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

NCT03005119 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-09-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • PhytoTech Therapeutics, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Israel

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005119 on ClinicalTrials.gov