An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

Phase 3

Withdrawn

Conditions: Amyotrophic Lateral Sclerosis
Lou Gehrig's disease
10029317

Registration Number: NL-OMON37292

Lead Sponsor: Biogen Idec Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 37

Inclusion Criteria

1. 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.;2. Subject was enrolled in either Study CL211 or Study 223AS302.;3. Subject has completed their last visit in Study CL211 or Study 223AS302.;4. 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.

Exclusion Criteria

1. Subject withdrew prematurely from Study CL211 or Study 223AS302.;2. Subject permanently discontinued study treatment in Study CL211 or Study 223AS302 for any reason other than enrollment into this study.;3. Subject from Study CL211 or Study 223AS302 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.;4. Female subject who is pregnant or breastfeeding.;5. Subject is currently enrolled in any investigational drug study other than Study CL211 or Study 223AS302.;6. Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication;7. 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 AEs, concomitant medications, and ALSFRS-R scores.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>The following primary endpoints will be evaluated:<br /><br>• incidence of adverse events (AEs) and serious adverse events (SAEs)<br /><br>• discontinuation of study treatment due to an AE<br /><br>• changes in vital signs, clinical laboratory assessments (hematology, blood<br /><br>chemistry, and urinalysis), 12-lead electrocardiograms (ECGs) and body weight<br /><br>• incidence of laboratory abnormalities</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>The following secondary endpoints will be evaluated:<br /><br>• change in ALS Functional Rating Scale-Revised (ALSFRS-R) score<br /><br>• decline in sniff nasal inspiratory pressure (SNIP)<br /><br>• time to death<br /><br>• time to death or death equivalent (tracheostomy or permanent assisted<br /><br>ventilation [PAV], defined as use of noninvasive ventilation [NIV] for >= 22<br /><br>hours per day for >= 10 days</p><br>