Multiple SclerosisPhase 3NCT01606137
A Study of the Long-term Safety of Sativex Use
A Phase 3 study testing GW-1000-02 in people with Multiple Sclerosis and Spasticity, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
Trial summary
Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Spasticity, Pain
- What is being tested?
- GW-1000-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2002to Dec 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 informed consent.
- Male or female aged 18 years or above.
- Diagnosed with a condition categorised as one of the following: multiple sclerosis, spinal cord conditions, peripheral nerve injury or central nervous system damage associated with vascular, traumatic, infective, genetic or metabolic disease and whose symptom(s) were not wholly relieved by currently available therapy, prior to the previous study of GW-1000-02 or placebo.
- Had participated in a GW clinical study using GW-1000-02 within the previous month.
- Had shown tolerability to the study medication during the previous GW study.
- Was expected, by the investigator, to gain clinical benefit from receiving long-term GW-1000-02.
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- Were willing, if female and of child bearing potential or male subjects with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
- Had not used cannabinoids (cannabis, Marinol or Nabilone) for at least seven days before Visit 1 (the exception being GW-1000-02 given as study medication) and were willing to abstain from any use of cannabis during the study.
- Recent (within seven days) haematology and blood chemistry that was normal or considered clinically acceptable in view of the subjects underlying condition.
- Able (in the investigators opinion) and willing to comply with all study requirements.
- Willing for the Home Office to be notified of his or her participation in the study.
- Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- History of serious psychiatric illness, including schizophrenia, other psychotic illness or severe personality disorder other than depression associated with the underlying condition.
- Known or strongly suspected of alcohol or substance abuse or considered by the investigator to have been at risk of alcohol or substance abuse.
- Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
- History of epilepsy or convulsions.
- Significant renal or hepatic impairment.
- Terminally ill.
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- Any other significant disease or disorder which, in the opinion of the investigator, may have either put the subject at risk because of participation in the study, or may have influenced the result of the study, or the subject's ability to participate in the study.
- Female subjects who were pregnant, lactating or planning pregnancy during the course of the study.
- Regular levodopa (Sinemet, Sinemet Plus, Levodopa, L-dopa, Madopar, Benserazide) therapy within seven days of study entry.
- Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
- Known or suspected adverse reaction to cannabinoids.
- Donation of blood during the study.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.
Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.
Read the detailed description
Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.
- Conditions
- Multiple Sclerosis, Spasticity, Pain
- Being tested
- GW-1000-02
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW-1000-02Drug
Also called Sativex
Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.
| Study group | Role | What they receive |
|---|---|---|
| GW-1000-02 | Experimental | Active treatment Receives: Drug: GW-1000-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events as a Measure of Subject Safety.
Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.
Measured: Up to 1051 days
Secondary outcomes (16)
Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Measured: 0 - 52 weeks
Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Measured: 0 - 52 weeks.
Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Measured: 0 - 52 weeks.
Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Measured: 0 - 52 weeks.
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Measured: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Measured: Up to 1051 days
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Measured: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Measured: Up to 1051days
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Measured: Up to 1051
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Measured: Up to 1051 days
Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Measured: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Measured: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
Measured: Up to 1051 days
Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
Measured: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Pain.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
Measured: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
Measured: Up to 1051 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startFeb 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Serpell, ChB FRCA, Principal investigator, Gartnavel General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606137
- Sponsor's protocol ID
- GWEXT0102
- Status last verified
- Apr 2023
- First submitted
- 21 May 2012
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Serpell MG, Notcutt W, Collin C. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis. J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 10.
PubMed 22878432
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open Label, Safety and Tolerability Study of Cannabis Based Medicine Extract in Patients Who Have Participated in a GW Clinical Study Using Cannabis Based Medicine.
- ClinicalTrials.gov ID
- NCT01606137
- Acronym / sponsor ID
- GWEXT0102
- Conditions
- Multiple Sclerosis, Spasticity, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.
Detailed description
Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GW-1000-02 | Experimental | Drug: GW-1000-02Active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to give informed consent.
- Male or female aged 18 years or above.
- Diagnosed with a condition categorised as one of the following: multiple sclerosis, spinal cord conditions, peripheral nerve injury or central nervous system damage associated with vascular, traumatic, infective, genetic or metabolic disease and whose symptom(s) were not wholly relieved by currently available therapy, prior to the previous study of GW-1000-02 or placebo.
- Had participated in a GW clinical study using GW-1000-02 within the previous month.
- Had shown tolerability to the study medication during the previous GW study.
Key exclusion criteria (13 listed)
- History of serious psychiatric illness, including schizophrenia, other psychotic illness or severe personality disorder other than depression associated with the underlying condition.
- Known or strongly suspected of alcohol or substance abuse or considered by the investigator to have been at risk of alcohol or substance abuse.
- Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
- History of epilepsy or convulsions.
- Significant renal or hepatic impairment.
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 |
|---|---|---|
| GW-1000-02Also: SativexContained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation. | Drug | GW-1000-02 |
Primary outcome
Incidence of Adverse Events as a Measure of Subject Safety.
Time frame: Up to 1051 days
Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.
16 secondary outcomes
Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.
Time frame: 0 - 52 weeks
Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
Time frame: 0 - 52 weeks.
Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.
Time frame: 0 - 52 weeks.
Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.
Time frame: 0 - 52 weeks.
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
Time frame: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.
Time frame: Up to 1051 days
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
Time frame: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.
Time frame: Up to 1051days
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
Time frame: Up to 1051
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.
Time frame: Up to 1051 days
Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
Time frame: Up to 1051 days
Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.
Time frame: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.
Time frame: Up to 1051 days
Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.
Time frame: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Pain.
Time frame: Up to 1051 days.
Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.
Time frame: Up to 1051 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22878432Serpell MG, Notcutt W, Collin C. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis. J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 10.
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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.
Michael Serpell, ChB FRCA principal investigator
Gartnavel General Hospital
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 GW-1000-02 in people with Multiple Sclerosis and Spasticity, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
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 13 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 6 May 2023. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Adverse Events as a Measure of Subject Safety. (time frame: Up to 1051 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606137, which also lists 1 linked publication.
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 6 May 2023.