Phase 3
Completed N=16
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Stroke With Hemiparesis
Source: ClinicalTrials.gov NCT01422161 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Time Taken to Form a Stable Grasp Pre-Treatment — 1.51; 1.14 Preload phase duration in Seconds
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken to Form a Stable Grasp Pre-Treatment |
1.51; 1.14 | — |
| PRIMARY Time Taken to Form a Stable Grasp Post Treatment |
2.65; .79 | — |
| SECONDARY Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale |
47.6; 40.7 | — |
| SECONDARY Disability Measured by Modified Rankin Scale Score Post-Treatment |
2; 1.8 | — |
| SECONDARY Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment |
52.1; 45.5 | — |
| SECONDARY Disability Measured by Modified Rankin Scale Score Pre-Treatment |
2.3; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to follow study instructions and likely to complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- 3 months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
- Must have ability to grasp and lift the test object
- Subjects must have upper extremity motor impairment
Exclusion Criteria
- Known allergy or sensitivity to botulinum toxin type A (BOTOX).
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
- Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
- Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
- Infection or skin disorder at an anticipated injection site.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Current treatment with intrathecal baclofen.
Data sourced from ClinicalTrials.gov (NCT01422161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.