NCT00384579 - 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)

Aoki KR
Pharmacology and immunology of botulinum toxin serotypes. J Neurol. 2001 Apr;248 Suppl 1:3-10. Review.
Aoki KR
Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. Epub 2005 Jul 5. Review.
Foster L, Clapp L, Erickson M, Jabbari B
Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. 2001 May 22;56(10):1290-3.
Frymoyer JW
Predicting disability from low back pain. Clin Orthop Relat Res. 1992 Jun;(279):101-9. Review.
Lew MF, Brashear A, Factor S
The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Neurology. 2000;55(12 Suppl 5):S29-35.
Rand MJ, Whaler BC
Impairment of sympathetic transmission by botulinum toxin. Nature. 1965 May 8;206(984):588-91.
Wipf JE, Deyo RA
Low back pain. Med Clin North Am. 1995 Mar;79(2):231-46. Review.

Pilot Study to Assess the Efficacy of Botulinum Toxin B (Myobloc®) Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Acute Low Back Pain

Details for clinical trial NCT00384579

Clinical trial NCT00384579 - References