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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2011-006119-70-BE
• Date of registration: 14/06/2012
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION
• Date of first enrolment: 13/08/2012
• Target sample size: 850
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006119-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Germany, Ireland, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: ALS Clinical Trials Teams
• Affiliation: Biogen Idec Research Limited

• Name: ALS Clinical Trials Teams
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1 Level: PT Classification code 10002026 Term: Amyotrophic lateral sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Pharmaceutical Form: Film-coated tablet
CAS Number: 908244-04-2
Current Sponsor code: BIIB050 / KNS-760704
Other descriptive name: Dexpramipexole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: As necessary

Primary end point(s): - incidence of AEs and SAEs
- discontinuation of study treatment due to an AE
- changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead ECGs, and body weight
- incidence of laboratory abnormalities

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.

Main Objective: The primary objective of the study is to evaluate the long-term safety profile of dexpramipexole in subjects with ALS.

Secondary Outcome(s)

Secondary end point(s): - change in ALSFRS-R score
- decline in SNIP
- time to death
- 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

Secondary ID(s)

223AS304

2011-006119-70-SE

Source(s) of Monetary Support

Biogen Idec Research Limited