A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis

NCT04990219 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 19366A2021-001230-18
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 7

Brief Summary

The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Spasticity Response

  Spasticity response defined as ≥30% increase from baseline in spasticity Numerical Rating Scale (NRS) score

  Baseline to Week 5

• Change from Baseline to Week 5 in Spasticity NRS Score

  Baseline, Week 5

Study Arms (2)

Lu AG06466

EXPERIMENTAL

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.

Drug: Lu AG06466

Placebo

PLACEBO COMPARATOR

Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5.

Drug: Placebo

Interventions

Lu AG06466 DRUG

Lu AG06466 - capsule

Lu AG06466

Placebo DRUG

Placebo - capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (7)

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Wake Research - Clinical Research Center of Nevada

Las Vegas, Nevada, 89106, United States

Location

Universitätsklinikum Düsseldorf

Dusseldorf NRW, 40225, Germany

Location

Neurostimulation Center for Movement Disorders

Mainz, 55131, Germany

Location

Center of Neurology, Hertie Institute for Clinical Brain Research

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 4, 2021
• Study Start: September 27, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 31, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-01

Locations

US (4); DE (3)