Muscle SpasticityPhase 2NCT00531466
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
A Phase 2 study testing tolperisone HCl (AV650) in people with Muscle Spasticity, run by Avigen at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- tolperisone HCl (AV650)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who provide written informed consent.
- Male or female subjects aged 18 to 70 years.
- In the judgment of the Principal Investigator, able to comply with protocol requirements.
- Subjects willing and able to withdraw from other anti-spasmodic/muscle relaxant drugs for at least two weeks before randomization (including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine).
- Neurological level between C-4 and T-12 spinal cord levels.
- SCI duration of 6 or more months.
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- Muscle tone sufficient to score at least two (2) on the Ashworth Scale for at least one of the following lower muscle groups: ankle plantar flexors (gastrocnemius), knee extensors (quadriceps), knee flexors (hamstrings) and/or hip adductors (adductors) and seven (7) for the most spastic limb.
- ASIA Impairment Scale Exam score of B, C or D.
- Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.
- Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).
Who cannot join
- Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.
- Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
- Any recent history of mental illness, drug addiction, recreational drug use, or alcoholism and/or any similar condition that the investigator feels should prohibit study participation.
- Any significant illness during the four weeks preceding Study Day 1.
- History of cancer or inflammatory arthritis of large joints.
- History of gastric or duodenal ulcer.
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- Concurrent symptomatic urinary tract infections with fever.
- Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.
- ASIA Impairment Scale score of A or E.
- Uncontrolled hypertension or hypotension.
- Percussive tenderness of vertebral body or spinous process.
- Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.
- Subjects known to be Hepatitis B or HIV positive.
- Female subjects who are pregnant or nursing.
- Subjects who have received an investigational drug within 30 days before Screening visit.
- Subjects with any documented episodes of seizures.
- Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.
- Use of rescue medication(s) within 48 hours of baseline procedures.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
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
Carolinas Rehabilitation
Charlotte, North Carolina, 28203
University of Miami Miller School of Medicine
Miami, Florida, 33136
Southern California Clinical Research, Inc.
Pasadena, California, 91106
Jefferson Medical College of Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Kessler Institute for Rehab.
West Orange, New Jersey, 07052
Canada1 site
Rehabilitation Hospital Health Sciences Centre
Winnipeg, Quebec, R3A 1M4
About this study
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
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
- To determine whether AV650 is safe for patients with spinal cord injury;
- To assess what the body does with AV650 once it is ingested; and,
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
- Conditions
- Muscle Spasticity
- Being tested
- tolperisone HCl (AV650), Placebo
- Keywords
- Spinal cord injury
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolperisone HCl (AV650)Drug
One tablet orally three times a day for 28 days
PlaceboDrug
One tablet orally three times a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: tolperisone HCl (AV650) |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.
Measured: 1 month
Secondary outcomes (1)
To determine preliminary efficacy in subjects with spasticity due to SCI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph J Marino, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531466
- Sponsor's protocol ID
- AV650-014
- Status last verified
- Nov 2008
- First submitted
- 14 Sep 2007
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00531466
- Acronym / sponsor ID
- AV650-014
- Conditions
- Muscle Spasticity
- Keywords
- Spinal cord injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AvigenIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
- To determine whether AV650 is safe for patients with spinal cord injury;
- To assess what the body does with AV650 once it is ingested; and,
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tolperisone HCl (AV650) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who provide written informed consent.
- Male or female subjects aged 18 to 70 years.
- In the judgment of the Principal Investigator, able to comply with protocol requirements.
- Subjects willing and able to withdraw from other anti-spasmodic/muscle relaxant drugs for at least two weeks before randomization (including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine).
- Neurological level between C-4 and T-12 spinal cord levels.
Key exclusion criteria (18 listed)
- Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.
- Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
- Any recent history of mental illness, drug addiction, recreational drug use, or alcoholism and/or any similar condition that the investigator feels should prohibit study participation.
- Any significant illness during the four weeks preceding Study Day 1.
- History of cancer or inflammatory arthritis of large joints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolperisone HCl (AV650)One tablet orally three times a day for 28 days | Drug | 1 |
| PlaceboOne tablet orally three times a day for 28 days | Drug | 2 |
Primary outcome
To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury.
Time frame: 1 month
1 secondary outcome
To determine preliminary efficacy in subjects with spasticity due to SCI
Time frame: 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph J Marino, MD principal investigator
Thomas Jefferson University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tolperisone HCl (AV650) in people with Muscle Spasticity, run by Avigen at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety, tolerability and PK profile of AV650 in subjects with spasticity due to spinal cord injury. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2008.