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64000-00120 Rev 3
19. CLINICAL STUDIES
Acute cluster headache clinical studies
Clinical data demonstrating the safety and effectiveness of gammaCore for the acute treatment
of episodic cluster headache is presented from two prospective, double-blind, sham-controlled,
randomized clinical trials (The ACT1 and ACT2 Studies).
Summary
In both studies, gammaCore did not provide a significant improvement over a sham (placebo) device in
the total patient population, which included patients with episodic cluster headache (eCH) and chronic
cluster headache (cCH). In both studies, there was a significant improvement over sham demonstrated
in patients with eCH but not cCH, which affected the results in the total study population.
Study 1: gammaCore for the acute treatment of episodic cluster headache: The ACT1 Study
In the ACT1 Study, subjects were instructed to treat their cluster headache attack at the onset of pain
with three 2-minute stimulations (Figure 3).
Figure 3. ACT1 Treatment Protocol
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