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NCT00706147 · ClinicalTrials.gov registry record · Phase 2
Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT00706147 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by University of Miami. The registered enrollment target is 38 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00706147, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study will be to demonstrate the safety, tolerability, and efficacy of arimoclomol in subjects with SOD1 positive familial Amyotrophic Lateral Sclerosis (ALS). This type of ALS is HEREDITARY (runs in families), and at least one other person in the family must have had ALS. Study hypotheses: Arimoclomol, taken at a dose of 200 mg three times daily will improve survival as defined by time to death, tracheostomy or permanent assisted ventilation. In addition, it will be safe and well tolerated in subjects with SOD1 positive familial ALS. Funding Source - FDA-OOPD
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Arimoclomol
Study Locations (2)
Florida
- University of Miami Miller School of Medicine - Miami
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706147
The ClinicalTrials.gov registry entry for NCT00706147 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (96% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00706147 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00706147 about?
NCT00706147 is a clinical study titled "Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis". The purpose of this study will be to demonstrate the safety, tolerability, and efficacy of arimoclomol in subjects with SOD1 positive familial Amyotrophic Lateral Sclerosis (ALS). This type of ALS is HEREDITARY (runs in families), and at least one other person in the family must have had ALS. Study...
What is the current status of trial NCT00706147?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-01. Estimated completion is 2016-11.
What conditions does trial NCT00706147 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT00706147?
The interventions under investigation include: Placebo (DRUG), Arimoclomol (DRUG).
Who is sponsoring clinical trial NCT00706147?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00706147 being conducted?
This trial has 2 study locations across Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.