NCT03223298 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Botulinum Toxin A for Myofascial Pain Syndrome: A Review of the Clinical Effectiveness [Internet]
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Sep 22. Available from http://www.ncbi.nlm.nih.gov/books/NBK253364/
Freund B, Schwartz M, Symington JM
Botulinum toxin: new treatment for temporomandibular disorders. Br J Oral Maxillofac Surg. 2000 Oct;38(5):466-71. doi: 10.1054/bjom.1999.0238.
Freund B, Schwartz M, Symington JM
The use of botulinum toxin for the treatment of temporomandibular disorders: preliminary findings. J Oral Maxillofac Surg. 1999 Aug;57(8):916-20; discussion 920-1. doi: 10.1016/s0278-2391(99)90007-1.
Guarda-Nardini L, Stecco A, Stecco C, Masiero S, Manfredini D
Myofascial pain of the jaw muscles: comparison of short-term effectiveness of botulinum toxin injections and fascial manipulation technique. Cranio. 2012 Apr;30(2):95-102. doi: 10.1179/crn.2012.014.
Soares A, Andriolo RB, Atallah AN, da Silva EM
Botulinum toxin for myofascial pain syndromes in adults. Cochrane Database Syst Rev. 2014 Jul 25;2014(7):CD007533. doi: 10.1002/14651858.CD007533.pub3.
von Lindern JJ, Niederhagen B, Berge S, Appel T
Type A botulinum toxin in the treatment of chronic facial pain associated with masticatory hyperactivity. J Oral Maxillofac Surg. 2003 Jul;61(7):774-8. doi: 10.1016/s0278-2391(03)00153-8.

Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial

Details for clinical trial NCT03223298

Clinical trial NCT03223298 - References