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Active (not recruiting) Phase 2 2024-514617-35-00

P2-IMU-838-PMS - Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis (Calliper)

Phase 2 – studying effectiveness and dosage
Conditions: Progressive forms of Multiple Sclerosis

Sponsor: Immunic AG

trial.available_in: БГ
Overview
Trial status: Authorised Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period Annualized rate of percent brain volume change (PBVC) during MT period.
Description
Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period
Who can participate
Age group: 18-64 years Gender: Female, Male Target enrollment: 230 participants
Interventions
IMU-838 22.5 mg tablet
Drug
Placebo for IMU-838 Tablets
Drug
IMU-838 45 mg tablet
Drug
Locations 6
Bulgaria (1)
Czech Republic (1)
Germany (1)
Netherlands (1)
Poland (1)
Romania (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
12.09.2024
Registry ID
2024-514617-35-00
Source
euclinicaltrials.eu
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