A Study of Lu AG06466 for the Treatment of Spasticity in Participants With 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 to week 5

Summary

This trial is testing a new drug called Lu AG06466 to see if it can help people with multiple sclerosis who have stiff muscles and spasms. The drug likely works by helping control muscle movements through the nervous system.

Eligible Conditions

Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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