Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Public ClinicalTrials.gov record NCT00531466. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AV650-014: A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes: 1. To determine whether AV650 is safe for patients with spinal cord injury; 2. To assess what the body does with AV650 once it is ingested; and, 3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
Study identification
- NCT ID
- NCT00531466
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2007
- Primary completion
- Oct 31, 2008
- Completion
- Oct 31, 2008
- Last update posted
- Nov 3, 2008
2007 – 2008
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Clinical Research, Inc. | Pasadena | California | 91106 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Shepherd Center, Inc. | Atlanta | Georgia | 30309 | — |
| Internal Center for Spinal Cord Injury Kennedy Kreiger Institute | Baltimore | Maryland | 21205 | — |
| Kernan Orthopaedics & Rehab. Hospital | Baltimore | Maryland | 21207 | — |
| Kessler Institute for Rehab. | West Orange | New Jersey | 07052 | — |
| Carolinas Rehabilitation | Charlotte | North Carolina | 28203 | — |
| Jefferson Medical College of Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00531466, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2008 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00531466 live on ClinicalTrials.gov.