TerminatedPhase 3

Phase 3 Extension Study of Dexpramipexole in ALS

Stopped: The Initial Phase 3 Study (NCTO1281189) did not meet its primary efficacy endpoint.

United States, Australia, Belgium616 participantsStarted 2012-06

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Stu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Who Reported an Adverse Event

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Number of Subjects Who Experienced a Serious Adverse Event

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Number of Subjects Who Discontinued the Study Treatment Due to an Adverse Event

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Number of Participants With Potentially Clinically Significant Vital Sign Results

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Number of Participants With Potentially Clinically Significant Hematology Results

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Number of Participants With Potentially Clinically Significant Blood Chemistry Results

Timeframe: Baseline through end of study (maximum 226 days: approximately 32.2 weeks)

Trial details

NCT IDNCT01622088

SponsorKnopp Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02

Results submitted2022-03-10

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials