Essential TremorPhase 4NCT00584376
Pregabalin (Lyrica) for the Treatment of Essential Tremor
A Phase 4 study testing Pregabalin in people with Essential Tremor, run by University of South Florida at 8 sites in United States.
Trial summary
This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2007to Nov 2010
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with essential tremor diagnosed by a movement disorder specialist.
- Age 18 years to 80 years.
- Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
- Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
- Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year).
- Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
Who cannot join
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
- Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.
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- Presence of severe daytime sleepiness.
- Abnormal creatine kinase and/or platelet count in the past year.
- Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
- Previous lack of response to other ET therapies (propranolol AND primidone).
- Patients who have had deep brain stimulation (DBS).
- Concomitant treatment with gabapentin.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory Univ. School of Medicine
Atlanta, Georgia, 30329
Medical College of Georgia
Augusta, Georgia, 30912
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Vanderbilt
Nashville, Tennessee, 37232
Southern Illinois U. School of Medicine
Springfield, Illinois, 62794
University of South Florida
Tampa, Florida, 33612
About this study
Official title: A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.
- Conditions
- Essential Tremor
- Being tested
- Pregabalin, Placebo
- Keywords
- Essential tremor, tremor, pregabalin, lyrica
- Medical subject headings
- Essential Tremor, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
PlaceboDrug
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Pregabalin Receives: Drug: Pregabalin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
Measured: 61 days
Secondary outcomes (1)
Writing tablet recordings of tremor amplitude
Measured: 61 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Theresa Zesiewicz, University of South Florida
- Investigators
- Theresa A Zesiewicz, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584376
- Sponsor's protocol ID
- 2
- Status last verified
- Jun 2012
- First submitted
- 20 Dec 2007
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
- ClinicalTrials.gov ID
- NCT00584376
- Acronym / sponsor ID
- 2
- Conditions
- Essential Tremor
- Keywords
- Essential tremor, tremor, pregabalin, lyrica
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Jan 2008 (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.
This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PregabalinPregabalin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatients with essential tremor diagnosed by a movement disorder specialist.
- Age 18 years to 80 years.
- Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
- Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
Key exclusion criteria (12 listed)
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
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 |
|---|---|---|
| PregabalinGradually titrated dose ranging from 75mg po bid to 225mg po bid. | Drug | 1 |
| PlaceboPlacebo capsules which are identical in packaging, appearance and dosing as the active capsules. | Drug | 2 |
Primary outcome
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
Time frame: 61 days
1 secondary outcome
Writing tablet recordings of tremor amplitude
Time frame: 61 days
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 18 Jun 2012.
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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.
Theresa A Zesiewicz, MD principal investigator
University of South Florida
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Essential Tremor, run by University of South Florida at 8 sites in United States.
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 7 inclusion and 12 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 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score (time frame: 61 days). 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 18 Jun 2012.