NCT00223301

Brief Summary

  1. 1.To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS.
  2. 2.To document changes in exacerbation frequency,
  3. 3.To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),
  4. 4.To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI),
  5. 5.To document changes in quality of life measures,
  6. 6.To assess fatigue with the validated fatigue assessment inventory,
  7. 7.Neuroimmunological studies:At baseline, 6 and 12 months after treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Jul 2004

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

September 19, 2005

Last Update Submit

April 18, 2013

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less

Secondary Outcomes (8)

  • To document changes in exacerbation frequency

  • To document the incidence of mild, moderate, and severe exacerbations in the treated groups.

  • To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.

  • To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).

  • To assess fatigue with the validated fatigue assessment inventory

  • +3 more secondary outcomes

Interventions

Mycophenolate Mofetil (cellcept)DRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 21-45 inclusive
  • Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .
  • At least one exacerbation in the preceding two years
  • Written informed consent.

You may not qualify if:

  • Primary progressive, secondary progressive or progressive relapsing MS.
  • Corticosteroids during the 60 days prior to study entry.
  • Treatment with plasma exchange within 90 days of preenrollment.
  • No prior exposure to total lymphoid irradiation.
  • No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs
  • A clinical relapse within 60 days prior to enrollment.
  • Pregnant/breastfeeding.
  • Patients with major medical illnesses.
  • Cognitive impairment interfering with ability to comply with the protocol.
  • Patients who need to remain on any contraindicated medication.
  • Diabetic
  • Inability to undergo MRI scan
  • On intravenous immunoglobulin protocol
  • HIV+ or RPR+
  • Females of childbearing age who have not undergone a sterilization procedure must be willing to practice effective birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8806, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Elliot Frohman, MD/PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

US(1)