Focal Dystonia
Conditions
Keywords
Writer's Cramp, Calcium Channel Antagonists, Torticollis, Chemodenervation
Brief 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. 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)
Interventions
DRUGAmlodipine plus Botulinum toxin
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | 3 months | Self reported duration of effect in weeks. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from a medical clinic providing botulinum toxin treatment for cervical dystonia. Patients recruited between 6/21/01 and 10/19/06
Pre-assignment details
Patients were excluded if response to previous btx injections were not stable, serious medical conditions, pregnancy, abnormal medical screening
Participants by arm
| Arm | Count |
|---|---|
| Cervical Dystonia All participants enrolled in study | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 2 |
| First Intervention | Lack of Efficacy | 0 | 1 |
| Second Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cervical Dystonia |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
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.
Time frame: 1-2 month maximal rating
Population: Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amlodipine | Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | -6.00 units on a scale | Standard Deviation 10.23 |
| Placebo | Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | -3.23 units on a scale | Standard Deviation 6.06 |
Secondary
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
Self reported duration of effect in weeks.
Time frame: 3 months
Population: Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amlodipine | Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | 6 weeks |
| Placebo | Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | 5.5 weeks |