A Study of Lu AG06466 for the Treatment of Spasticity in Participants
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
What it found
The trial ended early for another reason (see below).
Reason given: The study was terminated for strategic reasons
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Lu AG06466
Placebo
- Placebo
What it measured
Main measures
Number of Participants with Spasticity Response
Baseline to Week 5
SpasticityChange from Baseline to Week 5 in Spasticity NRS Score
Baseline, Week 5
Spasticity
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).
Papers
Loading reviews and guidelines…
History
Started
Sept 2021
Main results due
Jan 2023
Finished
Jan 2023