Study Evaluating Mitoxantrone in Multiple Sclerosis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00146159

Purpose

The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.

Condition	Intervention	Phase
Secondary Progressive Multiple Sclerosis	Drug: Mitoxantrone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

derivations of EDSS and relapses; MRI (baseline, 2 years) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	336
Study Start Date:	March 2005
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1st group: 12 mg Mitoxantrone/m²	Drug: Mitoxantrone dosage
2: Experimental 2nd group: 9mg Mitoxantrone/m²	Drug: Mitoxantrone dosage
3: Experimental 3rd group: 5mg Mitoxantrone/m²	Drug: Mitoxantrone dosage

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Secondary progressive MS in an active stage
EDSS between 3 and 6

Exclusion Criteria:

Benign or primary progressive MS
Patients with cardiac risk factors
Patients who have already received mitoxantrone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146159

Locations

Germany

Wiesbaden, Germany, D-65191

Marburg, Germany, D-35039

Gießen, Germany, D-35385

Düsseldorf, Germany, D-40479

Berlin, Germany, D-13347

Berg, Germany, D-82335

Düsseldorf, Germany, D-40225

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Clinical Trials Registry Specialist) )
Study ID Numbers:	0906E-100925
Study First Received:	September 1, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00146159 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wyeth:

Multiple Sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Sclerosis

Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis
Pharmacologic Actions
Multiple Sclerosis, Chronic Progressive
Neoplastic Processes
Neoplasms

Multiple Sclerosis
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Central Nervous System Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on September 04, 2009