Clinical Trial Details
| Trial ID: | L7096 |
| Source ID: | NCT03238898 |
| Associated Drug: | Botulinum Toxin Type A |
| Title: | Botulinum Toxin for Cramps in Diabetic Neuropathy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Muscle Cramps Aggravated|Diabetes Mellitus |
| Interventions: | DRUG: Botulinum toxin type A|OTHER: Normal saline |
| Outcome Measures: | Primary: pain intensity on a 0-10 severity scale, the intensity of pain was rated on a scale 0 to 10, with 0 indicating no pain and 10 indicating "the worst pain imaginable", 20 weeks | Secondary: cramp frequency, the changes in cramp frequency, the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A administration, 20 weeks|the Cramp Severity Scale (CSS), the changes in the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A administration, 20 weeks|the Cramp Threshold Frequency (CTF), the changes in the Cramp Threshold Frequency were evaluated over the course of 20 weeks after BoNT/A administration, 20 weeks |
| Sponsor/Collaborators: | Sponsor: Presidio Ospedaliero Garibaldi-Centro |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 50 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT |
| Start Date: | 2014-09-27 |
| Completion Date: | 2017-05-03 |
| Results First Posted: | |
| Last Update Posted: | 2017-08-03 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT03238898 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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