NCT03994640

Brief Summary

Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

June 17, 2019

Last Update Submit

June 20, 2019

Conditions

Temporomandibular DisorderMyofascial PainCannabisElectromyography

Keywords

temporomandibular disorderCannabisElectromyographyMasticatory musclesTopical application

Outcome Measures

Primary Outcomes (1)

  • Reduction of sEMG activity of masseter muscle

    Reduction in masseter muscle electromyographic activity

    14 days

Study Arms (2)

Cannabis cream

EXPERIMENTAL

Cannabis cream topical skin application in experimental group

Combination Product: Cannabis Cream

Placebo cream

PLACEBO COMPARATOR

Placebo cream topical skin application in control group

Combination Product: Placebo Cream

Interventions

Cannabis CreamCOMBINATION_PRODUCT

Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles

Also known as: Cannabis cream topical skin application
Cannabis cream
Placebo CreamCOMBINATION_PRODUCT

Topical, bilteral skin application of placebo cream with self-massage of masseter muscles

Also known as: Placeo cream topical skin application
Placebo cream

Eligibility Criteria

Age22 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient agreement to participate into the research study
  • Age ≥22 and ≤ 27
  • Good general health,
  • Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
  • Presence of all teeth (with the exception of the third molars)

You may not qualify if:

  • Cannabis cream/ placebo cream allergy
  • Hypersensitivity to substances to be used in the study
  • Skin wounds with skin surface discontinuation
  • Addiction to cannabis
  • Patients being treated with analgesic drugs and/or drugs that affect muscle function
  • Fixed or removable dental prosthesis
  • Disease or autoimmune disorder associated with generalized muscular tension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

Location

Related Publications (3)

  • Vaney C, Heinzel-Gutenbrunner M, Jobin P, Tschopp F, Gattlen B, Hagen U, Schnelle M, Reif M. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004 Aug;10(4):417-24. doi: 10.1191/1352458504ms1048oa.

    PMID: 15327040BACKGROUND

  • Koppel BS, Brust JC, Fife T, Bronstein J, Youssof S, Gronseth G, Gloss D. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders [RETIRED]: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014 Apr 29;82(17):1556-63. doi: 10.1212/WNL.0000000000000363.

    PMID: 24778283BACKGROUND

  • Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

    PMID: 24482784BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersMarijuana Abuse

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
double blind study: for patients and researchers
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups parallel study: experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 21, 2019

Study Start

January 1, 2018

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)