Back to resultsEfficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
Primary Purpose
Essential Tremor
Status
Withdrawn
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
pramipexole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring pramipexole, essential tremor, cross-over
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
- Tremor has to be severe enough to produce disability.
- Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs
Exclusion Criteria:
- Exclusion criteria are established in accordance to the guidelines of Elble et al3.
- Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
- Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
- Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
- Presence or suspicion of psychogenic tremor
- Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
- Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
- Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
- Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
- Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)
Sites / Locations
- Department of Neurology, University of Pécs
- Kaposi Mór County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Process 1
Process 2
Arm Description
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
Outcomes
Primary Outcome Measures
Improvement in tremor severity
Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
Secondary Outcome Measures
Improvement in quality of life
Improvement in quality of life assessed by EQ-5D score
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01441284
Brief Title
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
Official Title
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of financial support
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.
Detailed Description
Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.
Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, >50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.
In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.
The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
pramipexole, essential tremor, cross-over
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Process 1
Arm Type
Active Comparator
Arm Description
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
Arm Title
Process 2
Arm Type
Placebo Comparator
Arm Description
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
Intervention Type
Drug
Intervention Name(s)
pramipexole
Other Intervention Name(s)
Mirapexin retard
Intervention Description
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Improvement in tremor severity
Description
Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
Time Frame
10 weeks of treatment
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
Improvement in quality of life assessed by EQ-5D score
Time Frame
10 weeks of treatment
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
10 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
Tremor has to be severe enough to produce disability.
Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs
Exclusion Criteria:
Exclusion criteria are established in accordance to the guidelines of Elble et al3.
Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
Presence or suspicion of psychogenic tremor
Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Kovacs, MD, PhD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Pécs
City
Pécs
State/Province
Baranya Megye
ZIP/Postal Code
H-7623
Country
Hungary
Facility Name
Kaposi Mór County Hospital
City
Kaposvár
State/Province
Somogy Megye
ZIP/Postal Code
H-7400
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
22318193
Citation
Herceg M, Nagy F, Pal E, Janszky J, Kesmarky I, Komoly S, Kovacs N. Pramipexole may be an effective treatment option in essential tremor. Clin Neuropharmacol. 2012 Mar-Apr;35(2):73-6. doi: 10.1097/WNF.0b013e31824687bf.
Results Reference
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Learn more about this trial
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
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