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This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-Placebo Group | Active Comparator | Treatment on 0 day Placebo at 5th week |
|
| Placebo-Treatment Group | Active Comparator | Placebo on 0 day Treatment at 5th week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditoxin | Drug |
| ||
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week. | 0, 16, 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in numerical rating scale (NRS) | Pain in numerical rating scale (NRS) | Every 4 weeks, up to 32 weeks |
| Japanese Orthopaedic Association (JOA) score | Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | vital sign, adverse effect | Every 4 weeks, up to 32 weeks |
| computed tomography (CT) | Change of cervical spine computed tomography (CT) from baseline CT at 0 week. |
Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 8, 2018 | |
| Reset | Jun 7, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 8, 2018 | Jun 7, 2018 |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Every 4 weeks, up to 32 weeks |
| Goal attainment scale | Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks. | 4, 12, 20, 28 weeks |
| 0, 32 weeks |
| videofluoroscopic swallowing study (VFSS) | Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week. | 0, 12, 28 weeks |
| Blood/Urine laboratory tests |
| 0, 16, 32 weeks |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |