Multiple SclerosisPhase 3NS-MSSNCT01538225
Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity
A Phase 3 study testing Sativex® in people with Multiple Sclerosis, run by Almirall, S.A. at 1 site in Italy.
Trial summary
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Sativex®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Nov 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above
- Willing and able to comply with the protocol for the duration of the study
- Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months
- Relapse free from at least 3 months before screening visit
- Lower limb spasticity
- EDSS from > 3.0 and < 6.5
Show all 10Show fewer
- Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment
- Immunomodulatory or immunosuppressant therapies not modified during the study and 6 months before starting the study
- Stable doses of anti-spasticity agents from at least 2 months prior to screening visit
- Have given written informed consent
Who cannot join
- Any concomitant disease that may cause spasticity or that could interfere with subject's spasticity
- Botulinum Toxin injection for spasticity in the 4 months prior to screening visit
- Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids
- Significant cardiac, renal or hepatic disease
- Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study
- Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter
- Sativex® SmPC contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).
- Conditions
- Multiple Sclerosis
- Being tested
- Sativex®, Placebo
- Keywords
- Spasticity
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sativex®Drug
THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients.
Duration: 2 weeks
PlaceboDrug
Placebo
Same frequency and dosage form as Sativex.
Duration: 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| first sativex, second placebo | Experimental | 2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo) Receives: Drug: Sativex®; Drug: Placebo |
| first placebo, second sativex | Experimental | 2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex) Receives: Drug: Sativex®; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
H/M reflex ratio
To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
Measured: week 0, 4
Secondary outcomes (5)
Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb
Neurophysiology
- H/M ratio: To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at weeks 6 and 10
- Transcranial Magnetic Stimulation
- Motor threshold to obtain MEPs to the upper limb (time 0-4; 6-10 weeks);
- MEPs amplitudes at 15% above motor threshold, measured as MEP/M ratio to APB (abductor pollicis brevis) and abductor of hallucis, in which M is the compound muscle potential in response to peripheral stimulation (time 0-4; 6-10 weeks);
- Intracortical facilitation/inhibition (ICI/ICF) to the upper limb (time 0-4; 6-10 weeks);
Measured: week 0, 4, 6 and 10
Adverse Events recording
Measured: week 0, 4, 6 and 10
Spasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)
Mean spasticity score recorded using a 0-10 11-point numerical spasticity rating scale (NRS) at baseline (pre-treatment) and week 4, 6 and 10
- Mean modified Ashworth (MAS) score at baseline (pre-treatment), week 4, 6, 10
Measured: week 0, 4, 6, 10
Function: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT
Function:
- Mean Timed 25 feet and 10 meters walk recorded at baseline (pre-treatment) and week 4, 6, 10
- Mean Hand dexterity measured with 9-HPT recorded at baseline (pre-treatment) and week 4, 6, 10
Measured: week 0, 4, 6, 10
Other MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)
Other MS Symptoms:
- Mean Sleep Quality NRS recorded at baseline (pre-treatment) and week 4, 6, 10
- Pain NRS and Spasm frequency recorded at baseline (pre-treatment) and week 4, 6, 10
- Fatigue measured with the Fatigue Severity Scale (FSS) recorded at baseline (pre-treatment) and week 4, 6, 10
Measured: week 0, 4, 6, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionNov 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giancarlo Comi, Prof, Principal investigator, Institute of Experimental Neurology (Milan, Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538225
- Sponsor's protocol ID
- M/SATIVX/01
- Other IDs
- 2011-002258-30
- Acronym
- NS-MSS
- Status last verified
- Jan 2014
- First submitted
- 20 Feb 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01538225
- Acronym / sponsor ID
- NS-MSS / M/SATIVX/01
- Conditions
- Multiple Sclerosis
- Keywords
- Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Feb 2012 (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.
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first sativex, second placebo | Experimental | Drug: Sativex®, Drug: Placebo2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo) |
| first placebo, second sativex | Experimental | Drug: Sativex®, Drug: Placebo2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or above
- Willing and able to comply with the protocol for the duration of the study
- Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months
- Relapse free from at least 3 months before screening visit
- Lower limb spasticity
Key exclusion criteria (7 listed)
- Any concomitant disease that may cause spasticity or that could interfere with subject's spasticity
- Botulinum Toxin injection for spasticity in the 4 months prior to screening visit
- Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids
- Significant cardiac, renal or hepatic disease
- Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study
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 |
|---|---|---|
| Sativex®THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients. Duration: 2 weeks | Drug | first placebo, second sativex, first sativex, second placebo |
| PlaceboPlacebo Same frequency and dosage form as Sativex. Duration: 2 weeks | Drug | first placebo, second sativex, first sativex, second placebo |
Primary outcome
H/M reflex ratio
Time frame: week 0, 4
To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
5 secondary outcomes
Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb
Time frame: week 0, 4, 6 and 10
Adverse Events recording
Time frame: week 0, 4, 6 and 10
Spasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)
Time frame: week 0, 4, 6, 10
Function: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT
Time frame: week 0, 4, 6, 10
Other MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)
Time frame: week 0, 4, 6, 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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.
Giancarlo Comi, Prof principal investigator
Institute of Experimental Neurology (Milan, Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sativex® in people with Multiple Sclerosis, run by Almirall, S.A. at 1 site in Italy.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jan 2014. 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 Italy. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H/M reflex ratio (time frame: week 0, 4). 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 20 Jan 2014.