NCT04530955 - 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)

Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF
Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003 Feb;98(2):291-5.
Bohannon RW, Smith MB
Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP
Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006 Nov;87(11):1509-15.
Lewis KS, Mueller WM
Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. Review.
Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R
Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg
Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL
Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002 Jan;5(1):16-24. doi: 10.1046/j.1525-1403.2002._2004.x.
Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL
Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation. 2016 Aug;19(6):607-15. doi: 10.1111/ner.12447. Epub 2016 Jul 19. Review.

Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.

Details for clinical trial NCT04530955

Clinical trial NCT04530955 - References