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BX-1 in Spasticity Due to Multiple Sclerosis

NCT03756974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2021-05-05

No results posted yet for this study

Summary

To investigate the efficacy and safety of orally administered BX-1 compared to placebo in patients with spasticity due to multiple sclerosis not sufficiently controlled by current anti-spasticity medication

Conditions

  • Spasticity Due to Multiple Sclerosis

Interventions

DRUG

BX-1

BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.

DRUG

Placebo

Placebo of BX-1, oral solution

Sponsors & Collaborators

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Luitgard Spitznagel-Schminke · Bionorica SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Czechia
  • Germany
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756974 on ClinicalTrials.gov