Jo - Interview 32

Age at interview: 28

Brief Outline: Jo's son experiences severe migraines. In 2009 she was invited to enroll her son in a randomised placebo controlled trial for the treatment of migraine in children. Jo gave her consent although she was initially concerned about the trial and the treatment.

Background: Jo is aged 28 years, married and is a full time housewife. Jo has two children. Her eldest son is 8 years old and was diagnosed with having migraines aged 6.

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 Jo is aged 28 years, married and is a full time housewife. Jo has two children. Her eldest son Daniel is aged 8 years and has experienced severe headaches since he was two years old. He would often scream at night. At the time Jo thought this was nightmares. As he got older he would complain of severe ‘bellyache’ and was ‘sick for hours on end’. Jo took her son to the doctors and it was first thought that Daniel might be experiencing some sort of food allergy. She was advised to give him Calpol. Dan was experiencing at least one migraine a month and was unable to move, eat and drink for at least 24 hours. Eventually at the age of seven Daniel was referred to the hospital. Again she was advised to give her son Calpol. However, Jo was not happy as he was getting worse. After a second appointment at the hospital she received a call the following day to see if she would be interested to enroll her son in randomised placebo controlled trial. At the time they were very skeptical of putting him in a trial testing medication that they didn’t know and didn’t know what the side effects could be.

 

Jo and her husband agreed to meet the doctor and nurses at the hospital to get an idea of what the trial was about. Jo says she wanted to know “If it could help him, how long he’d be on the tablets for, what would happen after the trail finished, would he then have specialist help?” Her main concern was her family history of migraine as she knew how migraine could affect someone and she did not want this for her son. Making the decision was not easy. However, the doctor and nurses were very understanding and explained everything to them and how important it was to find a treatment that suited Daniel. She says “They made Daniel feel special.” It was this approach that swayed them to agree to enroll Daniel in the trial in the hope that it would help him and others.

 

Neither Jo nor the doctors and nurses know whether Daniel has received a drug or a placebo. Daniel is still in the trial. Jo is pleased to have enrolled her son as he seems to be better and has had fewer migraines. Her only concern is that Daniel has to remain on medication for the rest of his life. One thing that Jo did find hard during the trial was remembering to remind her son to take the tablets. Based on her experience and how supportive the doctors and nurses have been she would certainly consider taking part in another clinical trial in the future.

 

Jo remembers the information being in ‘lay mans' terms; however it was still daunting when there...

 The information they gave us at the start, it was more leaflets and stuff that obviously you, you read through from front to back, but as a non-medical person you’re never really going to understand them, even though they’re probably put in layman’s terms as, as much as they could, they, they can be. Obviously the, the list of side effects is scary on the, the drugs that are. But the list of side effects on paracetamol could be scary as well, and you have to look at it like that. It, it’s just difficult, I think, to choose to put a child on, on a medical trial.

Which bits do you think you didn’t understand well? Was it about the drugs?

 

No, I think, I don’t know. It’s just obviously, with migraines it’s not a condition that can, it’s a condition that can either stay with you throughout your life or it’s a condition that you can grow out of as you get older. I think we’re more, you don’t, there’s a lot of ‘don’t knows’ regarding migraines. And poor Dan is so poorly with them that, I don’t know. I just, it’s a little bit. 

 

Jo's son felt special when the nurse came to visit him at home. He was happy to take part and...

 And I think when we sat down and explained it to Dan, one of the, one of the reasons we used or explained to him as a child would be that, “If you do this and, and other children do this, then in a couple of years’ time maybe, maybe little boys and girls won’t have to suffer with headaches like you’ve done.” So that’s how we explained it to him and that’s probably how I’d explain it to somebody else who asked, “Why would you choose to put him on a trial?” 

 

Yes, he was. Dan, Dan, bless him, he’s so brave when, when he has a migraine and he’s sick for such a long time. It’s normally around eight hours, constantly. Probably around every twenty minutes to half an hour he’s sick, for around eight hours. He can’t eat, he can’t drink. He barely manages to keep his eyes open in between being sick. And he wouldn’t’t wish it on anybody. So by explaining to him that, you know, “You’re going to help other people if this trial’s successful” he was like, “All right, that’s fine.” Because children are like that, aren’t’t they? 

