Multiple SclerosisPhase 2NCT03005119
Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms
A Phase 2 study testing PTL201 in people with Multiple Sclerosis, run by PhytoTech Therapeutics, Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PTL201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2018to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Tel Hashomer, Ramat Gan
Anat Achiron, Prof., Anat.Achiron@sheba.health.gov.il
About this study
Official 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
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.
Read the detailed description
The study will be comprised of the following parts:
- 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.
- 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
- Being tested
- PTL201, Placebo Oral Capsule
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTL201Drug
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
Placebo Oral CapsuleDrug
Placebo seamless gelatin matrix green beads containing excipients only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PTL201 |
| Placebo | Placebo comparator | PTL201 and placebo capsules will be identical in appearance Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of study treatment-related adverse events (AE)
Measured: 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
Measured: during the 4 weeks (28 days) placebo-controlled treatment period
Secondary outcomes (10)
Incidence of all AEs
Measured: during 10 week treatment plus follow up period
Percent change in walking velocity
Measured: during 4 weeks placebo-controlled treatment period
Clinical Global Impression Improvement (CGI-I) assessment using a 7-point scale condition
Measured: at randomization (day 29) and the end of placebo-controlled treatment phase (day 57)
Cadence (steps/min) assessment
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Stride length (cm) assessment
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
pNRS assessment
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Spasm frequency assessment
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Sleep disturbance assessment
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Assessment of clinical gait measures
Timed (sec) 25 foot walk test (T25FW)
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Assessment of clinical gait measures
Timed (sec) up and go test (TUG)
Measured: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Mar 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhytoTech Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005119
- Sponsor's protocol ID
- CS-101
- Status last verified
- Sep 2017
- First submitted
- 25 Dec 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03005119
- Acronym / sponsor ID
- CS-101
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- PhytoTech Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTL201 | Experimental | Drug: PTL201Up 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. |
| Placebo | Placebo comparator | Drug: Placebo Oral CapsulePTL201 and placebo capsules will be identical in appearance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTL201Two 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 | PTL201 |
| Placebo Oral CapsulePlacebo seamless gelatin matrix green beads containing excipients only | Drug | Placebo |
Primary outcome
Incidence of study treatment-related adverse events (AE)
Time frame: 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
Time frame: during the 4 weeks (28 days) placebo-controlled treatment period
10 secondary outcomes
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
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)
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)
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)
Sleep disturbance assessment
Time frame: at baseline (day 1) end of responder phase (day 29) and end of placebo-controlled treatment phase (day 57)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTL201 in people with Multiple Sclerosis, run by PhytoTech Therapeutics, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagit Sacks (+972 3 6449599, hsacks@mmjphytotech.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of study treatment-related adverse events (AE) (time frame: 10 weeks (70 days) from beginning of treatment to end of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.