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

NCT03005119 | Unknown Phase 2

• 1 other identifier: CS-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Incidence of study treatment-related adverse events (AE)

  10 weeks (70 days) from beginning of treatment to end of follow-up

• Change in sNRS scores from randomization to end of placebo-controlled treatment phase

  during the 4 weeks (28 days) placebo-controlled treatment period

Secondary Outcomes (10)

• Incidence of all AEs

  during 10 week treatment plus follow up period

• Percent change in walking velocity

  during 4 weeks placebo-controlled treatment period

• Clinical Global Impression Improvement (CGI-I) assessment using a 7-point scale condition

  at randomization (day 29) and the end of placebo-controlled treatment phase (day 57)

• Cadence (steps/min) assessment

  at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)

• Stride length (cm) assessment

  at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)

Other Outcomes (1)

• Combined modified Ashworth score (cMAS) and MS walking scale 12 (MSWS-12) assessments, posturography measure, Selected spatio-temporal parameters of gait

  at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)

Study Arms (2)

PTL201

EXPERIMENTAL

Up to 30 mg/day (30 mg THC, 10 mg CBD), recommended to be administered after meals and if required before bed time. Patients will be instructed not to take more than 10 mg (two capsules) at a single dosing session.

Drug: PTL201

Placebo

PLACEBO COMPARATOR

PTL201 and placebo capsules will be identical in appearance

Drug: Placebo Oral Capsule

Interventions

PTL201 DRUG

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

PTL201

Placebo Oral Capsule DRUG

Placebo seamless gelatin matrix green beads containing excipients only

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (male or female), age 18-65 years
• Definite diagnosis of MS, according to McDonald 2010 criteria, at least six months prior to enrollment, with MS associated spasticity for at least 3 months prior to enrollment
• Patients suffer from moderate to-severe MS-associated spasticity (≥4 sNRS), with no adequate response to traditional antispastic medications
• EDSS score: 4 ≤ EDSS ≤ 6; functional motor score ≥3.0 Safety, tolerability and efficacy of PTL201 in reducing multiple sclerosis-associated spasticity-related symptoms
• Moderate to severe spasticity in at least two districts of upper and/or lower limbs
• Anti-spasticity agent(s) and/or disease-modifying medications maintained at a stable dose for 30 days prior to and throughout the study
• Patients able to self-score spasticity
• Absence of clinical or neuroradiological relapses from at least three months prior to study entry
• Willingness and ability to provide written informed consent
• Willingness and ability to comply with all study requirements
• No major protocol violations were recorded for the patient in the responder phase and at least 20% improvement in sNRS

You may not qualify if:

• Concomitant disease or disorder with spasticity-like symptoms or that may influence the subject's level of spasticity, or medical history suggesting that relapse/remission is likely to recur during the study or expected to influence spasticity
• Currently using or used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain from using them for the duration of the study.
• Concurrent significant psychiatric, renal, hepatic,cardiovascular or convulsive disorders
• History or immediate family history of schizophrenia, other psychotic illness, severe personality disorder, or other significant psychiatric disorder other than depression related to MS/MS-associated spasticity.
• Any known or suspected history of substance abuse/dependence disorder (including opiate abuse),current heavy alcohol consumption, current use of illicit drug, or current non-prescribed use of any prescription drug.
• Poorly controlled epilepsy or recurrent seizures (i.e., one or more seizures in the past year).
• Known or suspected hypersensitivity to cannabinoids or to any of the excipients of the study drugs.
• Myocardial infarction or clinically significant cardiac dysfunction within 12 months of study entry or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
• Female patients of child-bearing potential and male patients whose partner is of childbearing potential, unless willing to ensure that they or their partner use effective contraception throughout the study and for three months thereafter
• Female patient who is pregnant, lactating, or planning pregnancy during the course of the study or within the 3 months thereafter.
• Any other significant diseases or disorder, which, in the opinion of the investigator, participation in the study may either put the patient at risk or may influence the result of the study, or the patient's ability to participate in the study.
• Travel outside the country planned during the study.
• Unwilling to abstain from donating blood during the study.
• Patients previously randomized into a cannabinoid-based clinical trial for MS pain and spasticity within 6 months of study entry.

Sponsors & Collaborators

• PhytoTech Therapeutics, Ltd.: lead

Study Sites (1)

Sheba medical center

Tel Hashomer, Ramat Gan, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hagit Sacks

CONTACT

+972 3 6449599; hsacks@mmjphytotech.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2016
• First Posted: December 29, 2016
• Study Start: March 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

IL (1)