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NCT03929068 · ClinicalTrials.gov registry record · Phase 1

Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis

A Phase 1 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT03929068 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 15 participants.

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The verdict

NCT03929068, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in ALS and PLS patients with severe spasticity should be studied. The investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in ALS and PLS patients.

Interventions

  • DRUG carbidopa-levodopa
  • DRUG Placebo Oral Tablet

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-05-13
Est. Completion 2022-07-08
Phase Phase 1

What the Registry Record Tells You About NCT03929068

The ClinicalTrials.gov registry entry for NCT03929068 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which carbidopa-levodopa is the first listed.

NCT03929068 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03929068 about?

NCT03929068 is a clinical study titled "Sinemet for Spasticity and Function in Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis". Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa (Sinemet) to attempt to improve spasticity in ALS and PLS patients. However, data on the efficacy of carbidopa/levodopa is limited. Given the limite...

What is the current status of trial NCT03929068?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-05-13. Estimated completion is 2022-07-08.

What interventions are being tested in trial NCT03929068?

The interventions under investigation include: carbidopa-levodopa (DRUG), Placebo Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT03929068?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.