drugset / Trial / NCT00035815
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
Phase 3
Completed
330 enrolled
Mayo Clinic
ALS Association · collabCephalon · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.
Timeline
- Start
- 2003-06
- Primary completion
- 2007-08
- Completion
- 2007-12
Publications
- Background Howe CL, Bergstrom RA, Horazdovsky BF. Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology. 2009 Oct 13;73(15):1247; author reply 1247-8. doi: 10.1212/WNL.0b013e3181b26ae6. No abstract available.
- Results Sorenson EJ, Windbank AJ, Mandrekar JN, Bamlet WR, Appel SH, Armon C, Barkhaus PE, Bosch P, Boylan K, David WS, Feldman E, Glass J, Gutmann L, Katz J, King W, Luciano CA, McCluskey LF, Nash S, Newman DS, Pascuzzi RM, Pioro E, Sams LJ, Scelsa S, Simpson EP, Subramony SH, Tiryaki E, Thornton CA. Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology. 2008 Nov 25;71(22):1770-5. doi: 10.1212/01.wnl.0000335970.78664.36.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | mecasermin | Protein / enzyme biologic | 0.05 mg/kg | Subcutaneous |