NCT03005119

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

A Phase II, Double-blind, Randomized, Placebocontrolled, Parallel-group, Single-center Study to Evaluate the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in Multiple Sclerosis (MS) Patients With Spasticity-related Symptoms

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: PhytoTech Therapeutics, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be comprised of the following parts: 1. Pharmacokinetics (PK) sub-study: A 7-day baseline observation period. Randomized cross-over treatments (Sativex, PTL201), performed at minimum 7-day washout. Follow up - one week after the last dosing session. 2. Efficacy study: A 7-day baseline observation period. Single-blind responder phase - 4 weeks. Randomized, double-blind, placebo-controlled treatment phase - 4 weeks Follow up - two weeks. Subjects participating in the pharmacokinetic sub-study will be allowed to participate in the efficacy study and will not be required to repeat the 7-day observation period of the efficacy study. Doses will be titrated over a one-week period until reaching maximum tolerated dose (MTD) for each participant The MTD will be self administered for three weeks thereafter. Participants demonstrating response to treatment will continue self administering daily PTL201 treatment or placebo, for an additional four weeks. Participants will keep a daily diary.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	PTL201	Two piece acid resistance hard capsule filled with seamless gelatin matrix green beads containing tetrahydrocannabinol (THC) and cannabidiol (CBD). Each capsule contain 5 mg THC and 5 mg CBD
DRUG	Placebo Oral Capsule	Placebo seamless gelatin matrix green beads containing excipients only

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-12-29
• Last updated: 2017-09-28

Locations

1 site across 1 country: Israel