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

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Lu AG06466

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mountain View Clinical Research
Johns Hopkins University
Washington University School of Medicine
Wake Research - Clinical Research Center of Nevada
Universitätsklinikum Düsseldorf
Neurostimulation Center for Movement Disorders
Center of Neurology, Hertie Institute for Clinical Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lu AG06466

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of Participants with Spasticity Response

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04990219

First Posted

July 29, 2021

Last Updated

February 1, 2023

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT04990219

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated for strategic reasons

Study Start Date

September 27, 2021 (Actual)

Primary Completion Date

January 19, 2023 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lu AG06466

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lu AG06466

Intervention Description

Lu AG06466 - capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo - capsule

Primary Outcome Measure Information:

Title

Number of Participants with Spasticity Response

Description

Spasticity response defined as ≥30% increase from baseline in spasticity Numerical Rating Scale (NRS) score

Time Frame

Baseline to Week 5

Title

Change from Baseline to Week 5 in Spasticity NRS Score

Time Frame

Baseline, Week 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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 exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Email contact via H. Lundbeck A/S

Organizational Affiliation

LundbeckClinicalTrials@Lundbeck.com

Official's Role

Study Director

Facility Information:

Facility Name

Mountain View Clinical Research

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Wake Research - Clinical Research Center of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Universitätsklinikum Düsseldorf

City

Dusseldorf NRW

ZIP/Postal Code

40225

Country

Germany

Facility Name

Neurostimulation Center for Movement Disorders

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Center of Neurology, Hertie Institute for Clinical Brain Research

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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