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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001230-18 | EudraCT Number |
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The study was terminated for strategic reasons
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The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).
The participants will be randomized to Lu AG06466 or placebo in a 2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo | Placebo Comparator | Participants will receive Lu AG06466-matching placebo orally once daily until Day 35/Week 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | Lu AG06466 - capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States | ||
| Johns Hopkins University |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Drug |
Placebo - capsule |
|
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Wake Research - Clinical Research Center of Nevada | Las Vegas | Nevada | 89106 | United States |
| Universitätsklinikum Düsseldorf | Dusseldorf NRW | 40225 | Germany |
| Neurostimulation Center for Movement Disorders | Mainz | 55131 | Germany |
| Center of Neurology, Hertie Institute for Clinical Brain Research | Tübingen | 72076 | Germany |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |