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Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Jun 30, 2025 → Aug 31, 2027
See other at-risk trials from Karolinska Institutet

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 30, 2025 to Aug 31, 2027
    • Enrollment increased: 50 → 100 participants
    • Start date: Sep 20, 2023 to Nov 14, 2023
    v6
  2. Minor Study description shortened, about 58 wordsv5
  3. Notable Primary endpoints: 3 to 5v4 Show 4 more changesShow less
    • Enrollment target: 40 to 50
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 630 words
    • Publications: 6 to 7
  4. Notable Primary completion date: Dec 2024 to Jun 30, 2025
    • Study completion date: Aug 2025 to Aug 31, 2027
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Sep 20, 2023
    • Study sites: 0 to 1
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to investigate the effect of botulinum toxin on neurons' plasticity in the masseter muscle in humans with and without painful myogenous temporomandibular disorders (TMDM). The main questions it aims to answer are: * does treatment with botulinum toxin alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscles of TMDM patients? * do any such changes differ between patients with local and regional TMDM? * does treatment with botulinum toxin influence pain characteristics (intensity, frequency, and sensibility) and other variables in patients with TMDM and are there correlations between significantly changed expression of biomarkers and other variables? Participants will be examined with a questionnaire, clinical examination (including quantitative sensory testing; QST), and microbiopsy sampling from one of the masseter (MM) and anterior tibialis (AT) muscles and are then randomized to treatment with botulinum toxin or control (isotonic saline). Follow-ups occur after one and three months for all patients, and six months with questionnaire, clinical examination, and collection of post-treatment microbiopsies to see if botulinum toxin alter peripheral molecular events and clinical variables.
Trial Details
NCT Number NCT05720065
Lead Sponsor Karolinska Institutet
Conditions
(from sponsor)
Temporomandibular Disorders
Related terms Myalgia, Pain, Temporomandibular Joint Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov