NCT05615987 - 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)

Childers MK, Kornegay JN, Aoki R, Otaviani L, Bogan DJ, Petroski G
Evaluating motor end-plate-targeted injections of botulinum toxin type A in a canine model. Muscle Nerve. 1998 May;21(5):653-5.
Kaymak B, Kara M, Tok F, Ulasli AM, Öztürk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Özçakar L
Sonographic guide for botulinum toxin injections of the lower limb: EUROMUSCULUS/USPRM spasticity approach. Eur J Phys Rehabil Med. 2018 Jun;54(3):486-498. doi: 10.23736/S1973-9087.17.04667-6. Epub 2017 Apr 4. Review.
Kim MW, Kim JH, Yang YJ, Ko YJ
Anatomic localization of motor points in gastrocnemius and soleus muscles. Am J Phys Med Rehabil. 2005 Sep;84(9):680-3.
Prodanov D, Nagelkerke N, Marani E
Spatial clustering analysis in neuroanatomy: applications of different approaches to motor nerve fiber distribution. J Neurosci Methods. 2007 Feb 15;160(1):93-108. Epub 2006 Oct 17.
Prodanov D, Thil MA, Marani E, Delbeke J, Holsheimer J
Three-dimensional topography of the motor endplates of the rat gastrocnemius muscle. Muscle Nerve. 2005 Sep;32(3):292-302.
Shaari CM, Sanders I
Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9.

Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.

Details for clinical trial NCT05615987

Clinical trial NCT05615987 - References