UnknownPhase 1

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)

Canada18 participantsStarted 2019-10-10

Plain-language summary

Single ascending doses of AP-101 will be administered by intravenous (IV) infusion

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical conditions such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
✓. Surgical sterilization

What they're measuring

Number of Participants With One or More Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)

Timeframe: Baseline up to day 84

Number of participants with abnormalities in vital signs, clinical laboratory assessments, physical or neurological examinations, or electrocardiograms (ECGs)

Timeframe: Baseline up to day 84

Trial details

NCT IDNCT03981536

SponsorAL-S Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-02

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials