ApathyPhase 2Action-HDNCT01914965
Apathy Cure Through Bupropion in Huntington's Disease
A Phase 2 study testing Bupropion in people with Apathy and Huntington's Disease, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Apathy, Huntington's Disease
- What is being tested?
- Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2012to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified HD mutation carriers aged 25 to 75 years (inclusive) at first dosing
- Apathetic as diagnosed by SCIA-D criteria
- Stable concomitant medication (no change of medication during last six weeks prior to inclusion)
- Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study
- Patient has a caregiver (family member or friend), who is living in a close relationship with the patient and is willing to give written informed consent (caregiver) before performance of any trial-related procedure
Who cannot join
- Pregnant or nursing women
- Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version)
- Woman of childbearing potential, not using highly effective methods of contraception defined as methods with a Pearl Index < 1 such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post-menopausal
- Male not using an acceptable barrier method for contraception and donating sperm from screening up to three months following treatment
- Presence or history of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus)
- Presence or history of seizures or diagnosed epilepsy or history of severe head trauma (contusion) or CNS tumor
Show all 21Show fewer
- Clinical significant renal (calculated creatine clearance < 60 ml/min) or hepatic dysfunction
- Clinical significant depression defined by the NPI depression score (score ≥4 points) at screening
- Schizophreniform psychosis within the last 6 months prior to first dose
- History of anorexia or bulimia
- Severe cognitive disorders defined as a score < 18 in the Mini- Mental State Examination (MMSE) at screening
- Marked chorea (UHDRS 4) of face, BOL, trunk or extremities
- Treatment with neuroleptics other than tiapride, MAO-B inhibitors, amantadine, levodopa, D- or D,L-amphetamine or psychostimulants like methylphenidate, modafinil or atomoxetine within 1 month prior to first dose
- Known hypersensitivity reaction associated with bupropion, gelatine, lactose or magnesium stearate
- Clinically relevant abnormal findings in the ECG, the vitals, in the physical examination or laboratory values at screening that could interfere with the objectives of the study or the safety of the subject as judged by the investigator
- Acute disease state (e.g. nausea, vomiting, fever, diarrhoea, infection) within 7 days of first dose
- Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the trial compounds (or to compounds with a similar structure)
- Presence of illicit drug and/or alcohol abuse
- Participation in another investigative drug trial within 2 months or donation of blood within 12 weeks prior to the first dose or during the trial
- Subjects who are unlikely to be compliant and attend scheduled clinic visits as required
- Placement in an institution due to governmental or judicial authorities
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Neurologische Klinik der Ruhr-Universität Bochum
Bochum, 44791
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, 89081
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Prospective Crossover Trial Investigating the Efficacy and Safety of the Treatment With Bupropion in Patients With Apathy in Huntington's Disease
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.
Read the detailed description
The safety and tolerability of Bupropion in HD.
The influence of Bupropion compared to placebo on the:
- change of apathy as quantified by the AES-C (clinician) or the AES-S (self),
- change of motor symptoms (UHDRS) and quantitative grip force motor assessment,
- change of cognitive symptoms (UHDRS and MMSE),
- change of psychiatric symptoms (UHDRS, HADS),
- change of activities of daily living (UHDRS),
- change of the NPI caregivers' distress score (NPI-D),
- change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI.
- Conditions
- Apathy, Huntington's Disease
- Being tested
- Bupropion, Placebo
- Keywords
- Huntington's disease, Apathy, Bupropion
- Medical subject headings
- Lethargy, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Wellbutrin, Budeprion, Prexaton, Elontril, Aplenzin
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
PlaceboDrug
Also called control
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bupropion; Drug: 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 Receives: Drug: Bupropion; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (10)
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.
Measured: 10 weeks
AES-S (self)
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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Cognitive Symptoms
The influence of Bupropion compared to placebo on MMSE in patients with HD after ten weeks of treatment.
Measured: 10 weeks
Psychiatric symptoms
The influence of Bupropion compared to placebo on UHDRS behavioural assessment in patients with HD after ten weeks of treatment.
Measured: 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.
Measured: 10 weeks
Caregiver's distress
The influence of Bupropion compared to placebo on the NPI caregiver's distress score.
Measured: 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.
Measured: 10 weeks
Adverse events
The safety and tolerability of Bupropion will be compared with placebo in patients with HD after ten weeks of treatment.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, Ruhr University of Bochum, University Hospital Muenster
- Responsible party
- Principal investigator, Josef Priller, Charite University, Berlin, Germany
- Investigators
- Josef Priller, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914965
- Sponsor's protocol ID
- HDSY001
- Other IDs
- 2009-013698-16, 2009
- Acronym
- Action-HD
- Status last verified
- Sep 2014
- First submitted
- 31 Jul 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Prospective Crossover Trial Investigating the Efficacy and Safety of the Treatment With Bupropion in Patients With Apathy in Huntington's Disease
- ClinicalTrials.gov ID
- NCT01914965
- Acronym / sponsor ID
- Action-HD / HDSY001
- Conditions
- Apathy, Huntington's Disease
- Keywords
- Huntington's disease, Apathy, Bupropion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Ulm, Ruhr University of Bochum, University Hospital Muenster
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The safety and tolerability of Bupropion in HD.
The influence of Bupropion compared to placebo on the:
- change of apathy as quantified by the AES-C (clinician) or the AES-S (self),
- change of motor symptoms (UHDRS) and quantitative grip force motor assessment,
- change of cognitive symptoms (UHDRS and MMSE),
- change of psychiatric symptoms (UHDRS, HADS),
- change of activities of daily living (UHDRS),
- change of the NPI caregivers' distress score (NPI-D),
- change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Active comparator | Drug: Bupropion, Drug: PlaceboFirst 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 | Drug: Bupropion, Drug: PlaceboSecond 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 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Verified HD mutation carriers aged 25 to 75 years (inclusive) at first dosing
- Apathetic as diagnosed by SCIA-D criteria
- Stable concomitant medication (no change of medication during last six weeks prior to inclusion)
- Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study
- Patient has a caregiver (family member or friend), who is living in a close relationship with the patient and is willing to give written informed consent (caregiver) before performance of any trial-related procedure
Key exclusion criteria (21 listed)
- Pregnant or nursing women
- Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version)
- Woman of childbearing potential, not using highly effective methods of contraception defined as methods with a Pearl Index < 1 such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post-menopausal
- Male not using an acceptable barrier method for contraception and donating sperm from screening up to three months following treatment
- Presence or history of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: Wellbutrin, Budeprion, Prexaton, Elontril, AplenzinCrossover 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 | Drug | Bupropion, Placebo |
| PlaceboAlso: controlCrossover 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 | Drug | Bupropion, Placebo |
Primary outcome
Apathy Evaluation Scale (AES-I)
Time frame: 10 weeks
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 secondary outcomes
AES-C (clinician)
Time frame: 10 weeks
AES-S (self)
Time frame: 10 weeks
Motor symptoms (UHDRS)
Time frame: 10 weeks
Quantitative grip force motor assessment
Time frame: 10 weeks
Cognitive Symptoms
Time frame: 10 weeks
Psychiatric symptoms
Time frame: 10 weeks
Activities of daily living
Time frame: 10 weeks
Caregiver's distress
Time frame: 10 weeks
ventral striatal and ventromedial prefrontal activation
Time frame: 10 weeks
Adverse events
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Priller, MD principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion in people with Apathy and Huntington's Disease, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy Evaluation Scale (AES-I) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.