 

No, we, we explained, in the beginning we explained to him exactly what, what was going to happen and that he’d take tablets every day in the hope that he wouldn’t be, with Dan we explained, you see, he’s sick more than his head hurts, if that makes sense. He’s still at an age where it’s not progressed from a bellyache to a full-blown headache. He still gets extremely bad bellyache as well as the headache, so we’re in like a transition period with him. So we just explained to him that, “By doing this, you know, there’s a chance that you won’t get the bellyache and the headache as much, and that you’ll stop other, other children from having to go through it as well.” And Dan, being Dan, was more than happy with that explanation.

 

Jo was worried that it was the first trial in children of a drug used to treat migraine, but she...

So when he got to about, I think he was about 7, we took him again to the doctor’s and they finally referred him to the hospital and said, “Obviously it’s more than just your average headaches.” We took him to the hospital, that had just opened a new department, took him in to see one of the, the under, the younger doctors in there. They, they basically said at his, at his age there’s nothing they can do, “Try giving him Calpol.” Again we were like, but our concern was it was getting worse to the point where he wasn’t just sick for a couple of hours now; it was twenty-four hours. And he, he also had eye problems, so he was already under the hospital for that. The doctor sent us away with, and said, “Come back in three months’ time and we’ll assess him again.” And then the day after that appointment we got a phone call from the same doctor saying that, who is Dan’s trial doctor, was interested in meeting him. He wanted to, us to go back to the hospital. Would we be interested in a trial for medication as a preventative rather than….

 

At the time we were very sceptical of putting him on a trial. He was only; I think he’d just turned 8. Might even have been younger, he might have been 7 at the time. And it was like, “Is it really something we want to do? Put him on a trial for medication that we don’t know what it is and we don’t know what the side effects are?” Also he was due to have an operation on his eye at the same time. But we agreed to go and meet the Doctor and the nurses just to, to get an idea of basically what it was that the trial was about. If it could help him, how long he’d be on the tablets for, what would happen after the trial finished, would he then have specialist help? I think my main concern was because of my brother, so it is a family thing, my brother had migraines. Started off when he was a young child like Dan and now when he has one they last over a week and he can’t get out of bed for a week. And I think in the back of my mind that was always, “I don’t want that for Dan. I don’t want him to be unable to do things because of something that maybe we could have prevented or helped.” But it, it was a big choice to even just go along really and meet them. Because putting yourself on a medical trial is one thing, but choosing to put a child on one is a bit different.

 

So when this trial, so when we were approached for the trial and they were like, there were these drugs, and I was like, “Well, why weren’t we offered them before if they’re there?” To which they said, “Well, we only use them on adults.” And I was like, “But are they safe to use on children?” And they said, “Yes.” I think it was just more a case of Dan was having them quite frequently, they were taking him away from school, they were making him really poorly, we had his eye operations on top of it all, and we, I think we felt that being part of the trial, if he was on the drugs and they worked, it might give him a break for a little while. But in, in the end I think it was down to the fact that his doctor and his nurse were so reassuring. That they’re the reason I think that we did agree to go on it. And it wasn’t a pressure. There was no pressure in it. They agreed that, well, they were going to take care of Dan regardless of whether or not he was on the trial. And it was nice to have a specialist doctor that was willing, whether Dan wanted to be on the trial. They gave Daniel the choice as well. They explained it to Daniel and sat him down and talked to Dan about it. We’d already done it but, you know, but not a lot of doctors do that, in all fairness, treat a child as their patient. They always speak to the parents. We’ve had that a lot before in the past. So they made him reassured, which made us reassured. I think that’s probably why we chose to in the end. And plus the fact that it wasn’t a set-in-stone thing, and if we weren’t happy we could just pull out, but we could pull out and still have their support. So I think that’s, that made us decide that, that was for the best.

Knowing that the drugs had been tested and used successfully in adults helped to put Jo's mind at...

 What reassured you to take part?

 

I think I was more nervous, like I say, about, about him being a number who was on a trial and they needed so many children to be on this trial. It was the first trial that had ever been done for children. There’s been adult trials on migraines, but never about children. And that was more like a, “Oh, it’s never been done before.” So, you know, I think the other thing that scared me was every time we went to the doctor’s and said, you know, “He’s really poorly” and they said, “There’s nothing we can do.” 

 

Yes. But I think this trial was made easier for me to put him on because the tablets had been used on adults. I have to admit if they were tablets that maybe hadn’t been used at all; I wouldn’t have agreed to put him on it. But because they were something that, that was, had been used on adults for such a long time, it’s different than putting him on a new to the market drug. And I think that was also a very big factor in that, you know, children’s bodies, they are smaller, but in, in fairness they do run the same as we do. And I, I don’t think I’d have put him on a tablet, if I’m honest, that hadn’t been tried before.

 

And I think most of the drugs for children are trialed somewhere.

 

Yes, I think, I think that makes a big difference in especially, like I said, children’s trials. If you’re, if you’re an adult and you’re consenting to take a drug that’s never been put on the market, then that’s your choice to do so. But to choose to put Dan on something that hadn’t been tried on humans before, no, I don’t think I could have done that, regardless of the outcome. I think I’d have been 90 per cent more sceptical of putting him on a tablet that hadn’t been used than putting him on one that worked for adults. So I think that was, we were happy for that.

 

And they were all explained anyway, that they were tested already?

 

Yes, they were, they were well-used drugs. Both of the drugs that were in the trial were well-used drugs on adults. They just had never been used, and they, they, they had been used on children quite successfully, but there’d never been a trial to prove that they were successful. And that, that was, I think that was the major difference between putting him on a trial like the one he was on and putting him on a new drug. Which I wouldn’t have done. Because I wouldn’t, I, I think clinical trial; I guess a lot of people would put it down to feeling like a guinea pig. But that, that wasn’t how Dan was made to feel on this. So we were quite happy with everything that went on.

 

Jo found reminding her son to take his medication morning and night every day for six months...

 The, like, the other thing, and it, it’s daft, but it’s so hard to remember to do something twice a day every day. It is really difficult. I mean there’s, there’s, obviously there’s me and there’s Dan and there’s his dad, and some days we, you just, you just completely forget and you, even though you’ve been doing it for weeks and weeks and weeks. I think you; also you only fill in the diary at the end. So you only have four weeks to fill in the diary at the end. And even filling in the diary we were, some days I’d be like, “Oh, I’ll have to go back three days and make sure I’ve ticked my ticks.” And there’s not, honestly, even just a little beeper that went off at 8 o’clock in the morning and 8 o’clock at night, something that, that… You know, maybe if I’d have set my phone to beep at me or something like that would have been better than just, we did have a checklist as well that we put on the fridge, but because it was on the fridge every day it just got ignored as well. And that, that’s, honestly, that was the worst thing about it for us. And I don’t mean worst thing as in it was time consuming, I just mean that it was, trying to remember every single day, it was a lot more difficult than we anticipated it would be.

 

We are a little bit sceptical now about what the future is going to hold for him. We didn’t really want to put him on tablets daily. That wasn’t the aim we were after. But it, it did seem to, to work for the majority of the time. But it’s a lot to ask a child, to take that kind of medication every day. And remembering to take it every day is not easy. Regardless of the, the books that you get given and the check sheets, it’s still really difficult to, to remember. He reminded me more than I reminded him. They, we could do with like a beeper, you could do with a beeper of some kind, you know, to go off in the morning and at night when you’re supposed to take them. Because a lot of times it was like, “Oh.” [Forgot?] “Damn, yes, forgot.” But apart from that, 90 per cent of the time I think we remembered. But it was, I think, harder work than we expected, if I’m honest.

 

Her son coped really well with taking his medication every day.

 And did Dan mind at all, doing that every day?

 

Dan did, Dan, Dan, come the end of it, Dan was the one that was like, “Shall I get my tablets before I brush my teeth?” And we were like, “Yes, do that.” He, he was very good. If, if we forgot, he was generally the one that reminded us. But, as I say, the thing was him remembering to go up and down. That, that’s obviously my responsibility. You know, “It’s time to only take two now, Dan” or, “It’s time to only take one now.” So I was hands up, the culprit for that one. But Dan, Dan felt, I think he felt quite special. I don’t know whether, that’s, I think that’s how I’d describe it. I think he felt very much, whenever we go to the hospital, he, he gets excited to go. [Does he?] Yes. Well, we had, we’ve had so long of having appointments for his eyes where he’s been sat in a waiting room and we’ve been there for hours on end waiting for a doctor to tell us, you know, to go back and come back again. Whereas it seemed like Dan was the only one they were there for, and he was, he was made to feel extremely special. And they gave him little teddy bears, which he called [Doctor name], his little teddy bear. He named him after his doctor. And he’d take him whenever we’d go back. So, yes, he, they, he was, he felt quite special with it all, I think. And he got quite good at remembering to take them.

 

I was going to say how did he feel about going through the whole thing? But he was made to feel special?

 

Yes, he was made, yes, he was fine with it. He was absolutely fine with it.

 

The nurses came to the house with Jo's son's tablets, otherwise travelling to and from the...

 It, do you know what? I think it would have been a lot more. The hospital is quite a distance from, from where we live and it’s, it’s not been open long, so it’s in the centre of town which is quite hard to get to, especially when you have a baby that you have to drag with you as well. I think it would have been extremely difficult to get back and forth to the hospital. But because Daniel had such a good team of doctors and nurses they came here. Apart from his original, his original one, they didn’t, we went to them. And that’s where they did all his height and his weight. And then the second one, which is when we went to get his tablets, that was like visit three, we went there. But they came to the house for the other visits, to bring him his tablets and to take his empty bottles away. So, rather than having to trek, which is, and it’s a good hour drive. It probably wouldn’t be with traffic, you’re probably looking at about 25 minutes without traffic. But there’s always traffic in town. So it’s a good hour drive, and then to find parking and, it’s, it’s quite a good few hours trek round, all round. But they came here for most of it, apart from his begin-, the beginning and the end. So, and they, they phoned as well, to check on him. So they, they made it a lot more easy than what I would have thought it would have been if we would have had to do his checks at the hospital. 

Jo rang the doctors on two occasions about possible side effects and received an immediate response.

 Within a couple of weeks of him being on the drugs we noticed a change in Dan, and it wasn’t for the better. He, migraines, he wasn’t having any migraines, but his moods had changed. And we were a little bit, we couldn’t, Dan had changed schools at the same time, so we weren’t sure whether to put it down to the fact that he’d changed schools or whether he was getting older or whether it was the drugs. So I literally just sent a text to his nurse, saying, “Unsure". Dan seems a little bit moody.” And within twenty minutes we got a phone call. A couple of hours later Dan’s doctor rang to say, “We’ll drop his tablets down a little bit”. 

 

He can stay on the trial but we’ll drop him down a little bit to see how he, he goes on that, if his moods change. Any time you want to stop, we’ll stop. We’ll, and we’ll still obviously take care of Dan. Don’t worry about that.” He, he seemed to settle out a bit when his, when the dosage was dropped a little bit. And then he, I think he had maybe two migraines in the whole of the trial. Which was really good, brilliant. And then he stopped on the 24th of December. We went to see the nurse and the Doctor on I think it was 22nd or 23rd and everything was stopped then, obviously for the eight-week gap in the trial. The only bad thing was within seven days Dan had a really bad migraine. So the week, exactly a week after he’d come off the tablets, and he was just out of it for the full day. And we just felt like, “Does this mean we’re going to have to put him on tablets for the rest of his life? Do we know what?” It was a little bit like, I don’t know, we felt uneasy. So next day I texted his nurse, explaining that obviously Dan had a migraine. I wasn’t sure if she was on Christmas break. And within ten minutes I had a phone call back off his other nurse. And then the day after that the Doctor rang us as well to see how he was getting on, how he was feeling, “Anything else, just ring back again” and they’d sort him out. They were absolutely brilliant. 

 

Jo's son is taking part in a randomised placebo controlled trial of a drug for migraine in...

 Well, as far, as far as I know the purpose of the trial was, they explained to us that there, there had never been a trial done on children for migraine. There wasn’t really anything out there as, as we’ve learnt along the way of, “Just give him Calpol. Give him Brufen.” And our problem with Daniel is he can’t keep water down for twelve hours, so he can’t keep drugs down. So it, that, that was, there, there was nothing, there’s nothing really out there for, for children that’s used as a, as a wide range. And a lot of kids do suffer from it as, as, even though it’s not a common thing. I think they said 1 in 30, to which Dan said, “Oh, that’s one in every class”, which is right. That’s a lot of children.

 

Yes, we, I know that placebo means just, it could be candy for anything, it could be sweets. It does, it just, it, if sometimes the brain thinks it’s getting help then the body heals itself. Some people believe that. The other two drugs that were on it were, were, we were assured that they, they were well-used drugs. The trial in itself, we, we’d been through a lot with Dan’s migraines and there was no one, there was never any solution or never anyone there to help. 

 

At the beginning of the trial Jo's son showed signs of mood swings. She immediately told the...

 I think it’s, it’s a constant worry as well. You’ve put them on something you don’t really. I know you can read up on the leaflets and stuff, but you don’t know what they’re on. So when, like when Dan started having mood swings we didn’t know whether it, we don’t know if he, he was, if he was on a placebo or not. We still don’t know that. We won’t know for eight weeks, for another eight weeks. 

 

But I think that’s, obviously it’s part of the trial and you have to not know, but it made it difficult if he was ill or, like I say, when he was moody and he was very lethargic. And Dan’s not like that. He’s a rugby player and he’s very… So for the first, when he was on the high dosage of the tablets for the first six weeks, he was, wasn’t his normal self and it was a little bit worrying. But we didn’t know what to, what was contributing to it. So, I don’t know, it was just a little bit of a tense time for everybody, I think. And also hoping that it would work. And then we were a little bit, I felt a little bit dismayed because we were hoping… the Doctor described it as a good phase. Dan was in a good phase when he came off the tablets because he hadn’t had a migraine in, in a month. And as soon as he came off them, for him to have a full-blown one where he was pretty much out of it for two days, and it was a little bit, I think, disheartening for everybody. That it kind of hit home that maybe if he was on something, which it seemed, you know, he may have been, that he’s going to end up taking tablets until an unspecified date. So it’s a bit, a bit much.

 

Yes, we, I know, I know that placebo means just, it could be candy for anything, it could be sweets. It does, it just if sometimes the brain thinks it’s getting help, then the body heals itself. Some people believe that. The other two drugs that were on it were, we were assured that they, they were well-used drugs. The trial in itself, we’d been through a lot with Dan’s migraines and there was no one, there was never any solution or never anyone there to help. And I think when we sat down and explained it to Dan, one of the, one of the reasons we used or explained to him as a child would be that, “If you do this and, and other children do this, then in a couple of years’ time maybe, maybe little boys and girls won’t have to suffer with headaches like you’ve done.”  [um] So that’s how we explained it to him and that’s probably how I’d explain it to, to somebody else who asked, “Why would you choose to put him on a trial?”  

 

I know for definite that Dan’s, the nurses and the doctor didn’t know what he was on. They still don’t know what he’s on now. I think that probably made it difficult for them as well in the fact that when I rang up to tell them that Dan’s moods seemed to have changed and we weren’t sure whether it was because he’d changed schools or because of his age or because, and of course they don’t know whether he’s on something or not. So I don’t know whether, if he hadn’t have, I think that they don’t know because if he hadn’t have been on something, and if he’d been on the placebo, they would have said, “No, we, no, we’ll just leave him on that. It’ll be fine.” And maybe I would have known that he wasn’t. I don’t know. I can’t, it’s not my field to say whether or not the doctors and nurses should know what he’s on. They, but they seem to have coped fine with not, with not knowing what he was on. 

 

As the trial has gone on, Jo would now be surprised if her son had been given the placebo, but...

 I’ve been grateful for the help that we got off the nurses and doctors, and we’ve been reassured it will continue anyway and, plus the fact that the trial is being done so that they’re, they’re trying to, they are trying to find the best drug all round for children. So regardless of whether or not he was on a tablet in the first place, he may be put on one if they feel that that’s the best. And then they’ll monitor him. And we know that they’re going to make sure that they find what’s right for Dan. But I don’t know. I think it would be strange if he’d been on it, if I’m honest. I think I’d be quite shocked at this point, if he’d been on it. Especially, at first we were very unsure whether or not he was on it. His migraines were a lot less than they, than they normally were. But for him to have one in such close proximity to him coming off the tablets, I think would be quite a shock. But it’s a possibility, and if it is it means that he had a really good six months. So we’ve, you know, we only had three migraines in six months. Which is really good. So either way there’s no losing, I don’t think, in this situation. He may be, he may have been on one of the drugs, but the other one still may suit him better. You don’t know what the trial is going to, it may show. You don’t know which one is going to come out on top, if either of them.