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

Phase 1

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Lu AG06466; Drug: Placebo

• Registration Number: NCT04990219
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-04
• Study Start: 2021-09-27
• Status Verified: 2023-01
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-31
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AG06466	Lu AG06466	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.
Placebo	Placebo	Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Universitätsklinikum Düsseldorf; 🇩🇪 Dusseldorf NRW, Germany

Center of Neurology, Hertie Institute for Clinical Brain Research; 🇩🇪 Tubingen, Germany

Neurostimulation Center for Movement Disorders; 🇩🇪 Mainz, Germany

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Mountain View Clinical Research; 🇺🇸 Denver, Colorado, United States

Wake Research - Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States