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Lu AG06466 for Multiple Sclerosis

Phase 1
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 5
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help reduce spasticity in people with MS.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 5 in Spasticity NRS Score
Number of Participants with Spasticity Response

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lu AG06466Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG06466
2020
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,546 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
110 Patients Enrolled for Multiple Sclerosis
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
58,303 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must participants fulfill to be eligible for this research project?

"The trial is currently recruiting 78 individuals with multiple sclerosis, aged between 18 and 70. To be eligible, patients must have a diagnosis of MS as per the 2017 McDonald criteria; have stable symptoms (with no relapses or steady Expanded Disability Status Scale [EDSS] score) over 6 months prior to screening; experience spasticity for 90 days before being screened; not change any medications or non-pharmacological treatments meant to manage their condition in the past 30 days leading up to screening; demonstrate walking impairments caused by lower limb spasticity."

Answered by AI

Is Lu AG06466 considered to be a risk-free compound for human consumption?

"Our assessment of Lu AG06466's safety landed on a score of 1 as it is currently in the first stage of clinical trials and has limited data backing its efficacy."

Answered by AI

What is the current enrollment size of this experiment?

"The trial's sponsor, H. Lundbeck A/S, seeks 78 patients with matching inclusion criteria to fully operationalize the study. Two of the sites are Johns Hopkins University located in Denver and Mountain View Clinical Research situated in Saint Louis."

Answered by AI

Is enrollment still open for this clinical research project?

"Affirmative. According to clinicaltrials.gov, the study began recruiting on September 27th 2021 and has recently been updated on October 10 2022. 78 participants are necessary between 5 distinct medical centres."

Answered by AI

How many healthcare facilities are currently conducting this research?

"This clinical trial has 5 enrolment sites, including Johns Hopkins University in Denver, Mountain View Clinical Research in Saint Louis, and Washington University School of Medicine in Las Vegas. Additionally, there are two other recruiting centres across the country."

Answered by AI

Is participation in this experiment restricted to persons over the age of 18?

"According to the trial's specifications, individuals aged 18-70 may be eligible for enrollment."

Answered by AI
~11 spots leftby Apr 2025