SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICSTHE S A V A N T TRIAL - SAVANT

Almirall Hermal GmbH0 sites228 target enrollmentDecember 22, 2015

ConditionsModerate to severe spasticity due to MS (multiple sclerosis).MedDRA version: 19.0Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 100000004852 Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsSATIVEX

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe spasticity due to MS (multiple sclerosis).
Sponsor: Almirall Hermal GmbH
Enrollment: 228
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 22, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Almirall Hermal GmbH

Eligibility Criteria

Inclusion Criteria

•1\.Male or female patients of at least 18 years of age.
•2\.Diagnosis of MS (any form) for at least 12 months.
•3\.If the patient is taking disease modifying medication or antispastic drugs other than oral baclofen, tizanidine or dantrolene, this must be at a stable dose for 3 months prior to the screening visit.
•4\.Moderate to severe spasticity, defined as a score of 4 or more on the MS spasticity 0\-10 NRS scale as scored by the patient at the screening visit (considering the previous week), despite optimized previous and current treatment.
•5\.Existing MS spasticity symptoms for at least 12 months.
•6\.Eligible for treatment with Sativex according to the current SPC.
•7\.Previous treatment with at least 2 different optimized oral MS spasticity therapies before inclusion, which must include at least 1 of oral baclofen or oral tizanidine (mono\- or combination therapy).
•8\.Currently receiving optimized treatment with at least 1 oral antispastic drug (baclofen and/or tizanidine and/or dantrolene as mono\- or combination therapy), that has been stable for at least 3 months prior to the screening visit. Despite optimization, the patient does not have adequate relief of spasticity symptoms. Optimization is defined as having reached the most efficacious and best tolerated dose according to the relevant SPCs. The treating physician and the patient must confirm that the current treatment has been optimized.
•9\.Able (physical ability or supportive person) to comply with the study preparations correctly and to follow the study procedure and restrictions.
•10\.Written informed consent.

Exclusion Criteria

•1\.Contraindication to treatment with Sativex (according to the SPC).
•2\.Previous administration of Sativex.
•3\.Current consumption of cannabis herb or taking other cannabinoid\-based drugs within 30 days prior to study entry, and/or unwillingness to avoid consumption over the study period.
•4\.Treatment with botulinum toxin injection for the relief of spasticity from within 6 months prior to the screening visit.
•5\.Any medical history or family history of schizophrenia, other psychotic disorders, severe personality disorder or other significant psychiatric disorder other than depression, which is associated with the underlying disease MS.
•6\.Current use of illegal drugs, non\-prescribed, or off\-label prescription drugs. A qualitative urine test for TCH will be performed at screening and after wash\-out.
•7\.Any known or suspected history of a dependence disorder or current heavy alcohol consumption in the opinion of the investigator, and according to local guidelines.
•8\.Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the involved IMPs.
•9\.Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures) that may influence the patient’s level of cognition or mood.
•10\.Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter. A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least 1 year post\-menopausal or has undergone tubal ligation.