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Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis.

Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002856-14-DE
Enrollment
Unknown
Registered
2006-11-07
Start date
2007-02-21
Completion date
Unknown
Last updated
2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary progressive or progressive relapsing multiple sclerosis with signs of disease activity in terms of inflammation MedDRA version: 8.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis

Interventions

Trade Name: Ovastat 1000 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: TREOSULFAN CAS Number: 299752 Concentration unit: mg milligram(s) Concentration type: equal Concent

Sponsors

medac Gesellschaft für klinische Spezialpräparate mbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026