Essential TremorPhase 2NCT00655278
T2000 in Essential Tremor - Open Label Continuation
A Phase 2 study testing T2000 in people with Essential Tremor, run by Sun Pharmaceutical Industries, Inc. at 3 sites in Canada.
Trial summary
This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over an 18 month period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- T2000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2007to Dec 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be enrolled following completion of a dose escalation trial (such as T2000-0533)
- Confirmed essential tremor by NIH criteria
- Significant functional activity limitation due to ET
- Patients who have failed, are inadequately treated or cannot tolerate alternative treatments for ET as well as treatment naïve patients who have considered but declined alternative treatment
Who cannot join
- Patients adequately controlled without side effects on a current ET treatment
- Pregnant patients or patients who may become pregnant during the study
- Patients with other medical conditions that may cause tremor, such as Parkinson's disease or active hyperthyroidism
- Patients taking medications that might produce tremor or interfere with the evaluation of tremor such as CNS-stimulants or beta-blockers
- Patients who must take medications that alter liver metabolism as well as patients with liver disease or coagulation disorders
- Patients with seizure disorders
- Patients with a history of allergy or hypersensitivity reaction to barbiturates or other related medications, such as phenobarbital or phenytoin
- Patient with significant general medical or clinical laboratory abnormalities
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Investigator Site
London, Ontario
Investigator Site
Ottawa, Ontario
Investigator Site
Toronto, Ontario
About this study
Official title: Phase II Efficacy and Safety of Taro Pharmaceuticals' Pro-Drug T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric Acid) in Patients With Essential Tremor: An Open-Label Dose Continuation Study
This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over an 18 month period.
Read the detailed description
Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's disease. The medications that are currently used to treat ET work in a small proportion of patients and provide only partial improvement in symptoms. Use of these current medications is also limited by side-effects in many patients.
T2000 is a medication currently under development for the treatment of essential tremor. Although T2000 is a new medication, it belongs to a class of medications that has been used for many years for the treatment of a variety of medical conditions. In previous studies, T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET had major improvements in tremor. In some patients T2000 was well tolerated for periods up to 5 months and the minimal side-effects seen were those that would be expected for medications in this class.
The current study will evaluate the safety and efficacy of T2000 in patients with moderate to severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day, followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 18 months. Patient's tremor and neurological examination will be monitored throughout the study.
- Conditions
- Essential Tremor
- Being tested
- T2000
- Keywords
- Movement Disorder
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2000Drug
T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | T2000 at 600-1000 mg daily Receives: Drug: T2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks.
Measured: Up to 18 months
Secondary outcomes (1)
Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655278
- Sponsor's protocol ID
- T2000-0639
- Status last verified
- Nov 2013
- First submitted
- 3 Apr 2008
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melmed C, Moros D, Rutman H. Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid). Mov Disord. 2007 Apr 15;22(5):723-7. doi: 10.1002/mds.21321.
PubMed 17265458
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Efficacy and Safety of Taro Pharmaceuticals' Pro-Drug T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric Acid) in Patients With Essential Tremor: An Open-Label Dose Continuation Study
- ClinicalTrials.gov ID
- NCT00655278
- Acronym / sponsor ID
- T2000-0639
- Conditions
- Essential Tremor
- Keywords
- Movement Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Apr 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 study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over an 18 month period.
Detailed description
Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's disease. The medications that are currently used to treat ET work in a small proportion of patients and provide only partial improvement in symptoms. Use of these current medications is also limited by side-effects in many patients.
T2000 is a medication currently under development for the treatment of essential tremor. Although T2000 is a new medication, it belongs to a class of medications that has been used for many years for the treatment of a variety of medical conditions. In previous studies, T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET had major improvements in tremor. In some patients T2000 was well tolerated for periods up to 5 months and the minimal side-effects seen were those that would be expected for medications in this class.
The current study will evaluate the safety and efficacy of T2000 in patients with moderate to severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day, followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 18 months. Patient's tremor and neurological examination will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: T2000T2000 at 600-1000 mg daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be enrolled following completion of a dose escalation trial (such as T2000-0533)
- Confirmed essential tremor by NIH criteria
- Significant functional activity limitation due to ET
- Patients who have failed, are inadequately treated or cannot tolerate alternative treatments for ET as well as treatment naïve patients who have considered but declined alternative treatment
Key exclusion criteria (8 listed)
- Patients adequately controlled without side effects on a current ET treatment
- Pregnant patients or patients who may become pregnant during the study
- Patients with other medical conditions that may cause tremor, such as Parkinson's disease or active hyperthyroidism
- Patients taking medications that might produce tremor or interfere with the evaluation of tremor such as CNS-stimulants or beta-blockers
- Patients who must take medications that alter liver metabolism as well as patients with liver disease or coagulation disorders
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 |
|---|---|---|
| T2000T2000 at previous most effective, well-tolerated dose (600-1000mg daily) | Drug | 1 |
Primary outcome
Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks.
Time frame: Up to 18 months
1 secondary outcome
Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
Time frame: Up to 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Background: PubMed 17265458Melmed C, Moros D, Rutman H. Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid). Mov Disord. 2007 Apr 15;22(5):723-7. doi: 10.1002/mds.21321.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T2000 in people with Essential Tremor, run by Sun Pharmaceutical Industries, Inc. at 3 sites in Canada.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks. (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655278, which also lists 1 linked publication.
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 23 Dec 2013.