Cerebral PalsyPhase 3NCT01898520
A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years
A Phase 3 study testing Sativex in people with Cerebral Palsy, run by Jazz Pharmaceuticals at 14 sites in 3 countries.
Trial summary
A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Sativex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Dec 2013to Mar 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females aged between 8 and 18 years suffering from cerebral palsy or traumatic central nervous system injury.
- Participant and/or authorised representative willing and able to give informed consent for participation in the study.
- To have been under treatment for their spasticity for at least one year and to have reached a stage of non-progressive spasticity.
- Participant able (in the investigators opinion) and willing to comply with all study requirements.
- Participant has received inadequate efficacy and/or experienced unacceptable side effects from previous or current treatment with at least one of the following medications for spasticity:
- Baclofen, Diazepam (or another benzodiazepine), Dantrolene, Tizanidine, Gabapentin, Trihexyphenidyl.
Show all 10Show fewer
- Gross Motor Function Classification Scale Level III - V.
- MAS of two or higher in at least one muscle group.
- Participant and/or authorised representative willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
- Participant and/or authorised representative willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Any known or suspected history of:
- Schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative.
- Alcohol or substance abuse.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s)
- Use of cannabis or cannabinoid based medications (including within 30 days or 60 days of study entry respectively).
- Weight less than 15 kg.
Show all 18Show fewer
- Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Participants who have received an Investigational Medicinal Product (IMP) within the 12 weeks prior to the screening visit.
- Has been treated with botulinum toxin in the previous 12 weeks.
- Concomitant use of botulinum toxin
- Any other significant disease or disorder, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant's ability to participate in the study.
- Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study.
- Significant cardiac, renal or hepatic disease.
- Planned surgical procedure during the randomised phase of the study.
- Travel outside the country of residence planned during the study.
- Participants previously randomised into this study.
- Unwilling to abstain from donation of blood during the study
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United Kingdom11 sites
Center 2
Bristol
Center 6
Cambridge
Center 10
Exeter
Center 13
Glasgow
Center 3
Liverpool
Center 1
London
Center 5
London
Center 12
Norwich
Center 9
Nottingham
Center 11
Salisbury
Center 4
Sheffield
About this study
Official title: The Efficacy, Safety and Tolerability of Sativex as an Adjunctive Treatment to Existing Anti-spasticity Medications in Children Aged 8 to 18 Years With Spasticity Due to Cerebral Palsy or Traumatic Central Nervous System Injury Who Have Not Responded Adequately to Their Existing Anti-spasticity Medications: a Parallel Group Randomised, Double-blind, Placebo-controlled Study Followed by a 24-week Open Label Extension Phase
A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.
Read the detailed description
A 12 week randomised, double-blind, placebo-controlled,parallel group study followed by a 24-week open-label extension phase.
The primary objective is to assess the efficacy of Sativex treatment using a spasticity 0-10 numerical rating scale (NRS). The endpoint for analysis is the comparison between Sativex and placebo in the change from baseline to the end of the acute phase in mean spasticity 0-10 NRS scores (week 12 or last seven days prior to withdrawal).
The secondary objectives are to assess the safety and tolerability of Sativex via volunteered adverse events, laboratory parameters and vital signs. The efficacy of Sativex compared to placebo is also investigated for the following outcomes: spasticity (modified tardieu scale (MTS) score of the most affected limb and the modified ashworth scale (MAS) score of the main muscle groups of the upper and lower limb), sleep quality (sleep 0-10 NRS), pain (paediatric pain profile [PPP]), quality of life (of both the participant and the caregiver; cerebral palsy quality of life (QOL) questionnaire and caregiver QOL questionnaire), comfort (comfort questionnaire), depression assessment (childrens depression inventory (CDI 2)) and the caregiver's global impression of change (CGIC).
- Conditions
- Cerebral Palsy
- Being tested
- Sativex, Placebo
- Keywords
- Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called Nabiximols, THC:CBD spray, GW-1000-02
Oromucosal spray containing THC (27 mg/mL):CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12.
PlaceboDrug
Also called GW-4000-01
Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day.
| Study group | Role | What they receive |
|---|---|---|
| Sativex | Active comparator | Oromucosal spray containing delta-9-tetrahydrocannabinol (THC) (27 mg/mL):cannabidiol (CBD) (25 mg/mL). Each 100 μL spray to the sub-lingual or oral mucosa delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12. Receives: Drug: Sativex |
| Placebo | Placebo comparator | Oromucosal spray containing ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum number of daily sprays was 12. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score
The spasticity 0-10 NRS was completed daily at bedtime using a paper study diary. The difference between spasticity and spasm was clearly explained to the caregiver. The primary caregiver was asked the following question: "This question is about your child's muscles and how soft or tight/hard they have felt today. Think carefully about how your child's muscles have felt today and circle a number from 0 to 10 that best describes this, where: 0 = 'my child's muscles have felt totally relaxed' and 10 = 'my child's muscles have felt the tightest/hardest they have ever felt'". A reduction in score indicates an improvement in condition.
