Lucinda - Interview 33

Age at interview: 37

Brief Outline: Lucinda's son was diagnosed with migraine at the age of 6 and in 2010 she was invited to enroll her son in a double blind randomised placebo controlled trial on the treatment of migraine in children.

Background: Lucinda, aged 37 years, is a single mother to her son Toby aged 10 years. Lucinda describes herself as White British as works fulltime in the legal profession.

More about me...

 Lucinda, aged 37 years, is a single mother to her son Toby aged 10 years. Lucinda describes herself as White British as works fulltime in the legal profession. Toby was diagnosed with migraine at the age of six and in 2010 Lucinda was invited to enroll her son in a double blind randomised placebo controlled trial on the treatment of migraine in children.

 

Lucinda has been very pleased with the support of the Research Nurse and the doctors treating Toby and says they have answered all her questions. Importantly, Lucinda says they have put my son’s health first and have answered any questions he asked and made him feel very at ease. This has been a huge factor in deciding to enroll her son in the trial along with being assured that the drug has been tested and is used in adults and children for the treatment of migraine. However, this is the first time the treatment has been tested in children.

 

It has been important to Lucinda to involve her son in making the decision to take part and if at any time he wants to stop the trial she would respect this. Although Lucinda signed the parent consent form and had information about the trial, Toby had his own pack of information and signed an assent form to say he was happy to take part. The doctors and nurses involved Toby from the beginning and made sure that he understood what was expected of him.

 

Toby has to take tablets everyday during the trial, but because it is a double blind placebo controlled trial neither the doctors or nurses know which drug Toby is taking. 

 

Toby and Lucinda both hope that taking part will help the researchers to find the best treatment for Toby and for other children who have migraine.

 

Lucinda explains that although the drugs are already used to treat migraine in adults, this is...

 Well, it, it has, it, it, the, both the drugs that are being trialed are currently used for childhood migraine, but they’d never done a study. And it can also, they’ve, they’ve linked, see, the other side that didn’t want me to do it, childhood migraine they’ve found is linked to epilepsy. So treatments that are given for migraine are actually also used for epilepsy in children. Which, the symptoms are slurred speech, slowness, and I didn’t want him to fall behind in school. And that’s why initially I said no to medication in 2008. But I think because they got so severe, so I don’t really think we had much choice. We had to try something. Toby was going to be put on one of these medications anyway, so we thought, “May as well go ahead with the trial.” If they can get more feedback from parents and children, anything can help.

 

I think I’d, I’d just say that the medication is currently in use anyway. They just want to see how effective it is. The placebo isn’t a medication. But the only way that they can get anywhere is to research it. Throw the placebo in as well to see if it makes any difference. Because a lot of things psychologically, I think, pop a pill in, I think you feel better. But, yes, basically just that. It’s, I don’t think it’s a, a, a major thing, putting forward yourself or your child for a trial if the medication is already in use. It’s just collecting data. But I think its data that needs collecting just so they can help people in the future.

 

Anything to help prevent other children from having migraines was one of the reasons Lucinda and...

 And, to be honest, any data that we can give that helps look into migraine, especially with children. Because I know it’s awful for adults to suffer, but children don’t, don’t understand and they don’t understand their bodies the same. And as a parent you feel quite helpless when you see your child in so much pain. So I from my point of view, anything that helps discover anything about this, it’s a bonus, a big bonus.

 

Well, it, it has, it, the, both the drugs that are being trialled are currently used for childhood migraine, but they’d never done a study. And it can also, they’ve linked, see, the other side that didn’t want me to do it, childhood migraine they’ve found is linked to epilepsy. So treatments that are given for migraine are actually also used for epilepsy in children. Which, the symptoms are slurred speech, slowness, and I didn’t want him to fall behind in school. And that’s why initially I said no to medication in 2008. But I think because they got so severe, so I don’t really think we had much choice. We had to try something. Toby was going to be put on one of these medications anyway, so we thought, “May as well go ahead with the trial.” If they can get more feedback from parents and children, anything can help.

 

When the trial ends her Lucinda's son might feel relieved not to be taking so many tablets every...

 I think Toby will be relieved not to have to take eight tablets a day. But then maybe he’ll just go on to one tablet a day or what, whatever the dosage is for the medication. I don’t think it’ll make much difference to us, because it’s not a major thing to take medication in the morning and in the evening. I know it is for, for children. But I think because he’s got used to it and he knows that it could possibly lead to something that’s going to help him, I just don’t think it makes that much difference. Sort of two seconds out of your life, isn’t it? So, no, I don’t think it’s going to make much difference at all.

