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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

NCT00488839

Multiple Sclerosis

COMPLETED PHASE3

Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition

NCT02859792

Spinal Cord Injury

UNKNOWN PHASE2

A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)

NCT06673056

Ataxia-Telangiectasia Ataxia-Telangiectasia (A-T)

ACTIVE_NOT_RECRUITING PHASE3

Study of SPARC1103 in Subjects With Spasticity

NCT02027025

Spasticity

COMPLETED PHASE2

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

NCT04815967

Spasticity Cerebrovascular Accident Multiple Sclerosis +3 more

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

Lu AG06466 - capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo - capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lu AG06466

Lu AG06466 - capsule

Intervention Type DRUG

Placebo

Placebo - capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No