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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Lu AG06466; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf NRW, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Mainz, Germany, 55131
    • Neurostimulation Center for Movement Disorders
  • Tubingen, Germany, 72076
    • Center of Neurology, Hertie Institute for Clinical Brain Research
• United States
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Wake Research - Clinical Research Center of Nevada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lu AG06466; Lu AG06466 - capsule
Placebo Comparator: Placebo; Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5.	Drug: Placebo; Placebo - capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): April 8, 2023
• Study Completion (Anticipated): April 22, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 19366A; 2021-001230-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No