Clinical trial NCT03802565: Tolperisone in Acute Muscle Spasm of the Back
Official title: Dose Ranging Study of Tolperisone in Acute Muscle Spasm of the Back
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain
Acute Pain
Back Spasm Upper Back
Back Strain
Muscle Cramp
Muscle Spasm
Low Back Pain
Lead sponsor: Neurana Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 Numeric Rating Scale (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).

Primary outcomes:
measure: Mean Effect Size in Subjected-Rated Pain
timeFrame: Day 1 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Tennessee Valley Pain Consultants
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Little Rock
country: United States
facility: Center of Applied Research
state: Arkansas
city: Fresno
country: United States
facility: Research Center of Fresno
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Pacific Research Network, LLC
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine
state: California
city: Santa Ana
country: United States
facility: CITrials
state: California
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Empirical Research Group
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group
state: Florida
city: Miami
country: United States
facility: LLC Medical Research
state: Florida
city: Orange City
country: United States
facility: Avail Clinical Research
state: Florida
city: Plantation
country: United States
facility: Private Practice
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research
state: Georgia
city: Snellville
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center
state: Indiana
city: Edgewood
country: United States
facility: Otrimed Clinical Research
state: Kentucky
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Wheaton
country: United States
facility: Center for Rheumatology and Bone
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Jubilee Clinical Research
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Winston-Salem
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group- Springdale
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Center for Providence Health Partners
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Eugene
country: United States
facility: Williamette Valley Clinical Studies
state: Oregon
city: Smithfield
country: United States
facility: Frontier Clinical Research, Inc.
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Houston
country: United States
facility: HD Research Corp
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Plano
country: United States
facility: ClinRX Research Joseph, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
Study officials:
References: