drugset / Trial / NCT03005119

Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms

NCT03005119

Phase 2 Unknown 70 enrolled PhytoTech Therapeutics, Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 5 mg Oral
Subject Dronabinol Other / unclassified 5 mg Oral

Indications