AMP-516: rintatolimod in severe chronic fatigue syndrome
Strayer DR et al. · 2012 · PLOS ONE
Indexed 2026-11-12.
Reported findings and study design
Reported findings
Double-blind IV rintatolimod or saline twice weekly for 40 weeks. The active dose was 200 mg for the first two weeks, then 400 mg. The primary endpoint was treadmill exercise duration.
Dose, route and schedule
Double-blind IV rintatolimod or saline twice weekly for 40 weeks. The active dose was 200 mg for the first two weeks, then 400 mg. The primary endpoint was treadmill exercise duration.
Protocol source ↗ · Original source
| Measure | Result | Comparison, timing and statistics |
|---|---|---|
| Treadmill exercise tolerance | Mean treadmill time rose by 96 seconds with rintatolimod and 28 with placebo. The mean within-person percentage change was 21.3 percentage points greater with rintatolimod (p=0.047). | |
| Completion | 93/117 on rintatolimod and 101/117 on placebo completed the 40-week stage. |
The sponsor-funded study used historical CDC case definitions. Treadmill performance does not measure delayed post-exertional malaise or everyday function.
Source for these results ↗ · Reviewed 2026-11-12
For research and education. Consult a qualified clinician for medical advice.
Study limitations and source details
Study limitations
- The sponsor-funded study used historical CDC case definitions. Treadmill performance does not measure delayed post-exertional malaise or everyday function.
Related publications may cover the same research program or participants.
Source access
Double-blind IV rintatolimod or saline twice weekly for 40 weeks. The active dose was 200 mg for the first two weeks, then 400 mg. The primary endpoint was treadmill exercise duration.
Source reviewed 2026-11-12.
Citation and original source
Original source: Strayer DR et al.. AMP-516: rintatolimod in severe chronic fatigue syndrome PLOS ONE 2012.
Molekul research summary: https://molekul.io/research/rintatolimod-amp516-2012. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.
Bibliography entry