 

Yes, I think it is. I think there’s a, there doesn’t seem much point in doing a trial and then not knowing the outcome of it. You know, ta, doing something for fourteen weeks and then thinking, “Oh, right, well, that part of your life’s gone.” I think it’s nice to carry it on and see what, what comes of it.

 

When medication is involved it isn't an easy decision to make and Lucinda required lots of...

 What sort of questions did you have?

Well, I was, because you don’t know what medication Toby was going on. There were two medications that are currently being used for migraine, and the placebo. My concern wasn’t about the placebo, it was about the, the current medication that is being used, side effects and things. But they said they were minimal. I went away, looked at length myself on the Internet. I also had a word with my boss, who’s a barrister and his son is a surgeon, paediatric surgeon. So my boss had a word with his son and he came back and said, “No, it’s fine. They’re both safe. It’s not a clinical trial. They’re already in use. So it’ll be safe for Toby to go ahead.” So I was happy to do that.

 

Lucinda's son had his own information to read and an assent form to sign; he was involved in the...

 And then they spoke to my son as well. I was obviously in the same room but they weren’t directing questions to me. They were talking to him. And they asked what he thought about it. Rather than just putting him straight on medication, they explained that it would be really helpful because nobody had ever done a study on childhood migraine before, and would we like to participate? 

 

Because Toby’s 10, he can sort of make his own mind up. We discussed it, and at first he was a bit dubious about it. And I said, “If you’re going to go and get put on medication anyway, you may as well try and help them in the studies.” So we had a third appointment, where he saw the research nurse on his own. And he came out of that appointment and he was really happy to do it. So we started the research. But all the way through the communication has been fantastic. They’ve answered every question that I’ve had.

 

And you had all the, I mean was it written information that you had?

 

Yes, everything was written. They sent a copy to myself and also an easy, readable version to Toby, in child-friendly terms, which explained everything to Toby as well. So we could both understand what was being said.

 

Yes, a big part of it, a big part of it. Dr is very approachable anyway; he’s very down to earth. Doesn’t talk down to the children either. So Toby felt that he could trust him. And in the initial assessment, we were there for two hours. Which seems quite a long time, but when you’re laughing and joking and he’s making Toby do silly walk... A lot of it is to make him feel at ease, as well as checking balance and things. A lot, a lot of it is to make the child feel at ease. But the nurses were lovely as well, really pleasant, very forthcoming. You don’t feel as if there’s a barrier, you don’t feel as if they’re ‘up there’ and you’re ‘down here’ and you can’t speak to them properly. Just really approachable on all levels. So it was quite comforting actually.

 

Well, we talk about everything anyway, because we live together on our own. There’s only me and him. But this was, we do talk about things, but this was a major part of his life because he was going to be taking medication in the morning and at bedtime. So it was a big part of his life change. So we talked about it before he started the medication. I wanted him to understand that it was his responsibility when he wakes up to take the meds, when he goes to bed. And he has. He’s done it. I still check, but, yes.

 

Well, I think it’s good, like you say that he has his own information. And, and did it come, I mean was it all words or were there words and pictures?

 

No, it was, it was all words, but it was, wasn’t clinical, scientific. It was 

 

How did they explain the groups in, in, in the information that there would be…

 

Just that, they did say that like they were testing two medications and they, again they put the names of the medications, they were in bold. And then they said the placebo and they explained what the placebo was. And it just said, “You won’t know what you’re going to be on. But if you’re still happy, sign this.” And he had to sign his own consent form. So, yes, it was a big thing for him.

 

How did they explain a placebo?

 

Just that it wasn’t medication.

 

Having the reassurance that the drug was already being used in children to treat migraine was...

