Movement DisordersNCT00001208
Botulinum Toxin for the Treatment of Involuntary Movement Disorders
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Movement Disorders
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 1989to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a movement disorder will be enrolled.
Who may be able to join
- Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.
- Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.
Who cannot join
- Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
- Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
- For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Botulinum Toxin for the Treatment of Neurological Disorders
BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response.
The application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.
Read the detailed description
The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other NIH studies.
- Conditions
- Movement Disorders
- Keywords
- Botulinum Toxin, BTW, Natural History
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX. Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Natural History- data analysis
Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.
Measured: Ongoing
Maintain cohort of subjects
To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start26 Oct 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra J Ehrlich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001208
- Sponsor's protocol ID
- 850195
- Other IDs
- 85-N-0195
- Status last verified
- 21 Oct 2026
- First submitted
- 3 Nov 1999
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD stored in the database will be shared. @@@@@@@@@@@@We may share identifiable research data with other NIH protocols, when subjects are co-enrolled. Data can be shared with other protocols, investigators, and subject health care and medical team upon subject requests and permissions. Data that may be shared are demographics, diagnosis, botulinum toxin injections (including site, dose, localication technique), response to injections, assessments from clinical evaluations and clinical rating scales or test results that are conducted for each subject. Data that is shared may be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH. @@@@@@@@@@@@
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin for the Treatment of Neurological Disorders
- ClinicalTrials.gov ID
- NCT00001208
- Acronym / sponsor ID
- 850195
- Conditions
- Movement Disorders
- Keywords
- Botulinum Toxin, BTW, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Oct 1989 (actual)
- First posted
- 4 Nov 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.
BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response.
The application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.
Detailed description
The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other NIH studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX. Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia. |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a movement disorder will be enrolled.
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
- Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
- Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
- For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study Natural History- data analysis
Time frame: Ongoing
Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.
Maintain cohort of subjects
Time frame: Ongoing
To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD stored in the database will be shared. @@@@@@@@@@@@We may share identifiable research data with other NIH protocols, when subjects are co-enrolled. Data can be shared with other protocols, investigators, and subject health care and medical team upon subject requests and permissions. Data that may be shared are demographics, diagnosis, botulinum toxin injections (including site, dose, localication technique), response to injections, assessments from clinical evaluations and clinical rating scales or test results that are conducted for each subject. Data that is shared may be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH. @@@@@@@@@@@@
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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.
Debra J Ehrlich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) 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?
The sponsor lists 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian S Koo ((301) 435-8518, vivian.koo@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Natural History- data analysis (time frame: Ongoing). The study lists 2 primary outcomes in all. 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 23 Oct 2026.