Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916966
Other study ID # D06019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date September 2023

Study information

Verified date April 2024
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - ALS - Non-neurodegenerative controls - Can willingly give consent - Over 18 years of age Exclusion Criteria: - Cannot give consent - Under 18 years of age

Study Design


Intervention

Other:
Patient Registry
Patient Registry

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire for Environmental Exposures, Toxins, and Neurological Disease 1 year
See also
  Status Clinical Trial Phase
Terminated NCT04428775 - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease Phase 2
Recruiting NCT04998305 - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps Phase 1/Phase 2
Recruiting NCT05951556 - Telehealth Implementation of Brain-Computer Interface N/A
Terminated NCT04579666 - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT04082832 - CuATSM Compared With Placebo for Treatment of ALS/MND Phase 2/Phase 3
Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed NCT02496767 - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year Phase 3
Recruiting NCT04816227 - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting NCT04494256 - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation Phase 1/Phase 2
Completed NCT03706391 - Study of ALS Reversals 4: LifeTime Exposures
Recruiting NCT04882904 - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. N/A
Completed NCT04557410 - Open Label Study: Treatment of ALS Fatigue With PolyMVA Phase 1
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Not yet recruiting NCT04220190 - RAPA-501 Therapy for ALS Phase 2/Phase 3
Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A