Apathy Cure Through Bupropion in Huntington's Disease

NCT01914965 | Completed Phase 2 DMC

• 2 other identifiers: HDSY0012009-013698-16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Apathy; Huntington's Disease

Keywords

Huntington's disease; Apathy; Bupropion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• AES-C (clinician)

  10 weeks

• AES-S (self)

  10 weeks

• Motor symptoms (UHDRS)

  10 weeks

• Quantitative grip force motor assessment

  10 weeks

• Cognitive Symptoms

  10 weeks

Study Arms (2)

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

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

Drug: Bupropion; Drug: Placebo

Interventions

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

Also known as: Wellbutrin, Budeprion, Prexaton, Elontril, Aplenzin

Bupropion; Placebo

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

Also known as: control

Bupropion; Placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified HD mutation carriers aged 25 to 75 years (inclusive) at first dosing
• Apathetic as diagnosed by SCIA-D criteria
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University of Ulm: collaborator
• Ruhr University of Bochum: collaborator
• University Hospital Muenster: collaborator

Study Sites (2)

Neurologische Klinik der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Universitätsklinikum Ulm, Klinik für Neurologie

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Lethargy; Huntington Disease

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Josef Priller, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Josef Priller

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

DE (2)