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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04990219
• Other study ID #: 19366A
• Secondary ID: 2021-001230-18
• Status: Terminated
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 31, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Lu AG06466
Lu AG06466 - capsule
• Placebo
Placebo - capsule

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf	Dusseldorf NRW
Germany	Neurostimulation Center for Movement Disorders	Mainz
Germany	Center of Neurology, Hertie Institute for Clinical Brain Research	Tubingen
United States	Johns Hopkins University	Baltimore	Maryland
United States	Mountain View Clinical Research	Denver	Colorado
United States	Wake Research - Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline to Week 5 in Spasticity NRS Score		Baseline, Week 5