Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)

Conditions: Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-006119-70-DE

Lead Sponsor: Biogen Idec Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 850

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. For further details of contraceptive requirements for this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 739
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 111

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the long-term safety profile of dexpramipexole in subjects with ALS.;Secondary Objective: The secondary objective of this study is to evaluate the long-term efficacy of dexpramipexole in this study population using clinical endpoints measuring function and survival.;Primary end point(s): - incidence of AEs and SAEs <br>- discontinuation of study treatment due to an AE <br>- changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead ECGs, and body weight <br>- incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: As necessary

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - change in ALSFRS-R score <br>- decline in SNIP <br>- time to death <br>- time to death or death equivalent (tracheostomy or permanent assisted ventilation [PAV], defined as use of noninvasive ventilation [NIV] for =22 hours per day for =10 days);Timepoint(s) of evaluation of this end point: As necessary