The mean spasticity 0-10 NRS score of the last 7 days of the baseline period was used for a patient's mean baseline score. The mean 0-10 NRS score of the last 7 days prior to completion/withdrawal was used for a patient's mean end of treatment score.
Measured: Day 0 - Day 84
Secondary outcomes (11)
Change from baseline to the end of 12 weeks' treatment in mean MTS score of the most affected limb
This study looked at the MTS in the worst affected limb only. The same limb was assessed at each visit, preferably also by the same examiner.
The MTS used the following criteria:
- Individuals were positioned in the sitting position to test the upper extremities and a supine position to test the lower extremities
- Three speed definitions:
- V1 is slow as possible
- V2 speed of limb falling under gravity
- V3 moving as fast as possible
- The MTS describes R1 and R2. R1 is the angle of muscle reaction; R2 is the full passive range of movement.
- R2 is measured at V1 and R1 at V3. R2-R1 = dynamic tone component of the muscle. The relationship between R1 and R2 estimates the relative contributions of spasticity compared to contracture.
A reduction in score indicates and improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean MAS score of the main muscle groups of the upper and lower limb
Participants were tested in the supine position and participants were instructed to relax. Muscle groups in the ankle, knee, hip, shoulder, elbow and wrist were rated on a scale of 0 = No increase in muscle tone, 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM), 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 = Considerable increase in muscle tone, passive movement difficult, 4 = Affected part(s) rigid in flexion or extension. The MAS was performed by the same examiner at each visit, where possible. A reduction in score indicates an improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean sleep quality 0-10 NRS score
The sleep quality 0-10 NRS was completed at the same time each day, ideally when waking in the morning. This questionnaire was designed to record the level of sleep disturbance. The primary caregiver was asked the following question: "This question is about how badly your child slept last night. Please mark a number from 0 to 10 that indicates how bad your child's sleep was where: 0 = My child had a night of non-stop sleep and 10 = My child was unable to sleep at all". A reduction in score indicates and improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean Paediatric Pain Profile (PPP) score
The PPP is a 20-item behaviour rating scale designed to assess pain in children with severe neurological disability. Each item is scored on a four point scale of 0 to 3 as occurring 'not at all' (zero) to 'a great deal' (three) in the given time period. The total score therefore will range from 0 to 60. The questionnaire was designed to be completed by the child's primary caregiver and was completed at each assessment visit during the study. A reduction in score indicates an improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean cerebral palsy QOL score
The cerebral palsy QOL-Child QoL questionnaire (aged 4-12 years) is a 66-item questionnaire that looks at eight important domains of life including friends and family; participation; communication; health; special equipment; pain and bother; access to services; and parents' health. Completed by the primary caregiver it assesses how the caregiver thinks the child feels about these aspects of their life. The numbers range from one (very unhappy) to nine (very happy).
The teen questionnaire (aged 13-18 years) comes with two questionnaires, one to be completed by the participant, if applicable, and one by the primary caregiver. The first seven sections of the questionnaire are identical and look at seven important domains of life including friends and family; school; participation; communication; health, special equipment and pain and bother. The caregiver questionnaire has an additional section which looks at access to services.
Increases in score indicate an improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean comfort questionnaire outcome (time spent sitting in comfort)
The comfort questionnaire was completed at the same time each day, i.e. bedtime in the evening. The caregiver was asked to reflect on the whole day and record the longest number of minutes at any one time over which their child was able to sit in comfort for, without moving position. An increase in time indicates an improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean CDI 2 score
The CDI 2 contains 28 items, each of which consists of three statements (each scored 0-2 [0=best outcome, 2=worst outcome]). For each item, the participant is asked to select the statement that best describes his or her feelings. The assessment is designed for a variety of situations, including schools, child guidance clinics, pediatric practices, and child psychiatric settings. If the participant is unable to complete the questionnaire, the questionnaire will be left blank.
A reduction in score indicates an improvement in condition.
Measured: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean caregiver QOL (SF-36-II) score
The SF-36-II is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (two items) role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy/vitality (four items), pain (two items), and general health perception (five items). There is a further unscaled single item asking respondents about health change over the past year. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state). An increase in score indicates an improvement in condition.
Measured: Day 0 - Day 84
CGIC response on participants general functional capabilities at the end of 12 weeks' treatment
The main caregiver was asked to assess the change in the participant's condition. Questions were rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The caregiver was asked:
"How have the participant's general functional abilities changed since Visit 2?" (i.e. change from baseline).
The number of participants for each marker is presented.
Measured: Day 84
CGIC response on participants ease of transfer at the end of 12 weeks' treatment
The main caregiver was asked to assess the change in the participant's condition. Questions were rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The caregiver was asked:
"How has the participant's ease of transfer changed since Visit 2?"(i.e. change from baseline).
The number of participants for each marker is presented.
Measured: Day 84
The incidence of adverse events during the randomised treatment period
The number of participants who reported an adverse event during the randomised treatment part of the study is presented.
