SpasticityPhase 3NCT01868048
Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.
A Phase 3 study testing Sativex in people with Spasticity and Multiple Sclerosis, run by GW Research Ltd.
Trial summary
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Multiple Sclerosis
- What is being tested?
- Sativex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2017
- 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
- Willing and able to give written informed consent.
- The subject is at least 18 years of age or older.
- Diagnosed with any disease sub-type of multiple sclerosis of at least six months duration.
- Spasticity due to multiple sclerosis of at least six months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
- Subject must be receiving at least one of the following anti-spasticity therapies to be eligible: Baclofen, Tizanidine, Clonazepam, Diazepam, Dantrolene.
- Subject is willing to maintain anti-spasticity medication at a stable dose for the duration of the study and should be stable for 30 days prior to screening.
- If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
Who cannot join
- Has previously used Nabiximols or Sativex.
- The subject is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
- Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- In the opinion of the Investigator, any known or suspected history of a substance abuse disorder (including opiate abuse), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug that should exclude the subject from participation.
- Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year).
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
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- Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically significant arrhythmia or myocardial infarction.
- Has significantly impaired renal function as evidenced by a creatinine clearance lower than 50mL/min at Visit 1.
- Has significantly impaired hepatic function at Visit 1 (Alanine Aminotransferase >5 times upper limit of normal (ULN) or bilirubin (TBL) > 2 times ULN). If the Alanine Aminotransferase or Aspartate Aminotransferase >3 times ULN and the TBL >2 times ULN (or International Normalized Ratio >1.5), this subject should not enter the study.
- Female subject of child-bearing potential and male subject whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception or complete abstinence, for example, oral contraception, double barrier or intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
- Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Subjects who have received a non-approved investigational medicinal product within 30 days of Visit 1.
- Any other significant disease or disorder which, in the opinion of the investigator or sponsor, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
- Travel outside the country of residence planned during the study.
- Subjects previously enrolled into this study.
About this study
Official title: A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis.
- Conditions
- Spasticity, Multiple Sclerosis
- Being tested
- Sativex, Placebo
- Keywords
- Spasticity, Multiple Sclerosis
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called GW-1000-02, Nabiximols, THC/CBD spray
Contains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring.
Subjects receive study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.
PlaceboDrug
Also called GA0034
Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day.
| Study group | Role | What they receive |
|---|---|---|
| Sativex | Experimental | Contains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring.
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg. Receives: Drug: Sativex |
| Placebo | Placebo comparator | Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Impression of Change (PGIC) questionnaire
Measured: This is completed by the physician at each visit whilst using the study medication.
Change in mean Modified Ashworth Scale score from baseline to the end of treatment period.
All 20 muscle groups were assessed for spasticity (using a 0-4 scale): 0= no increase in muscle tone to 4=considerable increase in muscle tone, passive movement is difficult. The score for all 20 muscle groups were added to give a total score out of 80. A decrease in score indicates an improvement in condition.
Measured: The Modified Ashworth Scale will be performed at each visit of the study
Secondary outcomes (4)
Change in mean sleep disruption (0-10 NRS) score from baseline to the end of treatment (Part B)
Measured: Recorded using IVRS daily diary every day
Change in mean spasm frequency (number of spasms per day) from baseline to the end of treatment (Part B).
Measured: Recorded using the IVRS daily day every day
Subject global impression of change (SGIC) questionnaire
At Visit 2 (i.e. prior to commencing any treatment) subjects were asked to write a brief description of their spasticity caused by multiple sclerosis and how it affected them emotionally, physically and their ability to function with day to day activities. If subjects were unable to write due to disability then the investigator staff could assist as necessary. Prior to answering the Subject global impression of change, subjects were given the description of their spasticity to aid their memory regarding their symptoms at the start of the study. They were then be asked to complete the global impression of change by answering the following question to be rated on a seven-point scale, "Please assess the change in your spasticity due to multiple sclerosis since immediately before receiving the first course of study treatment (Visit 2) using the scale below" with this anchors: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.
Measured: To be completed by the patient at every visit during treatment
Carer Global Impression of Change Questionnaire
Measured: To be completed by the carer at every visit during the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GW Research Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868048
- Sponsor's protocol ID
- GWMS1315
- Status last verified
- Aug 2016
- First submitted
- 30 May 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01868048
- Acronym / sponsor ID
- GWMS1315
- Conditions
- Spasticity, Multiple Sclerosis
- Keywords
- Spasticity, Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GW Research LtdIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2017 (estimated)
- First posted
- 4 Jun 2013 (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.
The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativex | Experimental | Drug: SativexContains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg. |
| Placebo | Placebo comparator | Drug: PlaceboOromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent.
- The subject is at least 18 years of age or older.
- Diagnosed with any disease sub-type of multiple sclerosis of at least six months duration.
- Spasticity due to multiple sclerosis of at least six months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
- Subject must be receiving at least one of the following anti-spasticity therapies to be eligible: Baclofen, Tizanidine, Clonazepam, Diazepam, Dantrolene.
Key exclusion criteria (15 listed)
- Has previously used Nabiximols or Sativex.
- The subject is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
- Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- In the opinion of the Investigator, any known or suspected history of a substance abuse disorder (including opiate abuse), current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non prescribed use of any prescription drug that should exclude the subject from participation.
- Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year).
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 |
|---|---|---|
| SativexAlso: GW-1000-02, Nabiximols, THC/CBD sprayContains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Subjects receive study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg. | Drug | Sativex |
| PlaceboAlso: GA0034Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day. | Drug | Placebo |
Primary outcome
Physician Global Impression of Change (PGIC) questionnaire
Time frame: This is completed by the physician at each visit whilst using the study medication.
Change in mean Modified Ashworth Scale score from baseline to the end of treatment period.
Time frame: The Modified Ashworth Scale will be performed at each visit of the study
All 20 muscle groups were assessed for spasticity (using a 0-4 scale): 0= no increase in muscle tone to 4=considerable increase in muscle tone, passive movement is difficult. The score for all 20 muscle groups were added to give a total score out of 80. A decrease in score indicates an improvement in condition.
4 secondary outcomes
Change in mean sleep disruption (0-10 NRS) score from baseline to the end of treatment (Part B)
Time frame: Recorded using IVRS daily diary every day
Change in mean spasm frequency (number of spasms per day) from baseline to the end of treatment (Part B).
Time frame: Recorded using the IVRS daily day every day
Subject global impression of change (SGIC) questionnaire
Time frame: To be completed by the patient at every visit during treatment
Carer Global Impression of Change Questionnaire
Time frame: To be completed by the carer at every visit during the treatment period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sativex in people with Spasticity and Multiple Sclerosis, run by GW Research Ltd.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Physician Global Impression of Change (PGIC) questionnaire (time frame: This is completed by the physician at each visit whilst using the study medication.). 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 11 Aug 2016; AzTrials last refreshed its copy on 29 Oct 2026.