Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) (ALS)
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|ClinicalTrials.gov Identifier: NCT03580616|
Recruitment Status : Terminated (Study was terminated by the IRB due to continued noncompliance.)
First Posted : July 9, 2018
Last Update Posted : May 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: L-Serine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study|
|Actual Study Start Date :||October 24, 2018|
|Actual Primary Completion Date :||August 3, 2022|
|Actual Study Completion Date :||December 20, 2022|
L-Serine 15 grams orally twice a day as tolerated for 6 months
L-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.
- Dose tolerability based on subject reporting [ Time Frame: 6 months ]Dose tolerability is based on subject interviews and diary assessment evaluating the presence or absence of adverse events
- Efficacy based on ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Baseline, 1 year ]Change in ALSFRS-R questionnaire scale. The ALSFRS-R provides a physician-generated estimate of the patient's degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. The ALSFRS includes ten questions that ask the physician to rate his/her impression of the patients level of functional impairment in performing one of ten common tasks, e.g. climbing stairs. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 40=best.
- Efficacy based on neurological exam [ Time Frame: Baseline, 6 months ]Change in neurological exams with testing of muscle flexion and extension (scale: 0 to 5 with 0 being the most impaired) reflexes (scale: absent to brisk with absent being the most impaired), and sensation (scale: normal to abnormal), cranial nerves (scale: normal to abnormal on ocular movement, yes to no on Ptosis, normal to atrophy on tongue, and normal to abnormal on tongue movement).
- Efficacy based on pulmonary forced vital capacity [ Time Frame: Baseline, 6 months ]Change in % predicted in forced vital capacity
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of probable or definite ALS
- ALSFRS-R score >25 and FVC score ≥ 60% predicted
- If currently taking Riluzole and/or Edaravone/Radicava must be on stable dose for 3 months prior to Baseline/Screening. If the dosing has not been stable for 3 months prior to Baseline/Screening or if stopped due to an adverse event, the waiting period off the medication will be 7 days. If not on either of these medications may start if desired either or both medications after enrollment into study.
- 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 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.
- Diagnosis or previous history of symptomatic peripheral neuropathy. Patients with findings of peripheral neuropathy on electrodiagnostic tests only but no clinical symptoms at the time of enrollment are eligible.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580616
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Elijah W Stommel, MD,PHD||Dartmouth-Htichcock Medical Center|
|Responsible Party:||Elijah W. Stommel, Staff Physician, Neurology, Dartmouth-Hitchcock Medical Center|
|Other Study ID Numbers:||
|First Posted:||July 9, 2018 Key Record Dates|
|Last Update Posted:||May 9, 2023|
|Last Verified:||May 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases