The effect of methylprednisolon plus mitoxantrone in the treatment of progressive multiple sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201012245393N1

Enrollment

Registered

2011-04-05

Start date

2010-06-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: 20mg Mitoxantrone plus 500 mg methylprodnisolon during 6 months follow up. Intervention 2: Control group: 20mg mitoxantrone (injection) and 100cc dextrose water 5%

Treatment - Drugs

Placebo

Intervention group: 20mg Mitoxantrone plus 500 mg methylprodnisolon during 6 months follow up

Control group: 20mg mitoxantrone (injection) and 100cc dextrose water 5% (control) with six months follow up

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with progressive multiple sclerosis, Informed consent, age between 20-50 year Exclusion criteria: HIV+ patients, cancer, heart failure, immunodeficiency patients, patients with neutrophil count less than 1500

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Heartburn. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Vomitting. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Anorexia. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Hair loss. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Leukopenia. Timepoint: 6 months after the beginning of study. Method of measurement: through hematologic test CBC.	—

Measure

Time frame

Heartburn. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Vomitting. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Anorexia. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Hair loss. Timepoint: 6 months after the beginning of study. Method of measurement: ask from patients.;Leukopenia. Timepoint: 6 months after the beginning of study. Method of measurement: through hematologic test CBC.

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Primary

Measure	Time frame
Expanded Disability Status Scale. Timepoint: 6 months after the beginning of study. Method of measurement: by a checlkist, standard criteria.;Muscular power after treatment. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.;Cerebellum symptoms. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.;MRI findings (number of lesions) after treatment. Timepoint: 6 months after the beginning of study. Method of measurement: MRI.;Cranial nerves involvement. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.	—

Measure

Time frame

Expanded Disability Status Scale. Timepoint: 6 months after the beginning of study. Method of measurement: by a checlkist, standard criteria.;Muscular power after treatment. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.;Cerebellum symptoms. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.;MRI findings (number of lesions) after treatment. Timepoint: 6 months after the beginning of study. Method of measurement: MRI.;Cranial nerves involvement. Timepoint: 6 months after the beginning of study. Method of measurement: physical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Reza Soltani

Scientific Soceity of Medicine, Islamic Azad Univerisity branch Yazd

hrsgmed@yahoo.com+98 913 351 8033

Outcome results

None listed

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