 So Tobias started with migraine in about 4, 5. I think he may have had about 4 but they were very severe. So we were back and forth to the GP. It wasn’t constant, so the GP just kept saying, “Well, carry on doing what you’re doing. Mess about with your medication.” In about 2008 the migraines were getting more and more severe, so we got referred to the children’s hospital, where he saw. He did full tests on Tobias and said there were several routes that we could take. He explained them all to me. The one that they were suggesting was to go on medication. Well, I wasn’t very happy about that at the time, because we looked at all the side effects and things. So we came away and I just thought, “Well, Tobias was getting used to them. He could manage them himself.” So we just plodded on and Tobias himself was happy to do that. But at the beginning of this year they were getting more and more frequent, sort of like having three a week. So they were knocking him out completely. He was missing school, activities after school which, he had to stop all his activities. So we went back to the GP. I said that we needed something doing about it, he needed looking at. So he said, “Right, okay” referred us back to Dr at the children’s hospital. We got a really quick appointment through. Then they arranged for us to have a second appointment with Dr. In the meantime they rang and said, “Would you be okay if a research nurse sat in on the appointment?” So we said, “Not a problem.” Anything at this point, because we just wanted to do something because Toby was suffering so much. So we had the second appointment. He spoke to myself at length, explained what research was going on in the hospital, what they were trying to do, who was running the research. And then they spoke to my son as well. I was obviously in the same room but they weren’t directing questions to me. They were talking to him. And they asked what he thought about it. Rather than just putting him straight on medication, they explained that it would be really helpful because nobody had ever done a study on childhood migraine before, and would we like to participate? 

 

Because Toby’s 10, he can sort of make his own mind up. We discussed it, and at first he was a bit dubious about it. And I said, “If you’re going to go and get put on medication anyway, you may as well try and help them in the studies.” So we had a third appointment, where he saw the research nurse on his own. And he came out of that appointment and he was really happy to do it. So we started the research. But all the way through the communication has been fantastic. They’ve answered every question that I’ve had.

 

Lucinda isn't required to keep a diary, but keeps a note of the dates her son has a migraine and...

 Just basically start the medication. Before he started the medication he had a four-week period where he kept a diary, logging the migraines and any auras. Since the medication started we haven’t had a diary to keep, but I’ve been keeping one for myself anyway, just so I know what dates he’s had migraine. Basically just to take his medication, which he’s very good at doing. He’s never missed any. And just monitor. If at any time I feel that his symptoms or he’s getting bad side effects, I can stop the trial immediately. And that was made very clear to me from the outset. You don’t have to take part. Not just myself. If Toby didn’t feel comfortable with it, he could stop taking medication. He’s had a few nosebleeds on the trial. And he’s had three migraines. But I think we’ve been doing it since October, October the 31st, so it’s actually, he’s done quite well considering he was having them two, three times a week. And I’m not saying that’s anything to do, it might not be. But that’s why he’s happy himself to stay on the trial. And I’m happy for, to support that.

 

If it had, if he’d have got worse or there’d been more, would you…?

 

I’d have stopped then probably, yes. And I think Toby feels the same. If, if it had had anything that would have made him feel more that he couldn’t carry on with day-to-day living activities like playing out or going to the scouts, different things, he would have stopped. Because he’s quite strong willed and he knows his own mind. But, no, he’s been, he’s been fine. And he’s happy to see it till the end of the trial. So I’ll support him in that.

 

Lucinda was worried that her son would find it hard to describe any side effects of the treatment...

 I was very nervous actually, just because it wasn’t for me. And children aren’t very good at expressing themselves anyway, not; they’re not very good at expressing feelings. So if you, if you could say to Toby, “Can you describe your migraine?” it would just be like, “Oh, well, it...” Because apparently you could have left-sided or right-sided, well, Toby’s is all over, all at the front. So, but when the doctor was asking him certain questions he was very vague in his answers, where an adult can be more specific. So I was quite nervous because I didn’t want Toby to feel as if he was under too much pressure in that he couldn’t relay back to me any side effects. And I, I was quite nervous about that. But it, it’s okay, because I don’t; I don’t think I gave him enough credit really. Because he seems to know. And if he feels a bit off he’ll tell me. Or if he looks a bit peaky I’ll say, you know, “Looking a bit grey today. Are you okay?” Because you can usually tell when a migraine is coming on. But, no, I think once I’d been told that the medication was fine I felt a lot more at ease. Because, like you say, when you don’t know what medications do anyway. 

 

In our experience, no. We’ve had support right from the start. We were told what we were going in to right from the start. I think it was really important about Toby getting his own literature as well as myself. That was a really big thing for him. No, because the, the experience we’ve had up to now, we’ve had a lot of support. We do know, and we keep being told, “If you want to withdraw, you can withdraw.” But no, we’re happy. Toby’s happy.

 

Lucinda's son was happy to stay in the trial. So far he's had no major side effects, but if he...

