Trial of Galcanezumab in Prevention of Episodic Cluster Headache

[CHfather]

"The percentage of patients who had a reduction of at least 50% in headache frequency at week 3 was 71% in the galcanezumab group and 53% in the placebo group."

This might make one as curious about the power of placebo as about the efficacy of galcanezumab (Lily's CGRP drug). (Also curious about why only results for weeks 1-3 are included, since apparently it was administered again at 1 month.)

Trial of Galcanezumab in Prevention of Episodic Cluster Headache; Goadsby P, Dodick D, Leone M, Bardos J, Oakes T, Millen B, Zhou C, Dowsett S, Aurora S, Ahn A, Yang J, Conley R, Martinez J; New England Journal of Medicine (NEJM) 381 (2), 132-141 (2019)

Tags:

• calcitonin (human synthetic)
• calcitonin (pork natural)
• calcitonin (salmon synthetic)

 

BACKGROUND Episodic cluster headache is a disabling neurologic disorder that is characterized by daily headache attacks that occur over periods of weeks or months. Galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, may be a preventive treatment for cluster headache.

METHODS We enrolled patients who had at least one attack every other day, at least four total attacks, and no more than eight attacks per day during a baseline assessment, as well as a history of cluster headache periods lasting at least 6 weeks, and randomly assigned them to receive galcanezumab (at a dose of 300 mg) or placebo, administered subcutaneously at baseline and at 1 month. The primary end point was the mean change from baseline in the weekly frequency of cluster headache attacks across weeks 1 through 3 after receipt of the first dose. The key secondary end point was the percentage of patients who had a reduction from baseline of at least 50% in the weekly frequency of cluster headache attacks at week 3. Safety was also assessed.

RESULTS Recruitment was halted before the trial reached the planned sample size of 162 because too few volunteers met the eligibility criteria. Of 106 enrolled patients, 49 were randomly assigned to receive galcanezumab and 57 to receive placebo. The mean (±SD) number of cluster headache attacks per week in the baseline period was 17.8±10.1 in the galcanezumab group and 17.3±10.1 in the placebo group. The mean reduction in the weekly frequency of cluster headache attacks across weeks 1 through 3 was 8.7 attacks in the galcanezumab group, as compared with 5.2 in the placebo group (difference, 3.5 attacks per week; 95% confidence interval, 0.2 to 6.7; P = 0.04). The percentage of patients who had a reduction of at least 50% in headache frequency at week 3 was 71% in the galcanezumab group and 53% in the placebo group. There were no substantial between-group differences in the incidence of adverse events, except that 8% of the patients in the galcanezumab group had injection-site pain.

CONCLUSIONS Galcanezumab administered subcutaneously at a dose of 300 mg once monthly reduced the weekly frequency of attacks of episodic cluster headache across weeks 1 through 3 after the initial injection, as compared with placebo. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT02397473.).

https://www.docguide.com/trial-galcanezumab-prevention-episodic-cluster-headache?tsid=5

[spiny]

I don't believe I would try this drug based on a reduction of 3.5 attacks/week. Good grief, it is amazing that they would even consider this successful! With 4 hits/day, I would gain by having only 3 hits for 3 out of seven nights. Not worth spending the money in my book. I suspect that someone with only one hit every other day would call it helpful. Unfortunately, many if not most do not fall into this category.

Did they return to normal frequency at week 4? What happened? 

Thanks CHF. Good to know what is going on out there. MM still wins. 

[JokkerQ]

Can someone call CBD oil as a drug?

[Freud]

3 hours ago, JokkerQ said:

Can someone call CBD oil as a drug?

You’re best off making a new post or searching for CBD in this website to see what people’s experience has been.  It is a drug. Not so much a recreational drug like thc, but a drug none the less...

Edited July 31, 2019 by Freud

[Freud]

On 7/16/2019 at 2:09 PM, spiny said:

I don't believe I would try this drug based on a reduction of 3.5 attacks/week. Good grief, it is amazing that they would even consider this successful! With 4 hits/day, I would gain by having only 3 hits for 3 out of seven nights. Not worth spending the money in my book. I suspect that someone with only one hit every other day would call it helpful. Unfortunately, many if not most do not fall into this category.

Did they return to normal frequency at week 4? What happened? 

Thanks CHF. Good to know what is going on out there. MM still wins. 

From what brief exchange I had w BHD, it has a wide range of “help” for different patients. He’s had patients go from chronic to episodic, others that just get a reduction, some remission and yet others no relief. He thinks it’s worth trying for some one that is uncontrolled like me. However we both agreed to wait until I was fully detoxed from the invega and can say for sure if psychedelics will work for me. It’s my last option...

[Freud]

I have also been told by my pervious doc that it can take months to work. So I’m surprised they only studied it less than a month out. That placebo group is strange!