Consensus Guidelines for the Design and Implementation of Clinical Trials in ALS

Robert G Miller M.D.

Chairman Clinical Trials Consortium

Theodore L. Munsat M.D.

Conference Organizer

Chairman WFN Research Committees

Michael Swash M.D.

Chairman WFN Committee on Motor Neuron Diseases

Benjamin Rix Brooks M.D.

Conference Organizer for the Committee on Motor Neuron Diseases World Federation of Neurology

Contents:

• Introduction
• ALS Clinical Trials Guidelines
• Appendix One - Measurement Techniques in ALS Clinical Trials
• Appendix Two - ALS Clinical Trial Disclosure of Information Guidelines
• Appendix Three - Maximum Voluntary Isometric Contraction (MVIC) and Other Strength Measures
• Appendix Four - Quality of Life
• Appendix Five - Statistical Considerations
• Appendix Six - Respiratory Issues in Clinical Trials
• Appendix Seven - Bulbar Tests
• Appendix Eight - Workshop Chairs, Cochairs, Participants, and Attendees
• Appendix Nine - Conference Support and Acknowledgements
• References

Correspondence:
Robert G. Miller, M.D.
California Pacific Medical Center
2324 Sacramento Street, Suite 150
San Francisco, California 94115 USA
Telephone: 415-923-3604
Fax: 415-923-6567
Email: rmiller@cooper.cpmc.org