Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT03580616
• Date of registration: 26/06/2018
• Prospective Registration: Yes
• Primary sponsor: Elijah W. Stommel
• Public title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) ALS
• Scientific title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study
• Date of first enrolment: October 24, 2018
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03580616
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Elijah W Stommel, MD,PHD
• Affiliation: Dartmouth-Htichcock Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Intervention(s)

Drug: L-Serine

Primary Outcome(s)

Dose tolerability based on subject reporting [Time Frame: 6 months]

Secondary Outcome(s)

Efficacy based on neurological exam [Time Frame: Baseline, 6 months]

Efficacy based on ALS Functional Rating Scale - Revised (ALSFRS-R) [Time Frame: Baseline, 1 year]

Efficacy based on pulmonary forced vital capacity [Time Frame: Baseline, 6 months]

Secondary ID(s)

D18095

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Brain Chemistry Labs, Institute for Ethnomedicine