Clinical trial NCT01964547: A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients
Official title: A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Spasticity
Keywords: Cognition
Mood
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.

Detailed description: Eligible patients entered this 50 week multicenter, double-blind, randomised, placebo-controlled, parallel group study which evaluated the effect of Sativex on cognitive performance. At each scheduled clinic visit, patients were assessed for cognitive performance, mood, severity of spasticity, use of investigational medicinal products and number of visits to a healthcare professional. Primary efficacy comparisons were made between scores recorded during baseline and scores recorded at the end of treatment.

Eligibility criteria: Inclusion Criteria (ALL to be fulfilled):

* Patient is willing and able to give informed consent for participation in the study.
* Patient is aged 18 years or above.
* Diagnosed with any disease sub-type of multiple sclerosis.
* Diagnosed with symptomatic spasticity due to multiple sclerosis.
* Patient has at least moderate spasticity in the opinion of the investigator.
* Patient fulfils at least one of the two criteria below. Subject must be either:

  * Currently established on a regular dose of anti-spasticity therapy, or
  * Previously tried and failed anti-spasticity therapy.
* Stable medication regimen for at least four weeks prior to study entry, for all medications which may have an effect on spasticity and/or cognition.
* If the patient is taking disease modifying medication this must be at a stable dose for three months prior to the initial visit.
* Willing and able to comply with all study requirements.
* Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable.
* Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria (if ANY apply):

* Any history or immediate family of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
* Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures) that may influence the patient's level of cognition or mood.
* Currently using or has used cannabis or cannabinoid-based medications within 30 days of study entry and unwilling to abstain for the duration of the study.
* Any known or suspected history of a diagnosed dependence disorder, 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.
* Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
* Female patients of child bearing potential and male subjects 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 patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
* Patients who have received an investigational medicinal product within the 12 weeks prior to the initial visit.
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study may influence the result of the study, or the patient's ability to participate in the study.
* Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
* Previously randomised to this study.

Primary outcomes:
measure: Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.
timeFrame: 0-48 weeks
Secondary outcomes:
measure: Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.
timeFrame: 0-48 weeks
measure: Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
timeFrame: 0-48 weeks
measure: Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
timeFrame: 0-48 weeks
measure: Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
timeFrame: 0-48 weeks
measure: Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.
timeFrame: 0-48 weeks
measure: Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.
timeFrame: 0-48 weeks
measure: The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
timeFrame: 0-48 weeks
measure: Change From Baseline to End of Treatment in Timed 10-meter Walk Times.
timeFrame: 0-48 weeks
measure: Incidence of Adverse Events as a Measure of Patient Safety.
timeFrame: 0-50 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: MS Centre, Charles University
Study officials:
References:
citation: Abstracts of ECTRIMS (Congress of the European Committee for Treatment and Research in Multiple Sclerosis) 2013. October 2-5, 2013. Copenhagen, Denmark. Mult Scler. 2013 Oct;19(11 Suppl):8-597. No abstract available.
citation: Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.