Trial record 15 of 62 for:
Essential Tremor
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
This study is not yet open for participant recruitment.
Verified December 2011 by University of Pecs
Sponsor:
University of Pecs
Information provided by (Responsible Party):
Dr. Norbert Kovacs, University of Pecs
ClinicalTrials.gov Identifier:
NCT01441284
First received: September 21, 2011
Last updated: December 15, 2011
Last verified: December 2011
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Purpose
Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Tremor |
Drug: pramipexole Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential tremor
MedlinePlus related topics:
Tremor
U.S. FDA Resources
Further study details as provided by University of Pecs:
Primary Outcome Measures:
- Improvement in tremor severity [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
Secondary Outcome Measures:
- Improvement in quality of life [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]Improvement in quality of life assessed by EQ-5D score
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Process 1
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
|
Drug: pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Other Name: Mirapexin retard
Drug: placebo
placebo
|
|
Placebo Comparator: Process 2
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
|
Drug: pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Other Name: Mirapexin retard
Drug: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441284
Contacts
| Contact: Norbert Kovacs, MD, PhD | +3672536001 ext 7642 | kovacsnorbert06@gmail.com |
Locations
| Hungary | |
| Department of Neurology, University of Pécs | Not yet recruiting |
| Pécs, Baranya Megye, Hungary, H-7623 | |
| Contact: Norbert Kovacs, MD, PhD +3672536001 ext 37642 kovacsnorbert06@gmail.com | |
| Principal Investigator: Norbert Kovacs, MD, PhD | |
| Kaposi Mór County Hospital | Not yet recruiting |
| Kaposvár, Somogy Megye, Hungary, H-7400 | |
| Contact: Ferenc Nagy, MD, PhD fnagy8@yahoo.com | |
| Principal Investigator: Ferenc Nagy, MD, PhD | |
Sponsors and Collaborators
University of Pecs
Investigators
| Principal Investigator: | Norbert Kovacs, MD, PhD | Associate professor |
More Information
No publications provided
| Responsible Party: | Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs |
| ClinicalTrials.gov Identifier: | NCT01441284 History of Changes |
| Other Study ID Numbers: | AOK_KA_2011_pramipexole, 34039/KA-OTKA/11-10 |
| Study First Received: | September 21, 2011 |
| Last Updated: | December 15, 2011 |
| Health Authority: | Hungary: Institutional Ethics Committee |
Keywords provided by University of Pecs:
|
pramipexole essential tremor cross-over |
Additional relevant MeSH terms:
|
Tremor Essential Tremor Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 21, 2013