Measured: Day 0 - Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898520
- Sponsor's protocol ID
- GWSP08258
- Status last verified
- Dec 2022
- First submitted
- 10 Jul 2013
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Safety and Tolerability of Sativex as an Adjunctive Treatment to Existing Anti-spasticity Medications in Children Aged 8 to 18 Years With Spasticity Due to Cerebral Palsy or Traumatic Central Nervous System Injury Who Have Not Responded Adequately to Their Existing Anti-spasticity Medications: a Parallel Group Randomised, Double-blind, Placebo-controlled Study Followed by a 24-week Open Label Extension Phase
- ClinicalTrials.gov ID
- NCT01898520
- Acronym / sponsor ID
- GWSP08258
- Conditions
- Cerebral Palsy
- Keywords
- Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Jul 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.
A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.
Detailed description
A 12 week randomised, double-blind, placebo-controlled,parallel group study followed by a 24-week open-label extension phase.
The primary objective is to assess the efficacy of Sativex treatment using a spasticity 0-10 numerical rating scale (NRS). The endpoint for analysis is the comparison between Sativex and placebo in the change from baseline to the end of the acute phase in mean spasticity 0-10 NRS scores (week 12 or last seven days prior to withdrawal).
The secondary objectives are to assess the safety and tolerability of Sativex via volunteered adverse events, laboratory parameters and vital signs. The efficacy of Sativex compared to placebo is also investigated for the following outcomes: spasticity (modified tardieu scale (MTS) score of the most affected limb and the modified ashworth scale (MAS) score of the main muscle groups of the upper and lower limb), sleep quality (sleep 0-10 NRS), pain (paediatric pain profile [PPP]), quality of life (of both the participant and the caregiver; cerebral palsy quality of life (QOL) questionnaire and caregiver QOL questionnaire), comfort (comfort questionnaire), depression assessment (childrens depression inventory (CDI 2)) and the caregiver's global impression of change (CGIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativex | Active comparator | Drug: SativexOromucosal spray containing delta-9-tetrahydrocannabinol (THC) (27 mg/mL):cannabidiol (CBD) (25 mg/mL). Each 100 μL spray to the sub-lingual or oral mucosa delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12. |
| Placebo | Placebo comparator | Drug: PlaceboOromucosal spray containing ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum number of daily sprays was 12. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Males and females aged between 8 and 18 years suffering from cerebral palsy or traumatic central nervous system injury.
- Participant and/or authorised representative willing and able to give informed consent for participation in the study.
- To have been under treatment for their spasticity for at least one year and to have reached a stage of non-progressive spasticity.
- Participant able (in the investigators opinion) and willing to comply with all study requirements.
- Participant has received inadequate efficacy and/or experienced unacceptable side effects from previous or current treatment with at least one of the following medications for spasticity:
Key exclusion criteria (18 listed)
- Any known or suspected history of:
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s)
- Use of cannabis or cannabinoid based medications (including within 30 days or 60 days of study entry respectively).
- Weight less than 15 kg.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
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: Nabiximols, THC:CBD spray, GW-1000-02Oromucosal spray containing THC (27 mg/mL):CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12. | Drug | Sativex |
| PlaceboAlso: GW-4000-01Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day. | Drug | Placebo |
Primary outcome
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score
Time frame: Day 0 - Day 84
The spasticity 0-10 NRS was completed daily at bedtime using a paper study diary. The difference between spasticity and spasm was clearly explained to the caregiver. The primary caregiver was asked the following question: "This question is about your child's muscles and how soft or tight/hard they have felt today. Think carefully about how your child's muscles have felt today and circle a number from 0 to 10 that best describes this, where: 0 = 'my child's muscles have felt totally relaxed' and 10 = 'my child's muscles have felt the tightest/hardest they have ever felt'". A reduction in score indicates an improvement in condition. The mean spasticity 0-10 NRS score of the last 7 days of the baseline period was used for a patient's mean baseline score. The mean 0-10 NRS score of the last 7 days prior to completion/withdrawal was used for a patient's mean end of treatment score.
11 secondary outcomes
Change from baseline to the end of 12 weeks' treatment in mean MTS score of the most affected limb
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean MAS score of the main muscle groups of the upper and lower limb
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean sleep quality 0-10 NRS score
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean Paediatric Pain Profile (PPP) score
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean cerebral palsy QOL score
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean comfort questionnaire outcome (time spent sitting in comfort)
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean CDI 2 score
Time frame: Day 0 - Day 84
Change from baseline to the end of 12 weeks' treatment in mean caregiver QOL (SF-36-II) score
Time frame: Day 0 - Day 84
CGIC response on participants general functional capabilities at the end of 12 weeks' treatment
Time frame: Day 84
CGIC response on participants ease of transfer at the end of 12 weeks' treatment
Time frame: Day 84
The incidence of adverse events during the randomised treatment period
Time frame: Day 0 - Day 84
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 Dec 2022.
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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.
14 sites in 3 countries: 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 Cerebral Palsy, run by Jazz Pharmaceuticals at 14 sites in 3 countries.
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 18 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Israel, Czechia. 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 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?
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score (time frame: Day 0 - Day 84). 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 Dec 2022.