NCT00015457

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2001

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4 years until next milestone

Results Posted

Study results publicly available

April 1, 2013

Completed
Last Updated

April 1, 2013

Status Verified

March 1, 2013

Enrollment Period

8 years

First QC Date

April 18, 2001

Results QC Date

March 14, 2013

Last Update Submit

March 14, 2013

Conditions

Focal Dystonia

Keywords

Writer's CrampCalcium Channel AntagonistsTorticollisChemodenervation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-2 month maximal rating

Secondary Outcomes (1)

  • Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo

    3 months

Study Arms (1)

cervical dystonia

EXPERIMENTAL

cervical dsytonia patinets

Drug: Amlodipine plus Botulinum toxin

Interventions

Amlodipine plus Botulinum toxinDRUG
cervical dystonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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
  • Age less than 18 years of age
  • Abnormal EKG
  • Abnormal coagulation profile or liver function tests
  • Use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.

    PMID: 9783280BACKGROUND

  • Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.

    PMID: 2300249BACKGROUND

  • Jankovic 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.

    PMID: 2213039BACKGROUND

MeSH Terms

Conditions

Dystonic DisordersTorticollis

Interventions

AmlodipineBotulinum Toxins

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesDystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Barbara I Karp, MD
Organization
National Institutes of Health
karpb@ninds.nih.gov
301-496-0150

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 19, 2001

Study Start

April 1, 2001

Primary Completion

April 1, 2009

Last Updated

April 1, 2013

Results First Posted

April 1, 2013

Record last verified: 2013-03

Locations

US(1)