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NCT00015444 · ClinicalTrials.gov registry record
Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
A clinical trial of Primary Lateral Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 189
- Enrollment target
- 1
- Study location
NCT00015444 is a study of Primary Lateral Sclerosis that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 189 participants, below the 254-participant average among 9 other Primary Lateral Sclerosis trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00015444, a study of Primary Lateral Sclerosis, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 189 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: The objectives of this protocol are: to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols, to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration, to investigate proposed etiologies, risk factors, and biomarkers for the development of these disorders and for disease progression Study Population: 240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral sclerosis or related upper motor neuron disorder Design: Patients who have been referred by physicians for primary lateral sclerosis will undergo a screening evaluation at the first visit. The screening visit will include review of outside medical records, neurological examination, and diagnostic testing to determine possible causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis by history or examination will be followed to determine the natural history of this disorder. Measures of motor and cognitive function will be made at baseline and follow-up visits to follow clinical progression. Magnetic resonance imaging will be carried out to determine if imaging changes occur over time. Patients identified in this protocol who are eligible for other research protocols will be invited to participate in additional protocols. Outcome Measures: Clinical progression will be documented by measures of finger-tapping, timed gait, speech. The association between clinical progression and MRI measures will be assessed as a secondary outcome....
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2001-05-01 |
| Est. Completion | 2019-04-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00015444
The ClinicalTrials.gov registry entry for NCT00015444 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 9 other Primary Lateral Sclerosis trials with a reported enrollment target (26% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Lateral Sclerosis appearing as the primary indexed condition, and to 0 interventions.
NCT00015444 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00015444 about?
NCT00015444 is a clinical study titled "Screening and Natural History: Primary Lateral Sclerosis and Related Disorders". Objective: The objectives of this protocol are: to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols, to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration, to in...
What is the current status of trial NCT00015444?
This trial is currently completed. The enrollment target is 189 participants. The study started on 2001-05-01. Estimated completion is 2019-04-24.
What conditions does trial NCT00015444 study?
This clinical trial studies the following conditions: Primary Lateral Sclerosis.
Who is sponsoring clinical trial NCT00015444?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00015444 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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