|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 February 2023 |
|
Main ID: |
NCT04990219 |
|
Date of registration:
|
29/07/2021 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis
|
|
Scientific 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 |
|
Date of first enrolment:
|
September 27, 2021 |
|
Target sample size:
|
37 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT04990219 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Germany
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Email contact via H. Lundbeck A/S |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
LundbeckClinicalTrials@Lundbeck.com |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Sclerosis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Lu AG06466
|
|
Primary Outcome(s)
|
|
Change from Baseline to Week 5 in Spasticity NRS Score
[Time Frame: Baseline, Week 5]
|
|
Number of Participants with Spasticity Response
[Time Frame: Baseline to Week 5]
|
|
Secondary ID(s)
|
|
19366A
|
|
2021-001230-18
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|