Apathy Cure Through Bupropion in Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01914965
• Date of registration: 31/07/2013
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Apathy Cure Through Bupropion in Huntington's Disease Action-HD
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01914965
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Josef Priller, MD
• Affiliation: Charite University, Berlin, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Verified HD mutation carriers aged 25 to 75 years (inclusive) at first dosing

2. Apathetic as diagnosed by SCIA-D criteria

3. Stable concomitant medication (no change of medication during last six weeks prior to
inclusion)

4. 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

5. 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

Exclusion criteria:

1. Pregnant or nursing women

2. Active suicidality based on the answer "yes" in questions 4 and 5 of the
Columbia-Suicide Severity Rating Scale (baseline version)

3. 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

4. Male not using an acceptable barrier method for contraception and donating sperm from
screening up to three months following treatment

5. Presence or history of any medically not controllable disease (e.g. uncontrolled
arterial hypertension or diabetes mellitus)

6. Presence or history of seizures or diagnosed epilepsy or history of severe head
trauma (contusion) or CNS tumor

7. Clinical significant renal (calculated creatine clearance < 60 ml/min) or hepatic
dysfunction

8. Clinical significant depression defined by the NPI depression score (score =4 points)
at screening

9. Schizophreniform psychosis within the last 6 months prior to first dose

10. History of anorexia or bulimia

11. Severe cognitive disorders defined as a score < 18 in the Mini- Mental State
Examination (MMSE) at screening

12. Marked chorea (UHDRS 4) of face, BOL, trunk or extremities

13. 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

14. Known hypersensitivity reaction associated with bupropion, gelatine, lactose or
magnesium stearate

15. 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

16. Acute disease state (e.g. nausea, vomiting, fever, diarrhoea, infection) within 7
days of first dose

17. Definite or suspected personal history or family history of adverse reactions or
hypersensitivity to the trial compounds (or to compounds with a similar structure)

18. Presence of illicit drug and/or alcohol abuse

19. 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

20. Subjects who are unlikely to be compliant and attend scheduled clinic visits as
required

21. Placement in an institution due to governmental or judicial authorities



Age minimum: 25 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Apathy

Huntington's Disease

Intervention(s)

Drug: Placebo

Drug: Bupropion

Primary Outcome(s)

Apathy Evaluation Scale (AES-I) [Time Frame: 10 weeks]

Secondary Outcome(s)

Activities of daily living [Time Frame: 10 weeks]

Cognitive Symptoms [Time Frame: 10 weeks]

Adverse events [Time Frame: 10 weeks]

Motor symptoms (UHDRS) [Time Frame: 10 weeks]

AES-C (clinician) [Time Frame: 10 weeks]

AES-S (self) [Time Frame: 10 weeks]

Psychiatric symptoms [Time Frame: 10 weeks]

ventral striatal and ventromedial prefrontal activation [Time Frame: 10 weeks]

Caregiver's distress [Time Frame: 10 weeks]

Quantitative grip force motor assessment [Time Frame: 10 weeks]

Secondary ID(s)

HDSY001

2009-013698-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ruhr University of Bochum

University of Ulm

University Hospital Muenster