Phase 4
N=121
A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients
Multiple Sclerosis · Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01964547 ↗Enrolled (actual)
121
Serious AEs
4.1%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score. — 6.8; 6.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sativex (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score. |
6.8; 6.8 | — |
| SECONDARY Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score. |
-3.1; -2.4 | — |
| SECONDARY Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. |
2; 0; 16; 6; 24; 15 | 0.0001 sig |
| SECONDARY Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. |
1; 0; 12; 6; 14; 10 | 0.0142 sig |
| SECONDARY Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. |
0; 1; 15; 6; 26; 15 | 0.0019 sig |
| SECONDARY Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score. |
-10.6; -7.7 | 0.212 |
| SECONDARY Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional. |
-0.6; -0.4 | — |
| SECONDARY The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. |
0; 2; 0; 1; 0; 1 | — |
| SECONDARY Change From Baseline to End of Treatment in Timed 10-meter Walk Times. |
6.2; 3.0 | 0.556 |
| SECONDARY Incidence of Adverse Events as a Measure of Patient Safety. |
39; 19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01964547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.