A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis

Study Overview
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Brief Summary
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The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).

Detailed Description
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The participants will be randomized to Lu AG06466 or placebo in a 2:1 ratio.

Official Title
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Interventional, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Lu AG06466
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG06466<br>Participants will receive Lu AG06466 at a starting dose orally once daily for 4 days (Day 1 to Day 4), followed by Lu AG06466 at a higher titrated dose orally once daily for 4 days (Day 5 to Day 8), followed by Lu AG06466 at a higher titrated treatment dose orally once daily from Day 9 until Day 35/Week 5. | Drug: Lu AG06466<br>* Lu AG06466 - capsule<br>|
| Placebo Comparator: Placebo<br>Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5. | Drug: Placebo<br>* Placebo - capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Spasticity Response | Spasticity response defined as ≥30% increase from baseline in spasticity Numerical Rating Scale (NRS) score | Baseline to Week 5 | 
| Change from Baseline to Week 5 in Spasticity NRS Score |  | Baseline, Week 5 |