Phase 3 Study of Dexpramipexole in ALS (EMPOWER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01281189
First received: January 20, 2011
Last updated: September 12, 2013
Last verified: August 2013

January 20, 2011
September 12, 2013
March 2011
November 2012   (final data collection date for primary outcome measure)
A joint rank of functional outcomes adjusted for mortality. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01281189 on ClinicalTrials.gov Archive Site
  • Time to death or respiratory insufficiency [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Respiratory decline: time to reach less than or equal to 50% of predicted upright slow vital capacity (SVC) or death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in ALS-related health quality, as measured by change in the total score on the Amyotrophic Lateral Sclerosis Assessment Questionnaire-5-Item Form (ALSAQ-5) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Population pharmacokinetics. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
  • Time to death using all available follow-up data. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Respiratory decline: time to reach 50% of predicted upright SVC or death. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in ALS-related health quality, as measured by change in the total score on the Amyotrophic Lateral Sclerosis Assessment Questionnaire-5-Item Form (ALSAQ-5) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in muscle strength measurements (MSM), as determined by the overall megascore for hand-held dynamometry (HHD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events, vital signs, clinical laboratory assessments, physical examination, electrocardiogram tests, and body weight. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Population pharmacokinetics. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 3 Study of Dexpramipexole in ALS
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Drug: Dexpramipexole
    Oral tablet 150mg twice daily for up to 18 months.
    Other Name: BIIB050
  • Drug: Placebo
    Oral tablet twice daily for up to 18 months.
  • Experimental: Dexpramipexole
    Intervention: Drug: Dexpramipexole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
943
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18 to 80 years old, inclusive, on Day 1.
  • Diagnosis of sporadic or familial ALS.
  • Onset of first ALS symptoms within 24 months prior to Day 1.
  • World Federation of Neurology El Escorial criteria are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis.
  • Upright slow vital capacity (SVC) of 65% or more at screening.
  • Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.
  • Must be able to swallow tablets at the time of study entry.

Exclusion Criteria:

  • Other medically significant illness.
  • Clinically significant abnormal laboratory values.
  • Pregnant women or women breastfeeding.
  • Prior exposure to dexpramipexole.
  • Currently taking pramipexole or other dopamine agonists.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   Belgium,   Ireland,   Germany,   Australia,   France,   Canada,   Spain,   United Kingdom,   Sweden
 
NCT01281189
223AS302, EUDRA CT NO: 2010-022818-19
Yes
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP