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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03005119
• Date of registration: 25/12/2016
• Prospective Registration: Yes
• Primary sponsor: PhytoTech Therapeutics, Ltd.
• Public title: Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms
• Scientific title: 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
• Date of first enrolment: March 1, 2018
• Target sample size: 70
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03005119
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Anat Achiron, Prof.

• Name: Hagit Sacks

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient (male or female), age 18-65 years

2. 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

1. Patients suffer from moderate to-severe MS-associated spasticity (=4 sNRS), with
no adequate response to traditional antispastic medications

2. EDSS score: 4 = EDSS = 6; functional motor score =3.0 Safety, tolerability and
efficacy of PTL201 in reducing multiple sclerosis-associated spasticity-related
symptoms

3. Moderate to severe spasticity in at least two districts of upper and/or lower
limbs

3. Anti-spasticity agent(s) and/or disease-modifying medications maintained at a stable
dose for 30 days prior to and throughout the study

4. Patients able to self-score spasticity

5. Absence of clinical or neuroradiological relapses from at least three months prior to
study entry

6. Willingness and ability to provide written informed consent

7. Willingness and ability to comply with all study requirements

8. Inclusion criteria for placebo-controlled treatment phase:

No major protocol violations were recorded for the patient in the responder phase and at
least 20% improvement in sNRS

Exclusion Criteria:

1. 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

2. 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.

3. Concurrent significant psychiatric, renal, hepatic,cardiovascular or convulsive
disorders

4. 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.

5. 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.

6. Poorly controlled epilepsy or recurrent seizures (i.e., one or more seizures in the
past year).

7. Known or suspected hypersensitivity to cannabinoids or to any of the excipients of the
study drugs.

8. 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

9. 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

10. Female patient who is pregnant, lactating, or planning pregnancy during the course of
the study or within the 3 months thereafter.

11. 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.

12. Travel outside the country planned during the study.

13. Unwilling to abstain from donating blood during the study.

14. Patients previously randomized into a cannabinoid-based clinical trial for MS pain and
spasticity within 6 months of study entry.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: PTL201

Drug: Placebo Oral Capsule

Primary Outcome(s)

Change in sNRS scores from randomization to end of placebo-controlled treatment phase [Time Frame: during the 4 weeks (28 days) placebo-controlled treatment period]

Incidence of study treatment-related adverse events (AE) [Time Frame: 10 weeks (70 days) from beginning of treatment to end of follow-up]

Secondary Outcome(s)

Sleep disturbance assessment [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

Incidence of all AEs [Time Frame: during 10 week treatment plus follow up period]

Percent change in walking velocity [Time Frame: during 4 weeks placebo-controlled treatment period]

Assessment of clinical gait measures [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

Cadence (steps/min) assessment [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

Clinical Global Impression Improvement (CGI-I) assessment using a 7-point scale condition [Time Frame: at randomization (day 29) and the end of placebo-controlled treatment phase (day 57)]

Stride length (cm) assessment [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

pNRS assessment [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

Spasm frequency assessment [Time Frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)]

Secondary ID(s)

CS-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors