studies Stroke With Hemiparesis.

What drugs are being tested in NCT01422161?

Interventions: Botulinum Toxin commonly known as BOTOX®, Placebo.

What is the status of NCT01422161?

NCT01422161 is currently COMPLETED.

Last reviewed 2019-06-04 · How we verify

Botulinum Toxin Type A Therapy as a Plasticity Inducing Agent for Recovery of Hand Function After Stroke

NCT01422161 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).

Details

Lead sponsor	NYU Langone Health
Phase	Phase 3
Status	COMPLETED
Enrolment	16
Start date	2010-04
Completion	2015-10

Conditions

Stroke With Hemiparesis

Interventions

Botulinum Toxin commonly known as BOTOX®
Placebo

Primary outcomes

Time Taken to Form a Stable Grasp Pre-Treatment — Day 1
Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
Time Taken to Form a Stable Grasp Post Treatment — 90 Days
* Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.

Countries

United States