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

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04990219

Collaborator

(none)

Enrollment

Locations

Arms

18.8

Anticipated Duration (Months)

11.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Lu AG06466 Drug: Placebo	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 27, 2021

Anticipated Primary Completion Date :

Apr 8, 2023

Anticipated Study Completion Date :

Apr 22, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mountain View Clinical Research	Denver	Colorado	United States	80209
2	Johns Hopkins University	Baltimore	Maryland	United States	21287
3	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
4	Wake Research - Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89106
5	Universitätsklinikum Düsseldorf	Dusseldorf NRW		Germany	40225
6	Neurostimulation Center for Movement Disorders	Mainz		Germany	55131
7	Center of Neurology, Hertie Institute for Clinical Brain Research	Tubingen		Germany	72076

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT04990219

Other Study ID Numbers:

19366A
2021-001230-18

First Posted:

Aug 4, 2021

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Aug 8, 2022