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Tourette’s disorder – Trials in Disease

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Clinical Trials for Tourette’s Disorder

Five clinical trials are currently underway across Europe to study new treatments for Tourette’s disorder, a neurological condition characterized by repetitive, involuntary movements and vocalizations called tics. These studies are testing several investigational medications, including ecopipam, gemlapodect, dronabinol with palmidrol, and aripiprazole, in children, adolescents, and adults. Trials are being conducted in multiple countries including Germany, France, Spain, Poland, Hungary, and others.

Clinical trial locations

Study on Impulsivity Control in Adults with Tourette Syndrome Using [18F]-Altanserin and Aripiprazole

This study, conducted in France, explores how the brain’s serotonergic system is involved in controlling impulsive behavior in adults with Tourette’s disorder. The research focuses on understanding the relationship between certain brain receptors and changes in impulsivity levels.

Main inclusion criteria: Participants must be adults aged 18 to 65 years with a confirmed diagnosis of Tourette’s disorder according to DSM-5 criteria. They must already have treatment with aripiprazole planned as part of their routine care. Both men and women can participate, and all participants must be members of the French social security system and provide written informed consent. Female participants must use effective contraception during the study.

Main exclusion criteria: Individuals without a confirmed diagnosis of Tourette’s disorder cannot participate. Those outside the specified age range are also excluded.

Focus and goal: The study aims to investigate whether changes in the availability of serotonergic 5-HT2A receptors in the brain correlate with improvements in impulsivity in people with Tourette’s disorder. Participants undergo brain imaging using specialized techniques to observe how the brain responds to treatment. Regular assessments measure changes in impulsivity levels and clinical scores throughout the study period.

Investigational drug: The study uses aripiprazole, taken orally as tablets, along with [18F]-altanserin administered by injection for imaging purposes. Aripiprazole is an atypical antipsychotic that works by modulating dopamine and serotonin receptors in the brain, particularly the 5-HT2A receptor believed to play a role in controlling impulsivity.

Study on the Long-Term Safety of Ecopipam Hydrochloride Tablets for Children, Adolescents, and Adults with Tourette’s Disorder

This international trial, conducted across eight European countries including Spain, Denmark, Italy, France, Poland, Hungary, Germany, and Bulgaria, evaluates the long-term safety and tolerability of ecopipam tablets over an extended period of up to 105 days.

Main inclusion criteria: Participants must have completed one of three previous studies involving ecopipam (EBS-101-TD-301, EBS-101-OL-001, or PSY-302A). The study doctor must believe that the participant benefited from ecopipam and would continue to benefit from ongoing treatment. Participants must have a confirmed diagnosis of Tourette’s disorder with both motor and vocal tics that interfere with daily activities. Female participants of childbearing potential must use highly effective contraception, and male participants must also use appropriate birth control methods. For those under 18, parental consent is required along with the participant’s assent.

Main exclusion criteria: Those who have not participated in the specified previous studies cannot join. Individuals without a diagnosis of Tourette’s disorder or those outside the eligible age range are excluded.

Focus and goal: The primary objective is to monitor the long-term safety profile of ecopipam in managing symptoms of Tourette’s disorder. Participants continue taking ecopipam tablets at varying doses based on their individual needs and previous study participation. Regular follow-up visits track any side effects or health changes over time.

Investigational drug: Ecopipam is a dopamine receptor antagonist taken orally in tablet form. Doses range from 11.2 mg to 89.6 mg. The medication works by blocking certain dopamine receptors in the brain that are involved in regulating movement and behavior, potentially helping to reduce tic symptoms.

Study on the Effects of Dronabinol and Palmidrol for Adults with Tourette Syndrome

This German trial tests a new treatment called SCI-110, which combines two active substances in a soft capsule form, for adults with Tourette’s syndrome over a 12-week period.

Main inclusion criteria: Participants must be adults between 18 and 65 years old with a DSM-5 diagnosis of Tourette’s syndrome. They must have a total tic score greater than 14 on the YGTSS-R scale and a severity score of 4 or higher on the CGI-S scale. Any existing medications for tics or other conditions must be at a stable dose for at least six weeks before joining and remain stable throughout the study. Women of childbearing potential must have a negative pregnancy test and use highly effective contraception. Men must use condoms and agree not to donate sperm for three months after the study ends.

Main exclusion criteria: Those outside the 18-65 age range or not receiving outpatient care are excluded. Individuals without a confirmed diagnosis of Tourette’s syndrome cannot participate.

Focus and goal: The study evaluates the safety, tolerability, and effectiveness of SCI-110 compared to a placebo in reducing tic severity. It is a double-blind study, meaning neither participants nor researchers know who receives the active medication or placebo. Regular assessments monitor vital signs, health metrics, and any adverse events throughout the treatment period.

Investigational drug: SCI-110 contains dronabinol, a cannabis-like compound, and palmidrol, which may help reduce inflammation and pain. The medication is taken daily as a soft capsule and is classified as a central nervous system agent. It works by modulating neurotransmitter activity in the brain to potentially reduce tic symptoms.

