drugset / Trial / NCT03005119
Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the safety and tolerability of oral administration of PTL201 for relief of spasticity-related symptoms in 70 MS patients and to evaluate the efficacy of oral administration of PTL201 in relief of spasticity-related symptoms in MS patients. The pharmacokinetics of PTL201 in comparison to buccally administered Sativex will be evaluated in sub-study prior to the efficacy study.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2018-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 5 mg | Oral |
| Subject | Dronabinol | Other / unclassified | 5 mg | Oral |