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Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00531466
Recruitment Status : Terminated
First Posted : September 18, 2007
Last Update Posted : November 4, 2008
Sponsor:
Information provided by:
Avigen

September 14, 2007
September 18, 2007
November 4, 2008
September 2007
November 2008   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00531466 on ClinicalTrials.gov Archive Site
To determine preliminary efficacy in subjects with spasticity due to SCI [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
 
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
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:

  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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Muscle Spasticity
  • Drug: tolperisone HCl (AV650)
    One tablet orally three times a day for 28 days
  • Drug: Placebo
    One tablet orally three times a day for 28 days
  • Active Comparator: 1
    Intervention: Drug: tolperisone HCl (AV650)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
Same as current
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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.
  • 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00531466
AV650-014
No
Not Provided
Not Provided
Robert Elfont, MD, Avigen, Inc.
Avigen
Not Provided
Principal Investigator: Ralph J Marino, MD Thomas Jefferson University
Avigen
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP