Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity
NCT ID: NCT01538225
Last Updated: 2014-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2012-04-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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first sativex, second placebo
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)
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
Placebo
Placebo
Same frequency and dosage form as Sativex.
Duration: 2 weeks
first placebo, second sativex
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)
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
Placebo
Placebo
Same frequency and dosage form as Sativex.
Duration: 2 weeks
Interventions
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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
Placebo
Placebo
Same frequency and dosage form as Sativex.
Duration: 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Giancarlo Comi, Prof
Role: PRINCIPAL_INVESTIGATOR
Institute of Experimental Neurology (Milan, Italy)
Locations
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Institute of Experimental Neurology
Milan, , Italy
Countries
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Other Identifiers
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2011-002258-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M/SATIVX/01
Identifier Type: -
Identifier Source: org_study_id
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