drugset / Trial / NCT03929068

Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis

NCT03929068

Phase 1 Completed 15 enrolled Washington University School of Medicine
RandomizedCrossoverDouble-blindTreatment

Summary

Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in ALS and PLS patients with severe spasticity should be studied. The investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in ALS and PLS patients.

Timeline

Start
2019-05-13
Primary completion
2022-07-08
Completion
2022-07-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbidopa Unknown 25 mg Oral
Comparator Levodopa Small molecule 100 mg Oral