Phase 3 Extension Study of Dexpramipexole in ALS

Stopped early · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Key facts

Study ID

NCT01622088

Run by

Knopp Biosciences

People needed

616

Starts

2012-06-01

Expected to finish

2013-02-01

Last updated by the study team

2022-05-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or have the consent confirmed by a witness if unable to write) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Subject was enrolled in either CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject has completed their last visit in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment.

You may not qualify if…

• Subject withdrew prematurely from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject permanently discontinued study treatment in Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) for any reason other than enrollment into this study.
• Subject from Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189) has a significant change in medical history (including laboratory tests or a clinically significant condition) that in the opinion of the Investigator would impair the subject's medical fitness for participation and preclude treatment.
• Female subject who is pregnant or breastfeeding.
• Subject is currently enrolled in any investigational drug study other than Study CL211 (NCT00931944) or Study 223AS302 (NCTO1281189).
• Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication.
• Subject is unwilling or unable to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. At a minimum, subjects who are not able to travel to the study site must be willing to agree to remote blood draws for clinical laboratory evaluations and telephone visits to report Adverse Events, concomitant medications, and Amyotrophic Lateral Sclerosis Functional Rating Scale (revised) (ALSFRS-R) scores.

Where it is running

• University of California at San Francisco - Fresno — Fresno, California, United States
• University of California, Irvine — Orange, California, United States
• University of California, Davis — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of South Florida Medical Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• St. Mary's Health Care — Grand Rapids, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Neurology Associates, P.C. — Lincoln, Nebraska, United States
• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University — New York, New York, United States
• Research Foundation of the State University of New York — Syracuse, New York, United States
• Barrow Neurological Institute - St. Joseph's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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