Trial · NCT00015457
Amlodipine Plus Botulinum Toxin for Focal Dystonia
NCT00015457, Phase 2, Completed, National Institute of Neurological Disorders and Stroke (NINDS); results first posted 2013-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amlodipine Plus Botulinum Toxin for Focal Dystonia. Trials, record NCT00015457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00015457
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amlodipine Plus Botulinum Toxin for Focal Dystonia
- NCT number
- NCT00015457
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- Focal Dystonia
- Interventions
- Amlodipine plus Botulinum toxin
- First posted
- 2001-04-19
- Last updated
- 2013-04-01
- Results first posted
- 2013-04-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | 3 months | Self reported duration of effect in weeks. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | 1-2 month maximal rating | Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data | units on a scale | MEAN |
| SECONDARY | Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | 3 months | Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | Amlodipine | -6.00 | Standard Deviation 10.23 | units on a scale | |
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score | Placebo | -3.23 | Standard Deviation 6.06 | units on a scale | |
| Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | Amlodipine | 6 | Full Range 1 to 12 | weeks | |
| Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo | Placebo | 5.5 | Full Range 2 to 12 | weeks |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Amlodipine Then Placebo | 8 | |
| First Intervention | STARTED | Placebo Then Amlodipine | 8 | |
| First Intervention | COMPLETED | Amlodipine Then Placebo | 8 | |
| First Intervention | COMPLETED | Placebo Then Amlodipine | 5 | |
| First Intervention | NOT COMPLETED | Amlodipine Then Placebo | 0 | |
| First Intervention | NOT COMPLETED | Placebo Then Amlodipine | 3 | |
| Second Intervention | STARTED | Amlodipine Then Placebo | 8 | |
| Second Intervention | STARTED | Placebo Then Amlodipine | 5 | |
| Second Intervention | COMPLETED | Amlodipine Then Placebo | 7 | |
| Second Intervention | COMPLETED | Placebo Then Amlodipine | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hypereosinophila | Blood and lymphatic system disorders | Amlodipine | 1 | 16 | 1 |
| other | hypereosinophila | Blood and lymphatic system disorders | Placebo | 0 | 16 | 0 |
| other | dysphagia | General disorders | Amlodipine | 0 | 16 | 0 |
| other | dysphagia | General disorders | Placebo | 1 | 16 | 1 |
| other | swelling | Skin and subcutaneous tissue disorders | Amlodipine | 1 | 16 | 1 |
| other | swelling | Skin and subcutaneous tissue disorders | Placebo | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Amlodipine | 2 | 16 |
| Total, other adverse events | Placebo | 2 | 16 |
| Total, serious adverse events | Amlodipine | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amlodipine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00015457
GET https://conductscience.org/api/trials/v1/NCT00015457/registered