Roche to increase GENERATION HD1 enrolment
Today Roche has announced that they are increasing the total enrolment in the GENERATION HD1 study (NCT03761849) from 660 to 801 participants worldwide. The study change does not impact participants already enrolled, but it allows for additional patients to enrol in each of the three study groups.
What is the GENERATION HD1 study?
The GENERATION HD1 study evaluates the efficacy and safety of the investigational molecule RG6042 in people showing Huntington’s disease symptoms. The 25-month study is testing two dosing regimens compared to placebo - RG6042 once every two months (eight weeks) or RG6042 every four months (16 weeks). The open-label extension of the Phase I/IIa study is ongoing and supports the exploration of the two dosing groups in the GENERATION HD1 study.
Why are Roche increasing enrolment?
Roche believes that increasing enrolment now before study recruitment closes, keeps the study on track for completion within the expected timelines. Other reasons include -
- More data - The additional number of participants will provide more data to equally evaluate both dosing groups, as well as increase the statistical power of the study. In interactions with the Huntington’s community, Roche have learned the importance of testing both doses while acknowledging that less-frequent dosing wouldn’t be as demanding for patients, families and the overall healthcare system in a real-world setting.
- More confidence - Prior to GENERATION HD1, a study of this size involving investigational medicine administered via injection to the spinal cord has never been conducted in Huntington’s. Given the rate of recruitment since starting the study in the summer, Roche are confident that this larger study can fully recruit in a short period of time.
- More diversity - Expanding recruitment allows for enrolment of more patients in different parts of the world. US recruitment, in particular, has exceeded expectations and is now complete. Therefore, the additional participants will be enrolled from Roche’s network of existing trial sites in nearly 20 countries outside of the US to diversify the study population. Achieving broader global representation in clinical trials is important to Roche, as well as health authorities around the world.
Roche said –
“The community has been a critical partner throughout the development and progress of the GENERATION HD1 study. The speed of recruitment is thanks to the clinical-trial readiness and commitment of the HD medical and patient community to researching treatment options. We appreciate the partnership with the community and we look forward to providing future study updates.”
Contact
If you would like to learn more about the GENERATION HD1 you can contact the Roche UK medical information team on 0800 328 1629 or medinfo.uk@roche.com.
To learn more about Huntington's disease research take a look at the research section of our website. If you are affected by Huntington's disease and need support or advice, contact us on 0151 331 5444 or email info@hda.org.uk.
Today Roche has announced that they are increasing the total enrolment in the GENERATION HD1 study (NCT03761849) from 660 to 801 participants worldwide. The study change does not impact participants already enrolled, but it allows for additional patients to enrol in each of the three study groups.
What is the GENERATION HD1 study?
The GENERATION HD1 study evaluates the efficacy and safety of the investigational molecule RG6042 in people showing Huntington’s disease symptoms. The 25-month study is testing two dosing regimens compared to placebo - RG6042 once every two months (eight weeks) or RG6042 every four months (16 weeks). The open-label extension of the Phase I/IIa study is ongoing and supports the exploration of the two dosing groups in the GENERATION HD1 study.
Why are Roche increasing enrolment?
Roche believes that increasing enrolment now before study recruitment closes, keeps the study on track for completion within the expected timelines. Other reasons include -
- More data - The additional number of participants will provide more data to equally evaluate both dosing groups, as well as increase the statistical power of the study. In interactions with the Huntington’s community, Roche have learned the importance of testing both doses while acknowledging that less-frequent dosing wouldn’t be as demanding for patients, families and the overall healthcare system in a real-world setting.
- More confidence - Prior to GENERATION HD1, a study of this size involving investigational medicine administered via injection to the spinal cord has never been conducted in Huntington’s. Given the rate of recruitment since starting the study in the summer, Roche are confident that this larger study can fully recruit in a short period of time.
- More diversity - Expanding recruitment allows for enrolment of more patients in different parts of the world. US recruitment, in particular, has exceeded expectations and is now complete. Therefore, the additional participants will be enrolled from Roche’s network of existing trial sites in nearly 20 countries outside of the US to diversify the study population. Achieving broader global representation in clinical trials is important to Roche, as well as health authorities around the world.
Roche said –
“The community has been a critical partner throughout the development and progress of the GENERATION HD1 study. The speed of recruitment is thanks to the clinical-trial readiness and commitment of the HD medical and patient community to researching treatment options. We appreciate the partnership with the community and we look forward to providing future study updates.”
Contact
If you would like to learn more about the GENERATION HD1 you can contact the Roche UK medical information team on 0800 328 1629 or medinfo.uk@roche.com.
To learn more about Huntington's disease research take a look at the research section of our website. If you are affected by Huntington's disease and need support or advice, contact us on 0151 331 5444 or email info@hda.org.uk.