Clinical trial · Interventional
Myobloc Atrophy Study
NCT02052024CI-TRIAL-00020217MAScompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injury | — | UNRESOLVED | — |
| Spasticity Secondary to Either a Disorder or Trauma | — | UNRESOLVED | — |
| Spinal Cord Injury (SCI) | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Botox | Drug | — | UNRESOLVED |
| MYOBLOC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Botox
- description
- Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit.
- interventionNames
- Drug: Botox
- type
- ACTIVE_COMPARATOR
- label
- MYOBLOC
- description
- Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit.
- interventionNames
- Drug: MYOBLOC
Primary outcomes (1)
- measure
- Volume and Cross-Sectional Area of Muscle
- timeFrame
- 36 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged 18 or older with spasticity secondary to either a disorder or trauma, such as a spinal cord injury (SCI), a brain injury, a tumor, a stroke, multiple sclerosis (MS), or a peripheral nerve injury. * Participants must have the ability to provide written consent to participate in the study. Exclusion Criteria: * Patients who have received BTX-A or BTX-B in the past in the skeletal muscle group under investigation or patients who have had an allergic response to BTX-A or BTX-B in the past. * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis. Females who are pregnant or breastfeeding. Subjects taking Aminoglycosides or other agents interfering with neuromuscular function.
References
Publications (0)
Data not yet available
No reference posted for this study.