Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.
This research is focused on finding a better way to treat impulse control disorders, like problem gambling or excessive shopping, in people living with Parkinson's disease. Currently, treatment options for these disorders can have difficult side effects or may not work well. This study will examine if a drug called pimavanserin, already approved in the US for some Parkinson's-related issues, can safely and effectively reduce these impulsive behaviours. Researchers believe pimavanserin might help by adjusting certain brain chemicals, specifically serotonin, which is thought to play a role in both Parkinson's and impulse control problems. The goal is to improve the quality of life for those affected.
At a glance
What is this study about?
This study is about finding a new and gentle way to help people with Parkinson's disease who also have what are called 'impulse control disorders' (ICDs). These are behaviours like compulsive gambling, shopping, eating, or hypersexuality, which can be very distressing and difficult to manage. While there are some ways doctors try to help with ICDs now, they often come with their own challenges, such as making Parkinson's symptoms worse or having other serious side effects. This means we don't currently have a really good, safe, and effective treatment for these issues.
That's where this new research comes in. It's looking at a medication called pimavanserin. This medicine has already been approved in the United States to treat hallucinations and delusions in people with Parkinson's disease, showing it can be helpful and generally safe for this group. Scientists believe that specific brain chemicals, particularly something called serotonin, play a big role in both Parkinson's and impulse control disorders. Since pimavanserin works by affecting how serotonin behaves in the brain, it's thought it might also be able to reduce these impulsive behaviours.
So, the main goal of this study is to carefully check if pimavanserin can help reduce impulse control disorders in people with Parkinson's disease, and to make sure it's safe to use. If successful, this could offer a much-needed new treatment option, making a big difference to the daily lives of people living with both Parkinson's and ICDs. The researchers want to understand if this medicine can improve quality of life without causing new problems.
Key takeaways
- The study explores pimavanserin for impulse control disorders (ICDs) in Parkinson's disease (PD).
- Current ICD treatments in PD are often insufficient or have significant side effects.
- Pimavanserin works on brain chemicals linked to both PD and impulsive behaviours.
- The goal is to find a safe and effective new treatment for ICDs in PD.
- Participants will be carefully monitored for symptoms and overall health.
Who may be eligible?
To join this study, you need to be an adult with Parkinson's disease between 35 and 75 years old. You must have had Parkinson's for at least a year and your impulse control disorder must have started after your Parkinson's diagnosis and after you began taking Parkinson's medications. You'll also need to be taking Parkinson's medications at a steady dose for at least one month before the study starts and be able to stick to that dose throughout.
Importantly, your impulse control disorder must be at a certain level of severity; not so mild it doesn't need treatment, but also not so severe that it would be unethical for you to take a placebo (a dummy pill) during part of the study. This is measured using a special questionnaire.
For women who could become pregnant, you would need to be using an effective method of birth control. Everyone joining the study, or their guardian, must understand and sign a consent form, and have health insurance.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have Parkinson's disease and have had it for at least one year.
- I am between 35 and 75 years old.
- My impulse control disorder started after my Parkinson's diagnosis and after starting Parkinson's medicines.
- I've been on a stable dose of Parkinson's medicines for at least one month.
- I am willing and able to use contraception if I am a woman of childbearing potential.
- I am able to understand and sign consent forms.
What does participation involve?
If you decide to take part, you'll need to attend several appointments over the course of the study. We'll ask you to take the study medication (either pimavanserin or a placebo) as directed. We'll regularly check how your Parkinson's symptoms are, how your impulse control disorders are behaving, and also look at your overall well-being, mood, and thinking skills. We will also monitor your heart health to make sure the medication is safe for you. All these assessments help us understand how the treatment is working. The exact number of visits and the full duration of your involvement will be clearly explained before you agree to join.
Potential risks and benefits
Locations (16)
- Service de Neurologie et Centre d'Investigation Clinique CHRU de Besançon,Verified postcodeBesançon, France
- SERVICE DE NEUROLOGIE Unité Mouvement anormaux Centre expert Parkinson (centre coordinateur interrégional pour la région Sud-Est) Service de neurologie C Hôpitaux Universitaires de Lyon Hôpital Neurologique Pierre WertheimerVerified postcodeBron, France
- SERVICE DE NEUROLOGIE Unité Mouvement anormaux Centre expert Parkinson (région Sud-Est) Hôpitaux Universitaires de Clermont-Ferrand Hôpital Gabriel MontpiedVerified postcodeClermont-Ferrand, France
- SERVICE DE NEUROLOGIE Pathologies du mouvement Centre expert Parkinson (région Ile-de-France) Hôpital Henri MondorVerified postcodeCréteil, France
- SERVICE DE NEUROLOGIE Pathologies du mouvement Centre expert Parkinson (région Sud-Est) CHU de Grenoble AlpesVerified postcodeGrenoble, France
- SERVICE DE NEUROLOGIE Unité Mouvement anormaux Centre expert Parkinson (centre de coordination pour la région Nord-Ouest) Hôpitaux Universitaires de Lille Hôpital Roger SalengroVerified postcodeLille, France
- SERVICE DE NEUROLOGIE Pathologies du mouvement Centre expert Parkinson (région Sud-Ouest) Hôpitaux Universitaires de LimogesVerified postcodeLimoges, France
- SERVICE DE NEUROLOGIE Unité Mouvement anormaux Centre expert Parkinson (centre de coordination pour la région Sud Méditerranée) Hôpitaux Universitaires de Marseille Hôpital La TimoneVerified postcodeMarseille, France
- SERVICE DE NEUROLOGIE Pathologies du mouvement Centre expert Parkinson (centre de coordination pour la région Ouest) Centre d'investigation clinique Hôpitaux Universitaires de NantesVerified postcodeNantes, France
- SERVICE DE NEUROLOGIE Centre expert Parkinson (centre de coordination pour la région Ile-de-France) Hôpital de la Pitié-SalpêtrièreVerified postcodeParis, France
- CIC Hôpitaux Universitaires de PoitiersVerified postcodePoitiers, France
- Service de neurologie, Hôpitaux Universitaires de REIMSVerified postcodeReims, France
Common questions
What are Impulse Control Disorders (ICDs)?
ICDs are behaviours like problem gambling, compulsive shopping, overeating, or increased sexual urges that can be hard to control and cause distress.
What is pimavanserin?
Pimavanserin is a medication that works on certain brain chemicals. It's already approved in the US for other Parkinson's-related issues, and this study will see if it helps with ICDs.
Will I definitely get the active medication?
No, in this type of study, participants are randomly assigned to receive either the active medication (pimavanserin) or a placebo (a dummy pill).
How long will the study last?
The study involves a treatment period of 8 weeks. Your total involvement and number of visits will be explained in detail if you are considered for the study.
What is 'dopaminergic medication'?
These are medications commonly used to treat Parkinson's disease, like levodopa or dopamine agonists.
How to find out more
Mathieu ANHEIM, MD PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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