Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Solstice Neurosciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Botulinum toxin has long been used as a clinical application for the treatment of overactive skeletal and smooth muscles, i.e. spasticity. The benefits of botulinum therapy are indisputable, however, muscle atrophy is one main adverse effect that may hinder a patient's strength and decrease the ability for the practitioner to accurately administer botulinum toxin to a specific muscle group. This, in turn may cause unintentional weakness of adjacent muscle groups through inaccurate targeting or diffusion of botulinum toxin. Currently, only two serotypes (abbreviated to BTX-A (BOTOX, XEOMIN and DYSPORT) and BTX-B (MYOBLOC), respectively) are used in clinical practice for spasticity. Research has shown that both BTX-A and BTX-B are efficacious in the treatment of spasticity. However, there is no documented literature evaluating if there is a statistically significant difference in the degree of muscle atrophy using BTX-A versus BTX-B.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Active Comparator | Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit. |
|
| MYOBLOC | Active Comparator | Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume and Cross-Sectional Area of Muscle | The present pilot study is designed to assess the extent to which BTX-A (BOTOX) and BTX-B (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. Patient will complete a MRI of the tested muscle at baseline and at the end of the study. The MRI will be completed and read by the same radiologist throughout the study to account for inter rater variability. Note: The radiologist will be blinded to study treatment. | 36 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale | The secondary endpoint is improvement in spasticity using the Modified Ashworth Scale. We will review all measures with our statistician. Modified Ashworth scoring will be completed at every visit to evaluate the extent of spasticity before, during and after treatment of which will be conducted by the same rater throughout course of the study. | 36 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fernando Pagan, MD | MedStar Georgetown University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 17, 2018 | |
| Reset | Sep 12, 2018 | |
| Release | Mar 18, 2019 | |
| Reset | Apr 9, 2019 | |
| Release | Jan 21, 2020 | |
| Reset | Jan 30, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 17, 2018 | Sep 12, 2018 | |||
| Mar 18, 2019 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013119 | Spinal Cord Injuries |
| D001930 | Brain Injuries |
| D009369 | Neoplasms |
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C096323 | rimabotulinumtoxinB |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MYOBLOC | Drug | Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit. |
|
|
| Apr 9, 2019 |
| Jan 21, 2020 | Jan 30, 2020 |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |