Multiple Sclerosis
Conditions
Brief summary
The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).
Detailed description
The participants will be randomized to Lu AG06466 or placebo in a 2:1 ratio.
Interventions
DRUGLu AG06466
Lu AG06466 - capsule
DRUGPlacebo
Placebo - capsule
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The participant has a diagnosis of MS, as per the 2017 McDonald criteria. * The participant has clinically stable MS (such as no relapse and/or stable Expanded Disability Status Scale \[EDSS\] or alternative clinical assessment score) for at least 6 months prior to screening. * The participant has ongoing spasticity for at least 90 days prior to screening. * The participant is on a stable regimen for at least 30 days prior to screening for all medications and non pharmacological therapies, including therapies that are intended to alleviate spasticity (for example, oral baclofen, tizanidine, dalfampridine), and willing to remain on the same regimen throughout the duration of the study. * The participant reports walking impairment due to lower limb spasticity. Key
Exclusion criteria
* The participant has any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity or the participant's overall ability to participate in the study. * The participant has ambulation difficulties due to any concomitant disease or disorder other than MS. * The participant has any known or suspected hypersensitivity to cannabinoids (CBs) or any of the excipients of the investigational medicinal product (IMP). * The participant has a positive drug screening test, except for non-CB medications used to treat a medical condition and reported as such by the participant; the participant has a positive drug screen test for cannabis/delta-9-tetrahydrocannabinol. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Spasticity Response | Baseline to Week 5 | Spasticity response defined as ≥30% increase from baseline in spasticity Numerical Rating Scale (NRS) score |
| Change from Baseline to Week 5 in Spasticity NRS Score | Baseline, Week 5 | — |
Countries
Germany, United States
Outcome results
None listed