Focal DystoniaPhase 2NCT00015457
Amlodipine Plus Botulinum Toxin for Focal Dystonia
A Phase 2 study testing Amlodipine plus Botulinum toxin in people with Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. Study Population: 20 patients with cervical dystonia Design: Double-bind, placebo-controlled clinical trail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Dystonia
- What is being tested?
- Amlodipine plus Botulinum toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria.
- Good general health
- Focal hand dystonia or cervical dystonia
- Stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year
- Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months
- No other medications for dystonia
Who cannot join
- Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection
- Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure
- Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections
- Use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids
- Allergy to amlodipine or related compounds
- Pregnany/ nursing
Show all 10Show fewer
- Age less than 18 years of age
- Abnormal EKG
- Abnormal coagulation profile or liver function tests
- Use of anticoagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.
Read the detailed description
Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS)
- Conditions
- Focal Dystonia
- Being tested
- Amlodipine plus Botulinum toxin
- Keywords
- Writer's Cramp, Calcium Channel Antagonists, Torticollis, Chemodenervation
- Medical subject headings
- Dystonic Disorders, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine plus Botulinum toxinDrug
| Study group | Role | What they receive |
|---|---|---|
| cervical dystonia | Experimental | cervical dsytonia patinets Receives: Drug: Amlodipine plus Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.
Measured: 1-2 month maximal rating
Secondary outcomes (1)
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Self reported duration of effect in weeks.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2001 (estimated)
- Study startApr 2001
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focal DystoniaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Barbara Karp, M.D., National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015457
- Sponsor's protocol ID
- 010147
- Other IDs
- 01-N-0147
- Status last verified
- Mar 2013
- First submitted
- 18 Apr 2001
- Last updated
- 1 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.
PubMed 9783280Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.
PubMed 2300249Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
PubMed 2213039
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
- ClinicalTrials.gov ID
- NCT00015457
- Acronym / sponsor ID
- 010147
- Conditions
- Focal Dystonia
- Keywords
- Writer's Cramp, Calcium Channel Antagonists, Torticollis, Chemodenervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Apr 2009 (actual)
- First posted
- 19 Apr 2001 (estimated)
- Results
- Posted 1 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.
Detailed description
Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical dystonia | Experimental | Drug: Amlodipine plus Botulinum toxincervical dsytonia patinets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria.
- Good general health
- Focal hand dystonia or cervical dystonia
- Stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year
- Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months
Key exclusion criteria (10 listed)
- Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection
- Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure
- Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections
- Use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids
- Allergy to amlodipine or related compounds
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 |
|---|---|---|
| Amlodipine plus Botulinum toxin | Drug | cervical dystonia |
Primary outcome
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
Time frame: 1-2 month maximal rating
Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.
1 secondary outcome
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9783280Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.
- Background: PubMed 2300249Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.
- Background: PubMed 2213039Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amlodipine plus Botulinum toxin in people with Focal Dystonia, 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 6 inclusion and 10 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 1 Apr 2013. 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.
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?
Yes. Results are posted in the registry (first posted 1 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score (time frame: 1-2 month maximal rating). 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 NCT00015457, which also lists 3 linked publications.
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 1 Apr 2013.