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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013698-16 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Ulm | OTHER |
| Ruhr University of Bochum | OTHER |
| University Hospital Muenster | OTHER |
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The influence of bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar with the daily activities of the subject) in patients with HD after ten (10) weeks of treatment.
The safety and tolerability of Bupropion in HD.
The influence of Bupropion compared to placebo on the:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion | Active Comparator | First treatment group: 150 mg bupropion or placebo once daily for 2 weeks, followed by 300 mg bupropion or placebo once daily for subsequent 8 weeks (until week 10; visit 4) First tapering and washout: 150 mg bupropion or placebo once daily for 7 days followed by a washout phase of 1 week on placebo |
|
| Placebo | Placebo Comparator | Second treatment group (crossover): placebo or 150 mg bupropion once daily for 2 weeks, followed by placebo or 300 mg bupropion once daily for subsequent 8 weeks (until week 22; visit 6) Second tapering placebo or 150 mg bupropion once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug | Crossover design: Oral administration of 150 mg bupropion once daily for 2 weeks, followed by 300 mg bupropion once daily for subsequent 8 weeks, tapering: 150 mg bupropion once daily for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Apathy Evaluation Scale (AES-I) | The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar with the daily activities of the subject) in patients with HD after ten weeks of treatment. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AES-C (clinician) | The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-C, where C [clinician] is the trial investigator) in patients with HD after ten weeks of treatment. | 10 weeks |
| AES-S (self) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Priller, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologische Klinik der Ruhr-Universität Bochum | Bochum | 44791 | Germany | |||
| Universitätsklinikum Ulm, Klinik für Neurologie |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Crossover design: Oral administration of placebo once daily for 2 weeks, followed by placebo once daily for subsequent 8 weeks, tapering: placebo once daily for 7 days |
|
|
The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-S, where S [self] is the patient) in patients with HD after ten weeks of treatment. |
| 10 weeks |
| Motor symptoms (UHDRS) | The influence of Bupropion compared to placebo on the UHDRS motor score in patients with HD after ten weeks of treatment. | 10 weeks |
| Quantitative grip force motor assessment | The influence of Bupropion compared to placebo on motor scores in patients with HD after ten weeks of treatment. | 10 weeks |
| Cognitive Symptoms | The influence of Bupropion compared to placebo on MMSE in patients with HD after ten weeks of treatment. | 10 weeks |
| Psychiatric symptoms | The influence of Bupropion compared to placebo on UHDRS behavioural assessment in patients with HD after ten weeks of treatment. | 10 weeks |
| Activities of daily living | The influence of Bupropion compared to placebo on UHDRS Functional Assessment in patients with HD after ten weeks of treatment. | 10 weeks |
| Caregiver's distress | The influence of Bupropion compared to placebo on the NPI caregiver's distress score. | 10 weeks |
| ventral striatal and ventromedial prefrontal activation | Change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI. | 10 weeks |
| Adverse events | The safety and tolerability of Bupropion will be compared with placebo in patients with HD after ten weeks of treatment. | 10 weeks |
| Ulm |
| 89081 |
| Germany |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |