Trigeminal NeuralgiaNCT00004431
Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
A study testing L-baclofen in people with Trigeminal Neuralgia, run by University of Pittsburgh at 1 site in United States.
Trial summary
OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia. II. Evaluate the safety and tolerance of L-baclofen in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- L-baclofen
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Sep 1999
- Phase
- Interventional
- 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
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Idiopathic trigeminal neuralgia - Paroxysmal attacks of facial or frontal pain lasting a few seconds to less than 2 minutes - Pain has at least 4 of the following characteristics: Distribution along one or more divisions of the trigeminal nerve Sudden, intense, sharp, superficial, stabbing, or burning quality Pain intensity severe Precipitation from trigger areas, or by certain daily activities such as eating, talking, washing the face, or cleaning the teeth Between paroxysms entirely asymptomatic - No neurological deficit - Attacks are stereotyped in the individual patient - Exclusion of other causes of facial pain by history, physical examination and special investigations when necessary Must be uncontrolled or refractory as defined by occurrence of at least 2 paroxysms of pain per day despite conventional treatment with maximally tolerated doses of carbamazepine --Prior/Concurrent Therapy-- No concurrent medication for trigeminal neuralgia other than carbamazepine, phenytoin, and neurontin Concurrent medication for other conditions allowed Concurrent medication must be on stable dose(s) --Patient Characteristics-- Hepatic: No significant hepatic disease Renal: No significant renal disease Neurological: No evidence of progressing neurological disorder (e.g., intracranial neoplasm, multiple sclerosis) Other: No history of drug abuse Not pregnant Effective contraception required of all fertile patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261
About this study
OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia.
II. Evaluate the safety and tolerance of L-baclofen in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, parallel study.
Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week. Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period.
Patients, thereafter, may enroll in a long term open label study with L-baclofen.
Patients are followed at 1, 3, 6, 9, and 12 months.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Trigeminal Neuralgia
- Being tested
- L-baclofen
- Keywords
- neurologic and psychiatric disorders, rare disease, trigeminal neuralgia
- Medical subject headings
- Trigeminal Neuralgia, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-baclofenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJun 1998
- Study completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Michael J. Soso, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004431
- Sponsor's protocol ID
- 199/13391
- Other IDs
- UPSOM-950686-9608, UPSOM-FDR000914
- Status last verified
- Apr 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT00004431
- Acronym / sponsor ID
- 199/13391
- Conditions
- Trigeminal Neuralgia
- Keywords
- neurologic and psychiatric disorders, rare disease, trigeminal neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 1998
- Study completion
- Sep 1999
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia.
II. Evaluate the safety and tolerance of L-baclofen in these patients.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, parallel study.
Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week. Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period.
Patients, thereafter, may enroll in a long term open label study with L-baclofen.
Patients are followed at 1, 3, 6, 9, and 12 months.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| L-baclofen | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
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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.
Michael J. Soso study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-baclofen in people with Trigeminal Neuralgia, run by University of Pittsburgh at 1 site 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?
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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 25 Mar 2015.