Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) (ALS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03580616|
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: L-Serine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 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|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 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
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
|Contact: Catherine L. Andrews, RN, CCRN||603-650-4633||Catherine.L.Andrews@hitchcock.org|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Catherine L. Andrews, RN 603-650-4633 firstname.lastname@example.org|
|Principal Investigator:||Elijah W Stommel, MD,PHD||Dartmouth-Htichcock Medical Center|