Clinical trial NCT04990219: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants with Spasticity Response
timeFrame: Baseline to Week 5
measure: Change from Baseline to Week 5 in Spasticity NRS Score
timeFrame: Baseline, Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Wake Research - Clinical Research Center of Nevada
state: Nevada
city: Dusseldorf NRW
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Mainz
country: Germany
facility: Neurostimulation Center for Movement Disorders
city: Tubingen
country: Germany
facility: Center of Neurology, Hertie Institute for Clinical Brain Research
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: