Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study

Study Purpose:

The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Elijah W Stommel, MD,PHD, Dartmouth-Htichcock Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT03580616

Neals Affiliated?

No

Coordinating Center Contact Information

Dartmouth-Htichcock Medical Center
Catherine L Andrews, RN, CCRN / .(JavaScript must be enabled to view this email address) / 603-650-4633
.(JavaScript must be enabled to view this email address) New Hampshire United States

Full Study Summary:

All patients will receive the same dose of the study treatment over 6 months. For each participant the study will last approximately one year with follow up visits after the treatment period of 6 months is completed. The visits will include blood draws, electromyography (EMG), vital sign checks, neurological and physical exams, pulmonary testing with forced vital capacity (FVC), and questionnaires.

Study Sponsor:

Elijah W. Stommel

Participant Duration:

Estimated Enrollment:

50

Estimated Study Start Date:

07/31/2018

Estimated Study Completion Date:

06/30/2022

Posting Last Modified Date:

12/14/2018

Date Study Added to alsconsortium.org:

07/10/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    60

    Time since Symptom Onset:

    Time since Diagnosis:

    <36 months

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Diagnosis of probable or definite ALS
    ALSFRS-R score >25 and FVC score ≥ 60% predicted
    If currently taking Riluzole and Edaravone/Radicava for 3 months prior to Baseline/Screening or not at all

    Exclusion Criteria:

    Diagnosis of probable or definite ALS more than 3 years prior to study enrollment
    Diagnosis or previous history of ischemic stroke, brain tumor, uncontrolled diabetes, renal insufficiency, or severe hypertension.
    Diagnosis or previous history of peripheral neuropathy of any other comorbid progressive neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy Body disease, Pick's disease, Huntington's disease, Progressive Supranuclear palsy. ALS patients diagnosed with frontotemporal dementia will not be excluded from this study.
    Undergoing any chemotherapy or radiation therapy for any cancer
    Any medical condition likely to interfere with the conduct of the trial or survival of the patient during this study period
    Pregnant women or women who are breast feeding
    Has taken L-Serine supplement within 30 days prior to start of study drug

  • Site Contact Information

    Dartmouth-Hitchcock Medical Center
    Catherine L Andrews, RN / .(JavaScript must be enabled to view this email address) / 603-650-4633
    Lebanon, New Hampshire 03756
    United States