Tolperisone in Acute Muscle Spasm of the Back



Status:Recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Other Indications, Metabolic
Therapuetic Areas:Musculoskeletal, Pharmacology / Toxicology, Other
Healthy:No
Age Range:18 - 65
Updated:3/29/2019
Start Date:February 1, 2019
End Date:July 2019
Contact:STAR Study
Email:NeuranaSTARStudy@precisionformedicine.com
Phone:760-688-0401

Use our guide to learn which trials are right for you!

Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back

This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy
and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three
times a day (TID) in approximately 400 male and female subjects experiencing back pain due to
or associated with muscle spasm.


Inclusion Criteria:

- Ambulatory

- Current acute back pain and/or stiffness due to acute and painful muscle spasm
starting within 7 days prior to study entry and more than 8 weeks after the last
episode of acute back pain.

- Pain of 4 or more on the subject "right now" rating of pain intensity (NRS scale of
0-10).

- Willing to discontinue all medication used for the treatment of pain or muscle spasm
on study entry.

- Pain localized below the neck and above the inferior gluteal folds.

- Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

- Unwillingness to stop taking pain or antispasmodic medication other than the study
medication (specifically opioid use [e.g., Vicodin], barbiturates, and cannabis).

- Chronic pain for the previous 3 months or longer, on more days than not.

- Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica
pain down the leg, or pain below the knee (indicating a lumber radiculopathy);
radicular pain in the upper extremity, radiating into the forearm or hand (indicating
a cervical radiculopathy).

- Concomitant severe pain in a region other than the back.

- Spinal surgery within 1 year of study entry.

- Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless
resolved for more than 1 year.

- Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture,
chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation [TENS],
physiotherapy).

- Subjects who test positive for alcohol by breathalyzer test.

- Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP)
isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with
tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
We found this trial at
43
sites
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48104
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Baytown, Texas 77512
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Bryan, Texas 77802
?
mi
from
Bryan, TX
Click here to add this to my saved trials
Cincinnati, Ohio 45246
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Edgewater, Florida 32132
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fresno, California 93726
?
mi
from
Fresno, CA
Click here to add this to my saved trials
4611 Northwest 53rd Avenue
Gainesville, Florida 32653
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Las Vegas, Nevada 89106
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72212
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
2008 Pacific Avenue
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
McAllen, Texas 78504
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
5801 Northwest 151st Street
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Newport News, Virginia 23606
?
mi
from
Newport News, VA
Click here to add this to my saved trials
860 Peachwood Drive
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Plano, Texas 75007
?
mi
from
Plano, TX
Click here to add this to my saved trials
Plantation, Florida 33313
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Rapid City, South Dakota 57702
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Sacramento, California
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Smithfield, Pennsylvania 15478
?
mi
from
Smithfield, PA
Click here to add this to my saved trials
Snellville, Georgia 30078
?
mi
from
Snellville, GA
Click here to add this to my saved trials
Tempe, Arizona 85283
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Wheaton, Maryland 20902
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
Williamsville, New York 14221
?
mi
from
Williamsville, NY
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials