Living Better with ME/CFS: Join Our trial

Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) affects around 1% of the population, bringing significant challenges to daily life. There is an urgent need for new, effective treatments to improve the quality of life for those affected.

If you've been living with ME/CFS symptoms for at least 6 months, and live within a 1 hour drive of Birmingham, we invite you to participate in this important trial testing a possible new treatment. We are currently only able to recruit participants who live within a 1 hour drive of Birmingham, to enable all assessments to happen at home.

During the trial, you will receive both the trial medication and a placebo, which looks like real medicine but has no active ingredients. During the trial, you will take both the trial medication and the placebo, for 2 weeks each. You will be randomly assigned to receive either the active treatment or the placebo first. Neither you nor the trial team will know your assignment.

The trial participation will take a total of 9 weeks and all in the comfort of your own home. No travel will be required.

Participants will receive compensation up to £200.

Please contact us at remedi@lindushealth.com if you have any questions.

Your involvement could help pave the way for new, targeted treatments.

Sponsored by

Patrocinado por

Gesponsert von

Gesponsert von

Opdrachtgever:

Alfred E. Tiefenbacher GmbH & Co.KG

Participants

Participantes

Teilnehmenden

Deelnemers:

25

People

Personen

Participate by

Participar mediante

Abschlussdatum

Uiterlijke Inschrijving:

Who is the study for? 

Individuals who:

  • Are aged 18 - 60 years old
  • Live within a 1 hour drive of Birmingham
  • Have experienced symptoms of ME/CFS for 6 months or more with a defined start date (not lifelong).
  • Do not have a history of epilepsy, seizures, uncontrolled asthma, arrhythmias or prolonged QT interval.

What is expected of me? 

Here’s a step by step guide on what to expect:

1. Pre-Screening Survey Online

  • Begin by filling out a short survey on this website to determine if you are potentially eligible for the trial. 

2. Video or Telephone Informed Consent Call with the Trial Team

  • If you are potentially eligible, you will be invited to attend a pre-screening call with our trial team. During this call, we will provide more details about the trial, including information on the new medication being tested. You will also have the opportunity to ask any questions you may have and provide your consent to participate.

3. Eligibility Assessments

  • Complete questionnaires and screening assessments at home guided by the trial team. This will include assessment of your symptoms and medical history during a call with a trial doctor.

4. Recovery Period and First Baseline Period

  • Once all of the eligibility assessments are complete you will be given time to rest during a recovery period of about 1 week. At the end of this week, if you remain PEM-free, you will be enrolled into the trial.
  • You will then start the first baseline period during which you will be assigned to receive either the trial medication or placebo first. 

5. Treatment Phases

  • First Treatment Period: You will take the assigned treatment for 14 days. The dose may be increased in the second week. The trial team will let you know how much of the medication to take. 
  • Interim Period: After the first period, there will be a 14 day break from trial medication, including a second 7-day baseline period. If you experience Post-Exertional Malaise (PEM), you will get an extra 7 days to recover. 
  • Second Treatment Period: You will switch treatments, receiving whichever you did not take in the first treatment period, for another 14 days. The dose may be increased in the second week. The trial team will let you know how much of the medication to take. 

6. Follow-Up:

  • After completing both treatment periods, you will enter a 1 week follow-up period where we will monitor your safety and overall health. 

7. Ongoing Surveys plus use of a GripAble device, Oura ring and smartphone apps:

  • Throughout the trial, you will be asked to complete daily/weekly online surveys. You will also be given an Oura ring to wear 24/7, starting in the first baseline period, as well as a GripAble device for handgrip strength testing. 

What is the benefit for me?

  • Taking part in this trial may not have any direct benefit to you but you may help to further research into new treatments for ME/CFS.
  • You will receive compensation for taking part in this trial, up to the amount of £200

Living Better with ME/CFS: Join Our trial

Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) affects around 1% of the population, bringing significant challenges to daily life. There is an urgent need for new, effective treatments to improve the quality of life for those affected.

If you've been living with ME/CFS symptoms for at least 6 months, and live within a 1 hour drive of Birmingham, we invite you to participate in this important trial testing a possible new treatment. We are currently only able to recruit participants who live within a 1 hour drive of Birmingham, to enable all assessments to happen at home.

During the trial, you will receive both the trial medication and a placebo, which looks like real medicine but has no active ingredients. During the trial, you will take both the trial medication and the placebo, for 2 weeks each. You will be randomly assigned to receive either the active treatment or the placebo first. Neither you nor the trial team will know your assignment.

The trial participation will take a total of 9 weeks and all in the comfort of your own home. No travel will be required.

Participants will receive compensation up to £200.

Please contact us at remedi@lindushealth.com if you have any questions.

Your involvement could help pave the way for new, targeted treatments.

Click here to take part
Haga clic aquí para participar
Teilnehmen
Klik hier om deel te nemen

Study for

Estudio dirigido a

Zielgrupper der Studie

Onderzoek voor:

Individuals who have experienced ME/CFS symptoms for a minimum of 6 months since onset, and who live within a 1 hour drive of Birmingham

Sponsored by

Patrocinado por

Gesponsert von

Opdrachtgever:

Alfred E. Tiefenbacher GmbH & Co.KG

Participants

Participantes

Teilnehmenden

Deelnemers:

25

People

Personen

Participate by

Participar mediante

Abschlussdatum

Duur van onderzoek:

Who is the study for? 

¿A quién va dirigido el estudio?

Für wen ist die Studie geeignet?

Voor wie is het onderzoek bedoeld?

Individuals who:

  • Are aged 18 - 60 years old
  • Live within a 1 hour drive of Birmingham
  • Have experienced symptoms of ME/CFS for 6 months or more with a defined start date (not lifelong).
  • Do not have a history of epilepsy, seizures, uncontrolled asthma, arrhythmias or prolonged QT interval.

What is expected of me? 

¿Qué se espera de mí?

Was wird von mir erwartet?

Wat wordt van mij verwacht?

Here’s a step by step guide on what to expect:

1. Pre-Screening Survey Online

  • Begin by filling out a short survey on this website to determine if you are potentially eligible for the trial. 

2. Video or Telephone Informed Consent Call with the Trial Team

  • If you are potentially eligible, you will be invited to attend a pre-screening call with our trial team. During this call, we will provide more details about the trial, including information on the new medication being tested. You will also have the opportunity to ask any questions you may have and provide your consent to participate.

3. Eligibility Assessments

  • Complete questionnaires and screening assessments at home guided by the trial team. This will include assessment of your symptoms and medical history during a call with a trial doctor.

4. Recovery Period and First Baseline Period

  • Once all of the eligibility assessments are complete you will be given time to rest during a recovery period of about 1 week. At the end of this week, if you remain PEM-free, you will be enrolled into the trial.
  • You will then start the first baseline period during which you will be assigned to receive either the trial medication or placebo first. 

5. Treatment Phases

  • First Treatment Period: You will take the assigned treatment for 14 days. The dose may be increased in the second week. The trial team will let you know how much of the medication to take. 
  • Interim Period: After the first period, there will be a 14 day break from trial medication, including a second 7-day baseline period. If you experience Post-Exertional Malaise (PEM), you will get an extra 7 days to recover. 
  • Second Treatment Period: You will switch treatments, receiving whichever you did not take in the first treatment period, for another 14 days. The dose may be increased in the second week. The trial team will let you know how much of the medication to take. 

6. Follow-Up:

  • After completing both treatment periods, you will enter a 1 week follow-up period where we will monitor your safety and overall health. 

7. Ongoing Surveys plus use of a GripAble device, Oura ring and smartphone apps:

  • Throughout the trial, you will be asked to complete daily/weekly online surveys. You will also be given an Oura ring to wear 24/7, starting in the first baseline period, as well as a GripAble device for handgrip strength testing. 
Contact our study team

What is the benefit for me?

¿En qué me beneficia?

Welchen Nutzen habe ich davon?

Wat is het voordeel voor mij?

  • Taking part in this trial may not have any direct benefit to you but you may help to further research into new treatments for ME/CFS.
  • You will receive compensation for taking part in this trial, up to the amount of £200

Complete this questionnaire to take part.

Fülle diesen Fragebogen aus, um herauszufinden, ob Du berechtigt bist