 Just basically start the medication. Before he started the medication he had a four-week period where he kept a diary, logging the migraines and any auras. Since the medication started we haven’t had a diary to keep, but I’ve been keeping one for myself anyway, just so I know what dates he’s had migraine. Basically just to take his medication, which he’s very good at doing. He’s never missed any. And just monitor. If at any time I feel that his symptoms or he’s getting bad side effects, I can stop the trial immediately. And that was made very clear to me from the outset. You don’t have to take part. Not just myself. If Toby didn’t feel comfortable with it, he could stop taking medication. He’s had a few nosebleeds on the trial. And he’s had three migraines. But I think we’ve been doing it since October, October the 31st, so it’s actually, he’s done quite well considering he was having them two, three times a week. And I’m not saying that’s anything to do, it might not be. But that’s why he’s happy himself to stay on the trial. And I’m happy for, to support that.

 

If it had, if he’d have got worse or there’d been more, would you?

 

I’d have stopped then probably, yes. And I think Toby feels the same. If, if it had had anything that would have made him feel more that he couldn’t carry on with day-to-day living activities like playing out or going to the scouts, different things, he would have stopped. Because he’s quite strong willed and he knows his own mind. But, no, he’s been, he’s been fine. And he’s, he’s happy to see it till the end of the trial. So I’ll support him in that.

 

Lucinda says not to be afraid to ask questions, especially if your child will be taking any...

 Just to get as much information as you can from the doctor running the trial, even if, sorry, even if they’re not running the trial. Because in our case [Doctor] isn’t running the trial, but he’s our point of contact as well as the nurses. But he has the information on the medication that you need to know. Also just to build up a good rapport with your nurses, your research nurses. Because that’s their job, that’s what they’re there for. Don’t be, don’t be afraid to ask anything. Once you’ve, once you’ve checked in your own mind that everything’s been checked and double-checked and you feel quite happy, I’d go for it. I’d tell anybody to go for research. It’s just, it’s got to help. We’ve got to progress, haven’t we? And that’s the only way we can do it. So, yes, I’d tell people to do it.

Lucinda supports research and was quite surprised that childhood migraine hadn't been researched.

Depending on what it was, yes. I don’t have a problem with research. I think it’s a really important part; it’s a major part actually in science. And I know through my own work, collecting data is just a must. So whatever can help in the future, I think. And I was quite surprised actually when we were told that childhood migraine hadn’t been researched. I think if it’s been about for as long as it has, I was, I was really quite shocked that it hadn’t. I thought it would have been a lot more advanced. But I do understand that there isn’t much they can do. Because, as we were told, as, as Dr explained to Toby, there isn’t physically anything wrong with the brain, it’s just the cells. So there isn’t much they can do.

Lucinda's son had his own information and signed his own assent form to say he was happy to take...

 Well, I think it’s good, like you say that he has his own information. And, and did it come, I mean was it all words or were there words and pictures?

 

No, it was, it was all words, but it was, wasn’t clinical, scientific. It was 

 

How did they explain the groups in the information, that there would be…?

 

Just that, they did say that like they were testing two medications and they, again they put the names of the medications, they were in bold. And then they said the placebo and they explained what the placebo was. And it just said, “You won’t know what you’re going to be on. But if you’re still happy, sign this.” And he had to sign his own consent form. So, yes, it was a big thing for him.

 

How did they explain a placebo?

 

Just that it wasn’t medication.

 

Lucinda would have been uneasy if there had been a payment for taking part.

No, because it was a voluntary thing. And I wouldn’t expect it in a child anyway. And I think I wouldn’t expect it. Because I, I’ve had friends that have done clinical trials before on medication that, that isn’t on the market, and they’ll get a one, one-off fee for spending five days in hospital. This isn’t like that. This is medication that’s already being used in treatment. If we had have been offered a payment, I wouldn’t have done the trial. 

A placebo isn't medication, although believing that it is may make patients feel better, but it...

 Yes, we don’t know what Toby’s actually trialing at the moment. We don’t know what he’s on. Obviously a placebo does nothing for you. It doesn’t help at all, but it also doesn’t hinder. So that’s why I was quite happy to go on it. But, no, we don’t know what he’s on. I can’t really tell. Because they have asked if I can tell if there’s a difference. I can’t really tell at the moment. 

 

I think I’d just say that the medication is currently in use anyway. They just want to see how effective it is. The placebo isn’t a medication. But the only way that they can get anywhere is to research it. Throw the placebo in as well to see if it makes any difference. Because a lot of things psychologically, I think, pop a pill in, I think you feel better. But, yes, basically just that. It, it’s, I don’t think it’s a major thing, putting forward yourself or your child for a trial if the medication is already in use. It’s just collecting data. But I think it’s data that needs collecting just so they can help people in the future.