Study on the Effects of Ecopipam Hydrochloride for Children and Adolescents with Tourette’s Disorder

This multi-country trial across Spain, France, Denmark, Italy, Poland, Hungary, Romania, Bulgaria, and Germany investigates how well ecopipam maintains its effectiveness in treating young people with Tourette’s disorder over a 12-week treatment period followed by a randomized withdrawal phase.

Main inclusion criteria: Participants must be at least 6 years old and weigh at least 18 kg. They must have a diagnosis of Tourette’s disorder with both motor and vocal tics that interfere with normal daily routines. A minimum score of 20 on the YGTSS-TTS scale is required at both screening and baseline visits. Female participants who can become pregnant must use highly effective contraception plus a barrier method, with hormonal contraception stable for at least four weeks before screening. For participants in the EU, non-drug therapies must have been tried without success before joining.

Main exclusion criteria: Children younger than 6 years old or individuals without a confirmed diagnosis of Tourette’s disorder cannot participate. Those unable to follow study instructions, pregnant or breastfeeding women, and those who recently participated in another clinical trial are excluded.

Focus and goal: The study assesses whether ecopipam can maintain symptom control over time by comparing it to placebo. After the initial 12-week treatment period, participants enter a randomized withdrawal phase where some continue medication while others receive placebo. This helps determine how long the benefits of ecopipam last and whether symptoms return when medication is stopped.

Investigational drug: Ecopipam tablets are taken orally at doses ranging from 11.2 mg to 89.6 mg daily. As a dopamine receptor antagonist, ecopipam blocks certain brain signals thought to be involved in causing tics, potentially reducing symptom severity.

Study on the Effects of Gemlapodect for Adults and Adolescents with Tourette Syndrome

This trial, conducted in Hungary, Poland, Belgium, France, Spain, and Germany, evaluates a novel medication called gemlapodect in adults and adolescents over a 12-week period using a double-blind, placebo-controlled design.

Main inclusion criteria: Participants must be at least 18 years old (or 12-17 if regional approval for adolescents is granted) with moderate to severe Tourette syndrome. They can be new to treatment or previously treated but requiring a different approach. All medications used to treat Tourette syndrome must be stopped for at least 14 days before starting the study, though other stable mental health medications can be continued if they have been at the same dose for at least 30 days. Participants must have a Body Mass Index between 18 and 35 kg/m². Women of childbearing potential must confirm a negative pregnancy test and use appropriate contraception.

Main exclusion criteria: Individuals without Tourette syndrome or those outside the eligible age ranges cannot participate. Those who do not meet the BMI requirements are also excluded.

Focus and goal: The study aims to determine whether gemlapodect can effectively reduce tic severity scores compared to placebo. Regular assessments throughout the 12 weeks monitor changes in symptoms, body weight, blood glucose, lipids, and other health indicators. The trial also evaluates the medication’s safety profile through laboratory tests, ECGs, and vital sign monitoring.

Investigational drug: Gemlapodect is a novel PD10A inhibitor taken orally as hard capsules. It is currently in Phase IIb clinical research and works by modulating neurotransmitter activity in the brain to help control the involuntary movements and vocalizations associated with Tourette syndrome. It is classified as a central nervous system agent.

Summary

The five ongoing clinical trials for Tourette’s disorder represent diverse approaches to managing this neurological condition. Three trials focus on ecopipam, a dopamine receptor antagonist, with studies examining both its effectiveness in maintaining symptom control and its long-term safety profile. These ecopipam trials have the widest geographic reach, spanning up to nine European countries and including participants ranging from children as young as 6 years to adults.

Two other trials explore different therapeutic mechanisms: one investigates gemlapodect, a novel PD10A inhibitor, across six countries, while another tests SCI-110, a combination of dronabinol and palmidrol, exclusively in Germany. The French study takes a unique approach by examining the neurobiological underpinnings of impulsivity in Tourette’s disorder using brain imaging techniques alongside aripiprazole treatment.

Most trials are concentrated in major European research centers, with Germany, France, Spain, Poland, and Hungary hosting multiple studies. The trials primarily target moderate to severe cases and emphasize the importance of stable medication regimens before enrollment. All studies incorporate rigorous safety monitoring and use standardized scales to measure tic severity, ensuring consistent evaluation across different treatment approaches.

Ongoing Clinical Trials on Tourette’s disorder

  • Study on the Long-Term Safety of Ecopipam Hydrochloride Tablets for Children, Adolescents, and Adults with Tourette’s Disorder

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark France Germany Hungary Italy +2

  • Study on the Effects of Gemlapodect for Adults and Adolescents with Tourette Syndrome

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Poland Spain

  • Study on the Effects of Ecopipam Hydrochloride for Children and Adolescents with Tourette’s Disorder

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark France Germany Hungary Italy +3

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