Phase 3 Extension Study of Dexpramipexole in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Dexpramipexole
Intervention description: Oral tablet 150 mg given twice daily (BID)
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 616.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS, Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.