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 States616 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 range18 Years – 80 Years

SexALL

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…

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)

Number of Participants With Potentially Clinically Significant ECG 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